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Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, and stiffness associated with fatigue and sleep disturbance. The goal of reducing opioid use in patients with chronic pain requires that proven non-pharmacological treatments are applied in clinical practice. The study team has recently completed the FAST (Fibromyalgia Activity Study with TENS) trial demonstrating the efficacy of Active Transcutaneous Electrical Nerve Stimulation (TENS) compared with Placebo TENS or No Treatment in women with FM.  While physical therapists are trained in the use of TENS, it is underused in clinical practice. This study proposes to conduct an embedded pragmatic trial to compare the effectiveness of physical therapy with or without the addition of TENS for FM patients within physical therapy (PT) practices as the study sites.

The overall goal of this proposal is to (1) demonstrate the feasibility of adding TENS to the treatment of patients with FM in a real-world PT practice setting and (2) to determine if the addition of TENS to PT reduces pain, increases adherence to PT and allows patients with FM to reach their specific functional goals with less drug use. The study team hypothesizes that using TENS in a PT setting is feasible and that FM patients using TENS are more likely to reach their therapeutic goals and reduce medication use.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:             18 Years to 99 Years   (Adult, Older Adult)

Sexes Eligible for Study:           All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • Age 18 until 99.
  • Clinician diagnosis of FM
  • Referred for land-based PT
  • Referred for treatment of FM, chronic neck pain (has secondary FM diagnosis) or chronic back pain (has secondary FM diagnosis)
  • Able to provide informed consent.
  • Fluent in reading English
  • Willing to use TENS

 

Exclusion Criteria:

  • Contraindications to TENS use including:
    • Pacemaker, defibrillator, implanted neurostimulator or implanted device
    • Epilepsy
    • Currently pregnant or plan to become pregnant in the next 6 months
    • Allergic reaction to patches with gel
    • Current treatment for cancer
  • Currently enrolled in another pain control study
  • Use of TENS within the last 6 months
  • Clinically unstable medical or psychiatric issues

Study Design:

Allocation:       Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Study Location(s):

University of Illinois at Chicago, Chicago, Illinois, United States, 60607

Rock Valley Physical Therapy, Moline, Illinois, United States, 61265

Kepros Physical Therapy and Performance, Cedar Rapids, Iowa, United States, 52404

Genesis Physical Therapy, Davenport, Iowa, United States, 52807

Advanced Physical Therapy Sport Medicine, Appleton, Wisconsin, United States, 54913

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04683042?term=NCT04683042&draw=2&rank=1

 

Last Updated: June 2021