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NCT Number: NCT01888640

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

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 names: Empi Select Unit

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kathleen Sluka

Other

Collaborators

  • Vanderbilt University

Registry information

Official study title

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

Acronym: FAST

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2013
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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