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

NCT ID: NCT00932360

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-06-30

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active TENS Placebo TENS No TENS

Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

Placebo TENS Active TENS No TENS

Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Participants wore a TENS unit that was turned off for blinding of the outcome assessor

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

No TENS Active TENS Placebo TENS

No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

Active TENS No TENS Placebo TENS

Active TENS: 100 Hz, 200 μs at maximal tolerable intensity No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

Placebo TENS No TENS Active TENS

Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

No TENS Placebo TENS Active TENS

No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Active TENS, Placebo TENS and No Treatment TENS

Interventions

TENS

Active TENS, Placebo TENS and No Treatment TENS

Intervention Type: DEVICE

Other Intervention Names

Rehabilicare Maxima

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Physical Therapy Association

OTHER

Sponsor Role: collaborator

Dana Dailey

OTHER

Sponsor Role: lead

Responsible Party

Dana Dailey

Research Associate

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dana L Dailey, PT,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Kathleen A Sluka, PhD

Role: STUDY_CHAIR

University of Iowa

Barbara Rakel, PhD

Role: STUDY_CHAIR

University of Iowa

Locations

University of Iowa - Physical Therapy and Rehabilitation Science

Iowa City, Iowa, United States

Countries

United States

References

Dailey DL, Rakel BA, Vance CGT, 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):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.

Reference Type: RESULT

PMID: 23900134 (View on PubMed)

Related Links

https://www-ncbi-nlm-nih-gov.proxy.lib.uiowa.edu/pmc/articles/PMC3972497/

PubMed Link for full text article

Other Identifiers

200903744

Identifier Type: -

Identifier Source: org_study_id

NCT00750321

Identifier Type: -

Identifier Source: nct_alias