Clinical trial NCT01888640: Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Official title: Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: TENS
Fibromyalgia
Accelerometer
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2013-06-28
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
measure: Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Secondary outcomes:
measure: Resting Pain (0-10 Low to High Scale)
timeFrame: Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
measure: Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Resting Fatigue Rating (0-10 Low to High Scale)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Fibromyalgia Impact Questionnaire Revised
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Brief Pain Inventory - Interference (0-10 Low to High Scale)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Brief Pain Inventory, Intensity (0-10 Low to High Scale)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Tampa Scale of Kinesiophobia (17 to 68 Low to High)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Short Form Survey 36; Mental Component Score (T Score Mean of 50)
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Six Minute Walk Test
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Five Time Sit to Stand Test Rate Per 10 Seconds
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
measure: Moderate Vigorous Physical Activity Minutes Per Day
timeFrame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of Iowa
name: Kathleen A Sluka, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Leslie J. Crofford, MD
role: PRINCIPAL_INVESTIGATOR
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