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Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888640
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Kathleen Sluka, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Intervention Device: TENS
Enrollment 301
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Period Title: Overall Study
Started 103 99 99
Completed [1] 76 68 94
Not Completed 27 31 5
Reason Not Completed
Lost to Follow-up             1             2             0
Withdrawal by Subject             15             11             4
Minimum dose not met             10             16             0
Given wrong unit (placebo)             1             0             0
Excluded for prior TENS             0             1             0
Researcher Termination of Participant             0             1             1
[1]
Per Protocol, completed visit 3
Arm/Group Title Active TENS Placebo TENS no TENS (Standard Care) Total
Hide Arm/Group Description

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study. Total of all reporting groups
Overall Number of Baseline Participants 103 99 99 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 99 participants 301 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
  94.2%
93
  93.9%
95
  96.0%
285
  94.7%
>=65 years
6
   5.8%
6
   6.1%
4
   4.0%
16
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 99 participants 99 participants 301 participants
44.7  (14.3) 47.2  (12.6) 48.6  (11.8) 46.8  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 99 participants 301 participants
Female
103
 100.0%
99
 100.0%
99
 100.0%
301
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 99 participants 301 participants
Hispanic or Latino
5
   4.9%
5
   5.1%
5
   5.1%
15
   5.0%
Not Hispanic or Latino
96
  93.2%
92
  92.9%
88
  88.9%
276
  91.7%
Unknown or Not Reported
2
   1.9%
2
   2.0%
6
   6.1%
10
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 99 participants 301 participants
American Indian or Alaska Native
2
   1.9%
1
   1.0%
0
   0.0%
3
   1.0%
Asian
1
   1.0%
2
   2.0%
1
   1.0%
4
   1.3%
Native Hawaiian or Other Pacific Islander
5
   4.9%
0
   0.0%
0
   0.0%
5
   1.7%
Black or African American
0
   0.0%
5
   5.1%
3
   3.0%
8
   2.7%
White
90
  87.4%
87
  87.9%
85
  85.9%
262
  87.0%
More than one race
4
   3.9%
3
   3.0%
5
   5.1%
12
   4.0%
Unknown or Not Reported
1
   1.0%
1
   1.0%
5
   5.1%
7
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants 99 participants 99 participants 301 participants
103 99 99 301
Pain with movement six minute walk test  
Mean (Standard Deviation)
Unit of measure:  0 to 10 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
6.5  (1.9) 6.2  (1.9) 6.4  (1.9) 6.4  (1.9)
Pain with movement five time sit to stand  
Mean (Standard Deviation)
Unit of measure:  0 to 10 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
5.8  (2.4) 5.5  (2.2) 5.6  (2.2) 5.6  (2.2)
Pain at rest  
Mean (Standard Deviation)
Unit of measure:  0 to 10 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
6.2  (1.5) 5.9  (1.4) 6.1  (1.6) 6.0  (1.5)
Fatigue at rest  
Mean (Standard Deviation)
Unit of measure:  0 to 10 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
6.8  (2.0) 6.1  (1.8) 6.4  (2.0) 6.43  (1.9)
Fibromyalgia Impact Questionnaire Revised - Pain  
Mean (Standard Deviation)
Unit of measure:  0 to 10 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
6.7  (1.8) 6.0  (1.6) 6.15  (1.8) 6.28  (1.7)
Fibromyalgia Impact Questionnaire Revised  
Mean (Standard Deviation)
Unit of measure:  Scoring 0 to 100 low to high scale
Number Analyzed 103 participants 99 participants 99 participants 301 participants
59.2  (16.8) 53.7  (15.9) 55.6  (16.0) 56.1  (16.2)
Short Form 36 Physical Component Score   [1] 
Median (Standard Deviation)
Unit of measure:  T-score mean of 50
Number Analyzed 103 participants 99 participants 99 participants 301 participants
32.7  (6.4) 33.3  (6.2) 32.7  (6.6) 32.9  (6.4)
[1]
Measure Description: The SF36 Physical Functioning Component Score (PCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life
Short Form 36 Mental Health Component Score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score mean of 50
Number Analyzed 103 participants 99 participants 99 participants 301 participants
38.7  (10.0) 40.2  (10.2) 39.5  (10.6) 39.4  (10.2)
[1]
Measure Description: The SF36 Mental Health Component Scale (MCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life
Tampa Scale of Kinesiophobia  
Mean (Standard Deviation)
Unit of measure:  Scoring 17 to 68 low to high
Number Analyzed 103 participants 99 participants 99 participants 301 participants
36.5  (7.7) 37.1  (8.0) 37.4  (8.3) 37  (8.0)
Six minute walk test (Feet)  
Mean (Standard Deviation)
Unit of measure:  Feet
Number Analyzed 103 participants 99 participants 99 participants 301 participants
1386  (323) 1358  (305) 1316  (318) 1353.3  (315)
Five time sit to stand  
Mean (Standard Deviation)
Unit of measure:  Sit-to-stand repetitions/10 seconds
Number Analyzed 103 participants 99 participants 99 participants 301 participants
4.1  (1.5) 4.0  (1.4) 3.9  (1.5) 4.0  (1.4)
Physical Activity (Moderate-Vigorous)  
Mean (Full Range)
Unit of measure:  Average Minute/Day
Number Analyzed 103 participants 99 participants 99 participants 301 participants
17.7
(7.4 to 29.0)
16.5
(6.3 to 29.1)
15.0
(7.3 to 36.0)
16.4
(6.3 to 36.0)
1.Primary Outcome
Title Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
Hide Description Numeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at 4 weeks
-1.8
(-2.3 to -1.2)
-0.8
(-1.4 to -0.2)
0.00
(-0.5 to 0.6)
Change at 8 weeks
-2.0
(-2.8 to -1.3)
-1.9
(-2.7 to -1.2)
-1.9
(-2.6 to -1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2-Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.8 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.6 to -1.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
Hide Description Numeric rating scale of 0-10 for pain with movement with five time sit to stand test. Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-1.6
(-2.30 to -1.0)
-0.3
(-1.0 to 0.3)
0.2
(-0.4 to 0.9)
Change at 8 weeks
-1.9
(-2.6 to -1.1)
-1.4
(-2.2 to -0.7)
-1.3
(-2.1 to -0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-2.2 to -0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.8 to -1.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Resting Pain (0-10 Low to High Scale)
Hide Description Numeric rating scale of 0-10 for resting pain; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-1.9
(-2.5 to -1.4)
-0.7
(-1.3 to -0.1)
-0.5
(-1.1 to 0.00)
Change at 8 weeks
-2.2
(-2.9 to -1.6)
-1.9
(-2.6 to -1.2)
-2.2
(-2.8 to -1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.1 to -0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.2 to -0.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test
Hide Description Fatigue measured with 0-10 numeric rating scale during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at 4 weeks
-1.5
(-2.2 to -0.8)
-0.1
(-0.9 to 0.7)
0.4
(-0.3 to 1.1)
Change at 8 weeks
-1.3
(-2.0 to -0.6)
-0.9
(-1.7 to -0.2)
-0.9
(-1.7 to -0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.4 to -0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.9 to -0.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand
Hide Description Fatigue measured by 0-10 numeric rating scale after five time sit to stand; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at 4 weeks
-1.2
(-1.9 to -0.5)
-0.0
(-0.8 to 0.7)
0.8
(0.1 to 1.5)
Change at 8 weeks
-1.1
(-1.9 to -0.4)
-0.8
(-1.6 to -0.1)
-0.6
(-1.4 to 0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.2 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.0 to -1.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Resting Fatigue Rating (0-10 Low to High Scale)
Hide Description Fatigue measured at rest with a 0-10 numeric rating scale; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at 4 weeks
-1.9
(-2.6 to -1.2)
-0.8
(-1.5 to -0.04)
-0.4
(-1.0 to 0.4)
Change at 8 weeks
-2.1
(-2.9 to -1.4)
-1.6
(-2.4 to -0.8)
-1.8
(-2.6 to -1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.2 to -0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-2.6 to -0.6
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Fibromyalgia Impact Questionnaire Revised
Hide Description Disease Impact self report Questionnaire, Scoring 0-100; higher score indicates greater disease impact; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Change at 4 weeks
-8.5
(-12.9 to 4.0)
-3.4
(-6.5 to 0.3)
-1.39
(-4.4 to 1.6)
Change at 8 weeks
-9.6
(-13.8 to 5.4)
-11.1
(-15.2 to 7.0)
-10.7
(-14.8 to -6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-10.4 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-12.4 to -1.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)
Hide Description numeric rating scale 0 to 10 from the Fibromyalgia Impact Questionnaire Revised: Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-1.3
(-1.8 to -0.7)
-0.4
(-0.9 to -0.2)
-0.1
(-0.6 to 0.4)
Change at 8 weeks
-1.4
(-2.0 to -0.8)
-1.2
(-1.7 to -0.6)
-1.4
(-1.9 to -0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.7 to -0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.9 to -0.4
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Brief Pain Inventory - Interference (0-10 Low to High Scale)
Hide Description Brief Pain Inventory - Interference; Score 0-10 with higher score indicating greater interference; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-0.9
(-1.4 to -0.5)
-0.3
(-0.7 to 0.2)
-0.3
(-0.7 to 0.2)
Change at 8 weeks
-1.1
(-1.6 to -0.6)
-0.9
(-1.4 to -0.3)
-1.2
(-1.7 to -0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.3 to -0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.3 to -0.0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Brief Pain Inventory, Intensity (0-10 Low to High Scale)
Hide Description Brief Pain Inventory - Interference, Scale of 0-10 with higher score indicating greater intensity; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-0.8
(-1.1 to -0.4)
-0.3
(-0.6 to 0.1)
0.15
(-0.2 to 0.5)
Change at 8 weeks
-1.0
(-1.4 to -0.6)
-0.9
(-1.3 to -0.5)
-0.9
(-1.2 to -0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.0 to -0.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.4 to -0.4
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Tampa Scale of Kinesiophobia (17 to 68 Low to High)
Hide Description Self report questionnaire with higher scores indicating greater kinesiophobia, score 17-68; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at 4 weeks
-0.7
(-2.0 to 0.6)
-0.3
(-1.7 to 1.0)
-0.2
(-1.4 to 1.1)
Change at 8 weeks
-0.3
(-1.6 to 1.1)
-2.3
(-3.7 to -0.9)
-3.3
(-4.6 to -2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.3 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.4 to 1.3
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Short Form Survey 36; Mental Component Score (T Score Mean of 50)
Hide Description

Multidimensional Self Report Questionnaire, T-score; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups

The SF36 Mental Health Component Score (MCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life

Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: T-Score
Change at 4 weeks
2.3
(0.2 to 4.4)
1.2
(-0.9 to 3.4)
-0.04
(-2.1 to 2.0)
Change at 8 weeks
2.1
(-0.2 to 4.4)
3.6
(1.3 to 6.0)
2.8
(0.6 to 5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-1.9 to 4.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-0.6 to 5.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health
Hide Description

Multidimensional self report scale, T score change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups

The SF36 Physical Functioning Component Score (PCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life .

Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: T-Score
Change at 4 weeks
2.4
(1.0 to 3.7)
1.2
(-0.2 to 2.5)
1.4
(0.1 to 2.6)
Change at 8 weeks
3.5
(2.0 to 5.1)
3.2
(1.6 to 4.8)
4.4
(2.9 to 5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-0.7 to 3.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.8 to 2.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Six Minute Walk Test
Hide Description 6MWT - Feet walked as fast as comfortable in six minute; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Feet
Change at 4 weeks
-1
(-55 to 54)
-20
(-75 to 36)
-42.1
(-95 to 11)
Change at 8 weeks
15
(-42 to 71)
16
(-41 to 74)
-2
(-57 to 53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19
Confidence Interval (2-Sided) 95%
-58 to 96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 42
Confidence Interval (2-Sided) 95%
-34 to 117
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Five Time Sit to Stand Test Rate Per 10 Seconds
Hide Description Time for sit to stand for 5 repetitions converted to a rate of number of sit to stand per 10 seconds; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: sit-to-stand repetitions/10 seconds
Change at 4 weeks
0.6
(0.3 to 1.0)
0.4
(0.0 to 0.7)
0.1
(-0.3 to 0.4)
Change at 8 weeks
0.6
(0.2 to 1.0)
0.8
(0.4 to 1.3)
0.6
(0.1 to 1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.2 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.1 to 1.0
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Moderate Vigorous Physical Activity Minutes Per Day
Hide Description Accelerometry data classification of physical activity in minutes per day, percent change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Time Frame Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care)
Hide Arm/Group Description:

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 2-125 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Overall Number of Participants Analyzed 103 99 99
Mean (95% Confidence Interval)
Unit of Measure: Minutes per day
Change at 4 weeks
-9.4
(-27.8 to 13.5)
2.5
(-18.6 to 29.1)
-14.1
(-29.5 to 4.7)
Change at 8 weeks
-6.8
(-27.2 to 19.3)
-0.3
(-22.3 to 27.9)
-17.0
(-33.9 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TENS, Placebo TENS
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active TENS, No TENS (Standard Care)
Comments Visit 2 to Visit 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Linear mixed models for repeated measure
Comments [Not Specified]
Time Frame Visit 1 to Visit 4, 9 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active TENS Placebo TENS No TENS (Standard Care) Pre-Randomization
Hide Arm/Group Description

Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.

TENS: TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study. Participants who attended visit 1 or 2 prior to randomization to intervention
All-Cause Mortality
Active TENS Placebo TENS No TENS (Standard Care) Pre-Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/103 (0.00%)      0/99 (0.00%)      0/99 (0.00%)      0/352 (0.00%)    
Hide Serious Adverse Events
Active TENS Placebo TENS No TENS (Standard Care) Pre-Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/103 (0.00%)      1/99 (1.01%)      2/99 (2.02%)      1/352 (0.28%)    
Cardiac disorders         
Chest pain  [1]  0/103 (0.00%)  0 1/99 (1.01%)  1 0/99 (0.00%)  0 0/352 (0.00%)  0
Chest pain   0/103 (0.00%)  0 0/99 (0.00%)  0 0/99 (0.00%)  0 1/352 (0.28%)  1
Gastrointestinal disorders         
Dehydration and gastrointestinal pain  [2]  0/103 (0.00%)  0 0/99 (0.00%)  0 1/99 (1.01%)  1 0/352 (0.00%)  0
Psychiatric disorders         
Depression  [3]  0/103 (0.00%)  0 0/99 (0.00%)  0 1/99 (1.01%)  1 0/352 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject with chest pain between visits with emergency department visit and hospitalization; non-study related, recovered with treatment
[2]
Participant admitted to hospital for complaint of dehydration
[3]
Hospitalization for depression
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Active TENS Placebo TENS No TENS (Standard Care) Pre-Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/103 (11.65%)      10/99 (10.10%)      15/99 (15.15%)      0/352 (0.00%)    
General disorders         
Pain with TENS; At home, unspecified   4/103 (3.88%)  4 4/99 (4.04%)  4 3/99 (3.03%)  3 0/352 (0.00%)  0
Fall   4/103 (3.88%)  4 3/99 (3.03%)  3 2/99 (2.02%)  2 0/352 (0.00%)  0
Headache or Migraine   3/103 (2.91%)  3 3/99 (3.03%)  3 1/99 (1.01%)  1 0/352 (0.00%)  0
Dental Procedures   2/103 (1.94%)  2 2/99 (2.02%)  2 3/99 (3.03%)  3 0/352 (0.00%)  0
Infections and infestations         
Bladder Infection   2/103 (1.94%)  2 2/99 (2.02%)  2 2/99 (2.02%)  2 0/352 (0.00%)  0
Sinus Infection   2/103 (1.94%)  2 2/99 (2.02%)  2 2/99 (2.02%)  2 0/352 (0.00%)  0
Nervous system disorders         
Pain with testing  [1]  12/103 (11.65%)  12 10/99 (10.10%)  10 15/99 (15.15%)  15 0/352 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Upper Respiratory  [2]  7/103 (6.80%)  7 7/99 (7.07%)  7 3/99 (3.03%)  3 0/352 (0.00%)  0
Common Cold   3/103 (2.91%)  3 4/99 (4.04%)  4 2/99 (2.02%)  2 0/352 (0.00%)  0
Upper Respiratory Infection   7/103 (6.80%)  7 7/99 (7.07%)  7 3/99 (3.03%)  3 0/352 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin Irritation from actigraph band   2/103 (1.94%)  2 3/99 (3.03%)  3 1/99 (1.01%)  1 0/352 (0.00%)  0
Skin Irritation with Electrodes   6/103 (5.83%)  6 2/99 (2.02%)  2 0/99 (0.00%)  0 0/352 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Increase in pain with testing at clinic visit
[2]
Report of upper respiratory infection or difficulty during the study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kathleen A. Sluka
Organization: University of Iowa
Phone: 319-335-9791
EMail: kathleen-sluka@uiowa.edu
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kathleen Sluka, University of Iowa
ClinicalTrials.gov Identifier: NCT01888640    
Other Study ID Numbers: 201110717
First Submitted: June 13, 2013
First Posted: June 28, 2013
Results First Submitted: June 24, 2019
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019