Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) (TENS&FM)
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) |
- Pain pressure threshold: A digital pressure Algometer (Somedic AB, Farsta, Sweden) will be used to measure pain threshold to deep mechanical stimuli. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- 6MWT: 6 minute walk test monitoring heart rate, oxygen saturation and blood pressure. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- DNIC: descending noxious inhibitory control Assessment of DNIC will be completed using an ice water bath at 4degrees C. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- TS: Temporal Summation Temporal summation to mechanical stimulation will be measured with a custom built device incorporating a pressure transducer and a lever with a movable weight to grade the force delivered. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Range of Motion: Range of motion of the cervical and lumbar spine will be measured using inclinometers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- FTSTS: Five time sit to stand: assessed by sit to stand from chair 5 repetitions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Sham Comparator: Transient Placebo |
Device: Transient Placebo TENS (Rehabilicare Maxima TENS)
Transient placebo TENS will be applied for one arm of the study
Other Name: Rehabilicare Maxima TENS
|
| Active Comparator: Active TENS |
Device: Active TENS (Rehabilicare Maxima TENS)
Active high frequency TENS will be use for Active TENS
Other Name: Rehabilicare Maxima TENS
|
| No Intervention: No Treatment |
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
Other Name: Rehabilicare Maxima TENS
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Fibromyalgia diagnosis by a physician
- History of cervical or lumbar pain
Exclusion Criteria:
- TENS use in the last 5 years
- Pacemaker
- No use of opioids
Contacts and Locations| Contact: Jen Lee | 319-384-3052 | slukalab@healthcare.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: Jen Lee 319-384-3052 slukalab@healthcare.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 |
More Information
No publications provided
| Responsible Party: | Dana Dailey, Prinicipal Investigator, University of Iowa and Orthopedic Section of the APTA |
| ClinicalTrials.gov Identifier: | NCT00932360 History of Changes |
| Other Study ID Numbers: | C9366 |
| Study First Received: | June 23, 2009 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Fibromyalgia Transcutaneous Electrical Nerve Stimulation (TENS) |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013