N/A
N=43
Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00932360 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Pain at Rest Difference Score Pre-intervention and Post Intervention — 0.38; -0.74; -0.47 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana Dailey
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain at Rest Difference Score Pre-intervention and Post Intervention |
0.38; -0.74; -0.47 | — |
| PRIMARY Pain With Movement Difference Score Pre-intervention and Post Intervention |
1.11; 0.23; 0.26 | — |
| SECONDARY Fatigue at Rest Difference Score Pre-intervention and Post Intervention |
-0.09; -0.14; 0.12 | — |
| SECONDARY Fatigue With Movement Difference Score Pre-intervention and Post Intervention |
0.94; 0.39; 0.04 | — |
| SECONDARY PPT Cervical Region |
53.15; 26.42; 19.39 | — |
| SECONDARY PPT Lumbar Region |
86.97; 34.89; 33.23 | — |
| SECONDARY PPT for Anterior Tibialis |
62.86; 38.98; 4.4 | — |
| SECONDARY 6 Minute Walk Test Average Change (Feet) |
41.85; -40.48; -0.97 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00932360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.