View Clinical Trial (Medical Research Study)
Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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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.
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| Study Summary: |
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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).
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| Criteria: |
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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
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| NCT ID: |
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NCT00932360 |
| Primary Contact: |
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Principal Investigator
Dana L Dailey, MS,BS,BA
University of Iowa
Jen Lee
Phone: 319-384-3052
Email: slukalab@healthcare.uiowa.edu
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| Backup Contact: |
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Email: dana-dailey@uiowa.edu
Dana L Dailey, MS, BS, BA
Phone: 319-384-3052
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| Location Contact: |
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Iowa City, Iowa 52242
United States
Jen Lee
Phone: 319-384-3052
Email: slukalab@healthcare.uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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