Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Iowa
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Kathleen Sluka, University of Iowa
ClinicalTrials.gov Identifier:
NCT01888640
First received: June 13, 2013
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, 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. Transcutaneous electrical nerve stimulation is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.

Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life


Condition Intervention Phase
Fibromyalgia
Device: TENS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Aim #1: Pain with movement [ Time Frame: change from pre and post TENS treatment within treatment sessions 2,3,4 ] [ Designated as safety issue: No ]
    The primary aim of the study is to test the effect of the long-term use of TENS on movement-related pain as measured by a numeric rating scale (NRS) during six minute walk test (6MWT) in women with fibromyalgia with random assignment to three treatments: standard care (No TENS), placebo TENS and active TENS.


Secondary Outcome Measures:
  • Aim #2: Function and quality of life [ Time Frame: Change from from baseline to session 4: 9 weeks ] [ Designated as safety issue: No ]
    A secondary aim will test if movement-pain reduction by TENS results in a concomitant decrease in fear of movement, fatigue, resting pain and analgesic medication and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, self-report (IPAQ), as well as performing specific function tasks. A sub-analysis will determine responders and non-responders to TENS and factors that predict both responders and non-responders. Multiple factors that could contribute to TENS response include self-efficacy, pain catastrophizing, levels of physical activity, fear of movement, sleep, pain, fatigue, function, quality of life, or pain physiology.

  • Aim #3: Pressure pain threshold [ Time Frame: Baseline to session 4; 9 weeks ] [ Designated as safety issue: No ]
    Measurement of pressure pain threshold in the neck, low back and lower extremity before and after TENS;

  • Aim #4: PROMIS modules comparison to validated outcomes [ Time Frame: Baseline to Session 4; 9 weeks ] [ Designated as safety issue: No ]
    PROMIS (National Institute of Health's patient reported outcome measurement information system) results will be compared to other validated patient outcomes to determine if PROMIS is a useful instrument to describe the experience of women with fibromyalgia.


Estimated Enrollment: 360
Study Start Date: May 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo TENS
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
Device: TENS

TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Other Name: Empi Select Unit
No Intervention: Standard Care
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
Active Comparator: Active TENS
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
Device: TENS

TENS Parameters: Active TENS and Placebo TENS

  • TENS Frequency - 10 to100 Hz
  • TENS Pulse Width - 200 µs
  • TENS Intensity - Maximal tolerable intensity
  • Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
  • Administration - Daily
  • TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.

Placebo TENS Unit Active TENS unit Stand Care - no TENS

Other Name: Empi Select Unit

Detailed Description:

This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a non-pharmacological agent which delivers electrical stimulation by a battery operated device via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and non-invasive modality used to treat a variety of acute and chronic pain conditions. The initial phase of the study will randomly allocate subjects to receive active TENS, placebo TENS or standard care (No TENS). After participating in the 1 month random assignment, all subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional tasks, accelerometry, TENS, pain and fatigue assessments.

Study Aims:

Aim #1: The primary aim of the study is to test the effect of the long-term use of TENS on movement-related pain as measured by a numeric rating scale (NRS) during six minute walk test (6MWT) in women with fibromyalgia with random assignment to three treatments: standard care (No TENS), placebo TENS and active TENS.

Aim #2: A secondary aim will test if movement-pain reduction by TENS results in a concomitant decrease in fear of movement, fatigue, resting pain and analgesic medication and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, self-report (IPAQ), as well as performing specific function tasks. A sub-analysis will determine responders and non-responders to TENS and factors that predict both responders and non-responders. Multiple factors that could contribute to TENS response include self-efficacy, pain catastrophizing, levels of physical activity, fear of movement, sleep, pain, fatigue, function, quality of life, or pain physiology.

Aim #3: To determine if active TENS alters pain processing in women with fibromyalgia and if improvement in clinical symptoms correlates with normalization of pain processing physiology. We will evaluate change in these physiologic parameters in responders versus non-responders as assessed clinically.Pain processing will be assessed by examining pressure pain thresholds at the site and outside the site of stimulation and by examining conditioned pain modulation

Aim #4: To determine if PROMIS (patient reported outcome measurement information system) is a useful instrument for assessing outcomes in women with fibromyalgia by comparing the PROMIS modules to symptom domains measured by other instruments validated for use in fibromyalgia clinical trials and by determining the performance of PROMIS in the definition of responders.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be 18 to 70 years of age
  • Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male.
  • Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
  • History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis)
  • Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months.
  • English speaking

Exclusion Criteria:

  • Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study.
  • TENS use in the last 5 years
  • Pacemaker
  • Uncontrolled blood pressure or diabetes
  • Neuropathic pain condition
  • Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
  • Spinal fusion - cervical or lumbar
  • Metal implants in cervical or lumbar region
  • Severe skin allergy to adhesive
  • Allergy to nickel
  • Pain level less than 4
  • Pregnancy
  • Epilepsy
  • Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan
  • Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results
  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: NCT01888640

Contacts
Contact: Kathleen A Sluka, PT, PhD 319-335-9791 slukalab@uiowa.edu
Contact: Dana L Dailey, PT, PhD 319-335-7149 slukalab@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Dana L Dailey, PT, PhD    319-335-7149    slukalab@uiowa.edu   
Contact: Carol GT Vance, PT, PhD    319-335-9791    slukalab@uiowa.edu   
Sub-Investigator: Barbara A Rakel, PhD, RN         
Principal Investigator: Kathleen A. Sluka, PhD, PT         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37262-2681
Contact: Leslie Crofford, MD    615-322-4746    leslie.j.crofford@vanderbilt.edu   
Principal Investigator: Leslie J Crofford, MD         
Sponsors and Collaborators
University of Iowa
Vanderbilt University
Investigators
Principal Investigator: Kathleen A Sluka, PhD, PT University of Iowa
Principal Investigator: Leslie J. Crofford, MD Vanderbilt University
  More Information

Additional Information:
Publications:

Responsible Party: Kathleen Sluka, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01888640     History of Changes
Other Study ID Numbers: UM01-FAST2012
Study First Received: June 13, 2013
Last Updated: July 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
TENS
Fibromyalgia
Accelerometer

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 August 28, 2014