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Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

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ClinicalTrials.gov Identifier: NCT00942890
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
University of Tennessee

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Traumatic Amputation
Interventions Device: NMES (EMPI 300PV stimulator) plus standard of care
Behavioral: TMARP standard of care
Enrollment 44
Recruitment Details  
Pre-assignment Details There was a total of 44 participants.
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 wk after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation. NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Period Title: Overall Study
Started 21 23
Completed 21 23
Not Completed 0 0
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol Total
Hide Arm/Group Description The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation. NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits. Total of all reporting groups
Overall Number of Baseline Participants 21 23 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
23
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 23 participants 44 participants
27.1  (6.3) 26.5  (5.9) 26.5  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 23 participants 44 participants
Female
0
   0.0%
1
   4.3%
1
   2.3%
Male
21
 100.0%
22
  95.7%
43
  97.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 23 participants 44 participants
21 23 44
1.Primary Outcome
Title Lower Extremity Muscle Strength- Extension
Hide Description Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Time Frame 0, 3, 6, 9, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Kilograms
Residual Limb: Week 0 24.5  (10.7) 26.4  (13.4)
Residual Limb: Week 3 27.6  (12.5) 34.1  (12.7)
Residual Limb: Week 6 33.8  (17.3) 36.9  (12.6)
Residual Limb: Week 9 35.7  (14.0) 39.1  (16.5)
Residual Limb: Week 12 36.1  (15.4) 42.8  (14.8)
Intact Limb: Week 0 45.7  (23.8) 45.4  (17.6)
Intact Limb: Week 3 45.2  (24.3) 41.4  (16.1)
Intact Limb: Week 6 45.0  (19.5) 45.2  (13.7)
Intact Limb: Week 9 46.0  (16.7) 45.7  (16.1)
Intact Limb: Week 12 49.0  (20.7) 51.8  (16.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Rehabilitation Protocol, NMES Plus Standard Rehabilitation Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
2.Primary Outcome
Title Lower Extremity Muscle Strength- Flexion
Hide Description Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
Time Frame 0, 3, 6, 9, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Kilograms
Residual Limb: Week 0 14.8  (8.5) 14.2  (6.2)
Residual Limb: Week 3 14.8  (7.4) 16.7  (7.0)
Residual Limb: Week 6 16.8  (7.3) 18.7  (6.9)
Residual Limb: Week 9 18.4  (7.5) 19.9  (7.6)
Residual Limb: Week 12 19.5  (8.4) 21.8  (6.6)
Intact Limb: Week 0 25.4  (7.1) 27.8  (10.7)
Intact Limb: Week 3 27.1  (10.2) 28.7  (9.4)
Intact Limb: Week 6 26.9  (10.9) 32.2  (10.3)
Intact Limb: Week 9 28.8  (9.9) 30.9  (9.7)
Intact Limb: Week 12 28.8  (10.1) 29.4  (9.9)
3.Primary Outcome
Title Lower Extremity Mobility-Distance
Hide Description Mobility was measured by the distance walked in 2 minutes.
Time Frame 6, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: inches
Usual Pace: Week 6 5081  (2324) 4452  (1949)
Usual Pace: Week 12 5853  (2420) 5657  (1919)
Fast Pace: Week 6 7308  (2557) 6369  (2316)
Fast Pace: Week 12 8116  (2763) 7692  (2072)
4.Primary Outcome
Title Lower Extremity Mobility- Up and Go
Hide Description Mobility was measured by the time to complete an "up and go" test.
Time Frame 6, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Seconds
Week 6 7.3  (3.9) 7.7  (4.8)
Week 12 6.3  (3.5) 7.1  (4.4)
5.Primary Outcome
Title Lower Extremity Mobility- Stair Climb
Hide Description Mobility was measured by the time to complete a timed stair climb.
Time Frame 6, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Seconds
Week 6 7.8  (3.8) 7.5  (4.4)
Week 12 4.7  (3.3) 5.6  (4.0)
6.Primary Outcome
Title Lower Extremity Mobility-Chair Rise
Hide Description Mobility was measured by the number of stands during the 30-second chair rise test.
Time Frame 6, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: Number of stands
Week 6 18.1  (11.4) 15.7  (8.4)
Week 12 21.7  (9.9) 19.4  (9.2)
7.Secondary Outcome
Title Pain Severity
Hide Description Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its "worst," "least," "average," and "current" level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items.
Time Frame 0, 3, 6, 9, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 2.9  (1.5) 3.3  (1.6)
Week 3 2.6  (1.4) 2.4  (1.6)
Week 6 2.2  (1.7) 2.2  (1.4)
Week 9 2.2  (1.6) 2.6  (1.7)
Week 12 1.8  (1.6) 2.4  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Rehabilitation Protocol, NMES Plus Standard Rehabilitation Protocol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
8.Secondary Outcome
Title Pain Interference
Hide Description Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.
Time Frame 0, 3, 6, 9, 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol NMES Plus Standard Rehabilitation Protocol
Hide Arm/Group Description:
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 2.9  (2.4) 3.1  (2.4)
Week 3 2.5  (2.2) 2.2  (2.0)
Week 6 2.3  (2.6) 2.4  (2.3)
Week 9 2.0  (2.5) 2.8  (2.7)
Week 12 2.1  (2.5) 2.7  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Rehabilitation Protocol NMES w/ Rehab
Hide Arm/Group Description

The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1-week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for ~6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with the prosthetic leg and began post-prosthetic training. The training focus is lower limb prosthetic proficient in ambulation.

NMES (EMPI 300PV) plus standard of care: In addition to the standard rehabilitation, the NMES group will receive NMES to the quadriceps muscle of the residual & intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of 15-20 minute stimulation sessions with a 5-minute patient treatment log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.

The treatment group receives NMES to the quadriceps muscle of the residual & intact limb plus rehabilitation. The therapy consists of 12-weeks of NMES using the EMPI 300PV muscle stimulator. Participants train at home for 5 days/week; each session consisted of 15-20 min of NMES to each leg eliciting 15 contractions/leg (10 sec on:50 sec off), plus a 5-min tx log. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental.

NMES plus standard of care: In addition to the standard rehabilitation, the NMES treatment group will receive NMES to the quadriceps muscle of the residual & intact limb. EMPI 300PV is the NMES device. NMES training will consist of performing 15-20 minute stimulation sessions with a 5-minute patient tx log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed at home. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device.

All-Cause Mortality
Standard Rehabilitation Protocol NMES w/ Rehab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Rehabilitation Protocol NMES w/ Rehab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Rehabilitation Protocol NMES w/ Rehab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/23 (0.00%) 
The limitations of the the study was that it was not powered to detect a small or moderate difference between the two treatment groups. The sample was small and limited to military service members.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Laura Talbot
Organization: University of Tennessee Health Science Center
Phone: 901-448-3630
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT00942890     History of Changes
Other Study ID Numbers: TSNRP Grant HU0001-08-1-TS10
First Submitted: July 15, 2009
First Posted: July 21, 2009
Results First Submitted: October 11, 2016
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018