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Clinical Trials/NCT00932360
NCT00932360
Completed
Not Applicable

Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)

Dana Dailey1 site in 1 country43 target enrollmentJune 2009
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Dana Dailey
Enrollment
43
Locations
1
Primary Endpoint
Pain at Rest Difference Score Pre-intervention and Post Intervention
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
June 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Dana Dailey
Responsible Party
Sponsor Investigator
Principal Investigator

Dana Dailey

Research Associate

University of Iowa

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain at Rest Difference Score Pre-intervention and Post Intervention

Time Frame: 3 weeks

Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.

Pain With Movement Difference Score Pre-intervention and Post Intervention

Time Frame: 3 weeks

Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.

Secondary Outcomes

  • Fatigue at Rest Difference Score Pre-intervention and Post Intervention(3 weeks)
  • Fatigue With Movement Difference Score Pre-intervention and Post Intervention(3 weeks)
  • PPT Cervical Region(3 weeks)
  • PPT Lumbar Region(3 weeks)
  • PPT for Anterior Tibialis(3 weeks)
  • 6 Minute Walk Test Average Change (Feet)(3 weeks)

Study Sites (1)

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