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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932360
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : January 10, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
American Physical Therapy Association
Information provided by (Responsible Party):
Dana Dailey, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: TENS Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
Study Start Date : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima

Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima

Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima

Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima

Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima

Experimental: 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
Device: TENS
Active TENS, Placebo TENS and No Treatment TENS
Other Name: Rehabilicare Maxima




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Fatigue at Rest Difference Score Pre-intervention and Post Intervention [ Time Frame: 3 weeks ]
    Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.

  2. Fatigue With Movement Difference Score Pre-intervention and Post Intervention [ Time Frame: 3 weeks ]
    Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.

  3. PPT Cervical Region [ Time Frame: 3 weeks ]
    Pressure pain threshold cervical region (kPa)

  4. PPT Lumbar Region [ Time Frame: 3 weeks ]
    Pressure pain threshold in lumbar region (kPa)

  5. PPT for Anterior Tibialis [ Time Frame: 3 weeks ]
    Pressure pain threshold in leg (kPa)

  6. 6 Minute Walk Test Average Change (Feet) [ Time Frame: 3 weeks ]
    6 minute walk test average change (feet) before and after intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932360


Locations
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United States, Iowa
University of Iowa - Physical Therapy and Rehabilitation Science
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Dana Dailey
American Physical Therapy Association
Investigators
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Principal Investigator: Dana L Dailey, PT,PhD University of Iowa
Study Chair: Kathleen A Sluka, PhD University of Iowa
Study Chair: Barbara Rakel, PhD University of Iowa
Additional Information:
Publications of Results:
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Responsible Party: Dana Dailey, Research Associate, University of Iowa
ClinicalTrials.gov Identifier: NCT00932360    
Obsolete Identifiers: NCT00750321
Other Study ID Numbers: 200903744
First Posted: July 3, 2009    Key Record Dates
Results First Posted: January 10, 2019
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: See Publication listed for data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dana Dailey, University of Iowa:
Fibromyalgia
Transcutaneous Electrical Nerve Stimulation (TENS)
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases