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NCT Number: NCT00932360

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa - Physical Therapy and Rehabilitation Science

Iowa City, Iowa, 52242, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

Active TENS, Placebo TENS and No Treatment TENS

Other names: Rehabilicare Maxima

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana Dailey

Other

Collaborators

  • American Physical Therapy Association

Registry information

Acronym: TENS&FM

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2009
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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