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

Fibromyalgia Clinical Trial

— TENS&FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932360
• Other study ID #: 200903744
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00750321

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• TENS
Active TENS, Placebo TENS and No Treatment TENS

Locations

Country	Name	City	State
United States	University of Iowa - Physical Therapy and Rehabilitation Science	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Dana Dailey	American Physical Therapy Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dailey DL, Rakel BA, Vance CG, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at Rest Difference Score Pre-intervention and Post Intervention	Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.	3 weeks
Primary	Pain With Movement Difference Score Pre-intervention and Post Intervention	Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.	3 weeks
Secondary	Fatigue at Rest Difference Score Pre-intervention and Post Intervention	Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.	3 weeks
Secondary	Fatigue With Movement Difference Score Pre-intervention and Post Intervention	Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.	3 weeks
Secondary	PPT Cervical Region	Pressure pain threshold cervical region (kPa)	3 weeks
Secondary	PPT Lumbar Region	Pressure pain threshold in lumbar region (kPa)	3 weeks
Secondary	PPT for Anterior Tibialis	Pressure pain threshold in leg (kPa)	3 weeks
Secondary	6 Minute Walk Test Average Change (Feet)	6 minute walk test average change (feet) before and after intervention	3 weeks

External Links

•   PubMed Link for full text article