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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Physical Therapy Association
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00932360
First received: June 23, 2009
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

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 Intervention
Fibromyalgia
Device: Transient Placebo TENS (Rehabilicare Maxima TENS)
Device: Active TENS (Rehabilicare Maxima TENS)
Device: No TENS (Rehabilicare Maxima TENS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Pain pressure threshold: A digital pressure Algometer (Somedic AB, Farsta, Sweden) will be used to measure pain threshold to deep mechanical stimuli. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6MWT: 6 minute walk test monitoring heart rate, oxygen saturation and blood pressure. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • DNIC: descending noxious inhibitory control Assessment of DNIC will be completed using an ice water bath at 4degrees C. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • TS: Temporal Summation Temporal summation to mechanical stimulation will be measured with a custom built device incorporating a pressure transducer and a lever with a movable weight to grade the force delivered. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Range of Motion: Range of motion of the cervical and lumbar spine will be measured using inclinometers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FTSTS: Five time sit to stand: assessed by sit to stand from chair 5 repetitions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Transient Placebo Device: Transient Placebo TENS (Rehabilicare Maxima TENS)
Transient placebo TENS will be applied for one arm of the study
Other Name: Rehabilicare Maxima TENS
Active Comparator: Active TENS Device: Active TENS (Rehabilicare Maxima TENS)
Active high frequency TENS will be use for Active TENS
Other Name: Rehabilicare Maxima TENS
No Intervention: No Treatment Device: No TENS (Rehabilicare Maxima TENS)
No TENS will have a TENS unit in place but not turned on to blind the investigator and subject
Other Name: Rehabilicare Maxima TENS

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932360

Contacts
Contact: Jen Lee 319-384-3052 slukalab@healthcare.uiowa.edu
Contact: Dana L Dailey, MS, BS, BA 319-384-3052 dana-dailey@uiowa.edu

Locations
United States, Iowa
University of Iowa - College of Nursing Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jen Lee    319-384-3052    slukalab@healthcare.uiowa.edu   
Principal Investigator: Dana L Dailey, MS, BS, BA         
Sub-Investigator: Kathleen A Sluka, PhD         
Sponsors and Collaborators
University of Iowa
American Physical Therapy Association
Investigators
Principal Investigator: Dana L Dailey, MS,BS,BA University of Iowa
Study Chair: Kathleen A Sluka, PhD University of Iowa
Study Chair: Barbara Rakel, PhD University of Iowa
  More Information

No publications provided

Responsible Party: Dana Dailey, Prinicipal Investigator, University of Iowa and Orthopedic Section of the APTA
ClinicalTrials.gov Identifier: NCT00932360     History of Changes
Other Study ID Numbers: C9366
Study First Received: June 23, 2009
Last Updated: April 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Fibromyalgia
Transcutaneous Electrical Nerve Stimulation (TENS)

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014