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

NCT00932360 | Completed Results DMC FDA Device

• 1 other identifier: 200903744
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Transcutaneous Electrical Nerve Stimulation (TENS)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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

Study Arms (6)

Active TENS Placebo TENS No TENS

EXPERIMENTAL

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

Device: TENS

Placebo TENS Active TENS No TENS

EXPERIMENTAL

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

Device: TENS

No TENS Active TENS Placebo TENS

EXPERIMENTAL

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

Device: TENS

Active TENS No TENS Placebo TENS

EXPERIMENTAL

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

Device: TENS

Placebo TENS No TENS Active TENS

EXPERIMENTAL

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

Device: TENS

No TENS Placebo TENS Active TENS

EXPERIMENTAL

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

Device: TENS

Interventions

TENS DEVICE

Active TENS, Placebo TENS and No Treatment TENS

Also known as: Rehabilicare Maxima

Active TENS No TENS Placebo TENS; Active TENS Placebo TENS No TENS; No TENS Active TENS Placebo TENS; No TENS Placebo TENS Active TENS; Placebo TENS Active TENS No TENS; Placebo TENS No TENS Active TENS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia diagnosis by a physician
• History of cervical or lumbar pain

You may not qualify if:

• TENS use in the last 5 years
• Pacemaker
• No use of opioids

Sponsors & Collaborators

• Dana Dailey: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

University of Iowa - Physical Therapy and Rehabilitation Science

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 23900134 RESULT

Related Links

• PubMed Link for full text article

MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

43 subjects were enrolled to the study and completed a treatment (Active TENS, Placebo TENS or No TENS) in a randomized order with a one week washout period between treatments. Results were analyzed by comparing the groups for outcome measures.

Results Point of Contact

• Title: Dana Dailey
• Organization: University of Iowa

dana-dailey@uiowa.edu

319-335-7149

Study Officials

• Dana L Dailey, PT,PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Kathleen A Sluka, PhD

  University of Iowa

  STUDY CHAIR

• Barbara Rakel, PhD

  University of Iowa

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: July 3, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 16, 2019
• Results First Posted: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)