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

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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

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 28, 2013
Results First Submitted Date  ICMJE June 24, 2019
Results First Posted Date  ICMJE October 31, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE September 30, 2013
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS ]
    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
  • Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Aim #1: Pain with movement [ Time Frame: change from pre and post TENS treatment within treatment sessions 2,3,4 ]
The primary aim of the study is to test the effect of the long-term use of TENS on movement-related pain as measured by a numeric rating scale (NRS) during six minute walk test (6MWT) in women with fibromyalgia with random assignment to three treatments: standard care (No TENS), placebo TENS and active TENS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Resting Pain (0-10 Low to High Scale) [ Time Frame: Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS) ]
    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
  • Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Resting Fatigue Rating (0-10 Low to High Scale) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Fibromyalgia Impact Questionnaire Revised [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Brief Pain Inventory - Interference (0-10 Low to High Scale) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Brief Pain Inventory, Intensity (0-10 Low to High Scale) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Tampa Scale of Kinesiophobia (17 to 68 Low to High) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Short Form Survey 36; Mental Component Score (T Score Mean of 50) [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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 .
  • Six Minute Walk Test [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Five Time Sit to Stand Test Rate Per 10 Seconds [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
  • Moderate Vigorous Physical Activity Minutes Per Day [ Time Frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS) ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Aim #2: Function and quality of life [ Time Frame: Change from from baseline to session 4: 9 weeks ]
    A secondary aim will test if movement-pain reduction by TENS results in a concomitant decrease in fear of movement, fatigue, resting pain and analgesic medication and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, self-report (IPAQ), as well as performing specific function tasks. A sub-analysis will determine responders and non-responders to TENS and factors that predict both responders and non-responders. Multiple factors that could contribute to TENS response include self-efficacy, pain catastrophizing, levels of physical activity, fear of movement, sleep, pain, fatigue, function, quality of life, or pain physiology.
  • Aim #3: Pressure pain threshold and conditioned pain modulation [ Time Frame: Baseline to session 4; 9 weeks ]
    Measurement of pressure pain threshold in the neck, low back and lower extremity before and after TENS; conditioned pain modulation with a cold water bath and pressure pain threshold to the lower back and lower extremity.
  • Aim #4: PROMIS modules comparison to validated outcomes [ Time Frame: Baseline to Session 4; 9 weeks ]
    PROMIS (National Institute of Health's patient reported outcome measurement information system) results will be compared to other validated patient outcomes to determine if PROMIS is a useful instrument to describe the experience of women with fibromyalgia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Official Title  ICMJE Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
Brief Summary

Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Transcutaneous electrical nerve stimulation is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.

Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life

Detailed Description

This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a non-pharmacological agent which delivers electrical stimulation by a battery operated device via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and non-invasive modality used to treat a variety of acute and chronic pain conditions. The initial phase of the study will randomly allocate subjects to receive active TENS, placebo TENS or standard care (No TENS). After participating in the 1 month random assignment, all subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional tasks, accelerometry, TENS, pain and fatigue assessments.

Study Aims:

Aim #1: The primary aim of the study is to test the effectiveness of repeated TENS use on movement-related pain in people with fibromyalgia with random assignment to three treatments: standard care, placebo TENS and active Aim #2: A secondary aim will test if pain reduction by TENs results in a concomitant decrease in fatigue and fear of movement, and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, as well as performing specific functional tasks

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Device: 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 No TENS - Standard Care

Other Name: Empi Select Unit
Study Arms  ICMJE
  • Active Comparator: ActiveTENS
    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.
    Intervention: Device: TENS
  • Placebo Comparator: Placebo 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.
    Intervention: Device: TENS
  • No Intervention: No TENS (Standard Care)
    Participants 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
301
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
360
Actual Study Completion Date  ICMJE April 2, 2018
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants will be 18 to 70 years of age
  • Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male.
  • Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
  • History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis)
  • Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months.
  • English speaking

Exclusion Criteria:

  • Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study.
  • TENS use in the last 5 years
  • Pacemaker
  • Uncontrolled blood pressure or diabetes
  • Neuropathic pain condition
  • Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
  • Spinal fusion - cervical or lumbar
  • Metal implants in cervical or lumbar region
  • Severe skin allergy to adhesive
  • Allergy to nickel
  • Pain level less than 4
  • Pregnancy
  • Epilepsy
  • Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan
  • Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888640
Other Study ID Numbers  ICMJE 201110717
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: By publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be made available by publication by April 2019 and for one year after closeout of the study and upon request with a proposed study protocol for 5 years.
Responsible Party Kathleen Sluka, University of Iowa
Study Sponsor  ICMJE Kathleen Sluka
Collaborators  ICMJE Vanderbilt University
Investigators  ICMJE
Principal Investigator: Kathleen A Sluka, PhD, PT University of Iowa
Principal Investigator: Leslie J. Crofford, MD Vanderbilt University
PRS Account University of Iowa
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP