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Sponsors and Collaborators: |
University of Iowa Orthopedic Section of the American Physical Therapy Association |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00932360 |
Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue and tenderness with hyperalgesia to pressure over tender points. Pain associated with fibromyalgia can interfere with daily function, work, and social activities. Thus, 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. Although the etiology of fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced central inhibition, and enhanced temporal summation. Reducing pain in people with fibromyalgia would help increase the patient's ability to return to work, perform activities of daily living and thus improve the quality of life for the patient. Transcutaneous electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers electrical stimulation through the skin and is used for both acute and chronic pain. TENS works by reducing central excitability and increasing central inhibition. Thus, the investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that this decrease in pain and/or central excitability will improve function. The primary aim of the study is to test the effectiveness of TENS on pain and central excitability in a crossover design study for patients with Fibromyalgia with random assignment to three treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary aim is to test the effect of decreased pain and central excitability on function in patients with Fibromyalgia.
Condition | Intervention |
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Fibromyalgia |
Device: Transient Placebo TENS (Rehabilicare Maxima TENS) Device: Active TENS (Rehabilicare Maxima TENS) Device: No TENS (Rehabilicare Maxima TENS) |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Crossover Assignment |
Official Title: | Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) |
Estimated Enrollment: | 50 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Transient Placebo: Sham Comparator |
Device: Transient Placebo TENS (Rehabilicare Maxima TENS)
Transient placebo TENS will be applied for one arm of the study
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Active TENS: Active Comparator |
Device: Active TENS (Rehabilicare Maxima TENS)
Active high frequency TENS will be use for Active TENS
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No Treatment: No Intervention |
Device: No TENS (Rehabilicare Maxima TENS)
No TENS will have a TENS unit in place but not turned on to blind the investigator and subject
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The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the order for treatments (A, B, and C) out of a bowl at the initial testing session. This will determine the order of the testing. Each subject will receive all 3 treatments in random order. The following tools will be used to measure subject characteristics (Fibromyalgia Impact Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC) and function (6 minute walk test, range of motion, sit to stand test).
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shannon M Lehman, BBA, BSW | 319-384-3052 | shannon-lehman@uiowa.edu |
Contact: Dana L Dailey, MS, BS, BA | 319-384-3052 | dana-dailey@uiowa.edu |
United States, Iowa | |
University of Iowa - College of Nursing | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Shannon M Lehman, BBA, BSW 319-384-3052 shannon-lehman@uiowa.edu | |
Principal Investigator: Dana L Dailey, MS, BS, BA | |
Sub-Investigator: Kathleen A Sluka, PhD |
Principal Investigator: | Dana L Dailey, MS,BS,BA | University of Iowa |
Study Chair: | Kathleen A Sluka, PhD | University of Iowa |
Study Chair: | Barbara Rakel, PhD | University of Iowa |
Responsible Party: | University of Iowa and Orthopedic Section of the APTA ( Dana Dailey, Prinicipal Investigator ) |
Study ID Numbers: | C9366 |
Study First Received: | June 23, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00932360 History of Changes |
Health Authority: | United States: Institutional Review Board |
Fibromyalgia Transcutaneous Electrical Nerve Stimulation (TENS) |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Nervous System Diseases Rheumatic Diseases |