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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

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


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: TENS Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
Actual Study Start Date : September 30, 2013
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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.
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

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.
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

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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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


  11. 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 .


  12. 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

  13. 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

  14. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888640


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37262-2681
Sponsors and Collaborators
Kathleen Sluka
Vanderbilt University
Investigators
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Principal Investigator: Kathleen A Sluka, PhD, PT University of Iowa
Principal Investigator: Leslie J. Crofford, MD Vanderbilt University
  Study Documents (Full-Text)

Documents provided by Kathleen Sluka, University of Iowa:
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathleen Sluka, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01888640    
Other Study ID Numbers: 201110717
First Posted: June 28, 2013    Key Record Dates
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: By publication
Supporting Materials: Study Protocol
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.

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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
Keywords provided by Kathleen Sluka, University of Iowa:
TENS
Fibromyalgia
Accelerometer
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases