Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial

June 1, 2023 updated by: Kathleen Sluka

The purpose of this study is to determine if addition of Transcutaneous Electrical Nerve Stimulation (TENS) to routine physical therapy improves movement-evoked pain in patients with fibromyalgia (FM).

The study will also determine if addition of TENS to routine physical therapy (PT) improves disease activity and symptoms, increases adherence to physical therapy, increases the likelihood of meeting patient specific functional goals, and reduces medication use.

Study Overview

Detailed Description

This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by healthcare system and facility size. Sites will be randomized to enroll all eligible and consented participants with FM to TENS with PT, or PT only (no TENS). We are identifying 25-35 clinics across 6 healthcare systems in both rural and urban settings. We will enroll 450 patients that self report a clinician diagnosis of FM. At each site, TENS (or no TENS) will be applied during each visit along with individualized PT treatment specified by the physical therapist. Participants randomized to TENS intervention sites will receive TENS units and electrodes at baseline to be applied to the cervical and lumbar regions. Participants will take the units home and bring the units back to their PT clinic visits with instructions for use at home while active and during their exercises. The physical therapist at each clinic will complete routine documentation of treatment. In addition to the primary and secondary outcomes, Electronic Health Record data variables will be collected as exploratory outcomes. Variables including adherence to treatment will be extracted from each site's Electronic Health Record. Patient-reported assessments will be obtained from the participant's at home the day of their second PT visit (Baseline) and at 30, 60 (primary outcome), 90, and 180 days following enrollment. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.

Participants will be identified after they are referred for PT for treatment of primary fibromyalgia (FM) or chronic pain (pain lasting more than three months). At their first (intake) physical therapy visit, they will be provided information about the study that can be accessed on paper or on-line. They will perform an electronic screening form on the first visit if interested in participating. Participants will provide e-consent after eligibility is confirmed at the initial PT visit. At the second PT visit after e-consent is signed, participants will be provided instructions on logging onto REDCap for data capture and accessing the case report forms. Participants enrolled at a TENS site will then be instructed in use of TENS and the TENS unit with electrodes will be provided. Those participants enrolled at a no TENS site will skip the instruction in use of TENS but will then receive instructions along with the TENS units at day 65. Participants will be instructed to capture all baseline assessments at home before their next PT visit before and following their first TENS treatment (or no TENS) at home (day 1). At 30, 60, 90, and 180 days following enrollment, participants will complete the same assessments at home including pain ratings at rest and with movement along with questionnaires. The primary and secondary outcome assessments will be comparing TENS and no TENS groups in terms of changes from baseline to 60 days.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois at Chicago
      • Moline, Illinois, United States, 61265
        • Recruiting
        • Rock Valley Physical Therapy
    • Iowa
      • Cedar Rapids, Iowa, United States, 52404
        • Recruiting
        • Kepros Physical Therapy and Performance
      • Davenport, Iowa, United States, 52807
        • Active, not recruiting
        • Genesis Physical Therapy
    • South Dakota
      • Big Stone City, South Dakota, United States, 57216
        • Recruiting
        • Big Stone Therapies (BST)
    • Wisconsin
      • Appleton, Wisconsin, United States, 54913
        • Recruiting
        • Advanced Physical Therapy Sport Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 until 99.
  2. Clinician diagnosis of FM
  3. Referred for land-based PT
  4. Referred for treatment for FM or chronic pain (pain lasting more than 3 months)
  5. Able to provide informed consent.
  6. Fluent in reading English
  7. Willing to use TENS

Exclusion Criteria:

  1. Contraindications to TENS use including:

    1. Pacemaker, defibrillator, implanted neurostimulator or implanted device
    2. Epilepsy
    3. Currently pregnant or plan to become pregnant in the next 6 months
    4. Allergic reaction to patches with gel
    5. Current treatment for cancer
  2. Currently enrolled in another pain control study
  3. Use of TENS within the last 30 days
  4. Clinically unstable medical or psychiatric issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS with PT
TENS with PT group: The TENS with PT group will receive usual PT care and following enrollment, during the second PT visit, participants will receive TENS units and instruction on use of the TENS units. TENS will be applied to the upper and lower back with butterfly electrodes using the following parameters: mixed frequency (2-125Hz), strong but comfortable intensity, variable pulse duration from 100-250 microseconds. TENS to be applied when the patient is active and doing exercises at home and during PT sessions for 30 minutes at least 2 hours per day. The TENS with PT group will complete TENS use to the end of the study at 6 months.
Use of TENS units along with routine PT therapy
Other: No TENS with PT
The No TENS group will receive usual PT care until the primary endpoint timeframe of 60 days. After completion of the research homework at 60 days, TENS units will be mailed to the participants and a study team member will complete virtual TENS instruction. The no TENS group will complete TENS to the end of the study at 6 months.
Routine PT therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Numeric rating scale of 0-10 for reduction of movement-evoked pain measured by 11-point NRS from baseline to 60 days.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the resting pain score (0 - 10 Low to High scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
The severity of pain will be measured on a 0 to 10 numeric rating scale where 0 is no-pain and 10 is worst pain imaginable.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Pain interference (BPI) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
11 items measuring pain severity and interference with daily activities on a 0-10 scale.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
FM Disease activity (FIQR) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Resting fatigue (NRS) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
The severity of fatigue will be measured with a 0 to 10 scale where 0 is no fatigue and 10 is worst fatigue imaginable.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Movement-evoked fatigue (NRS) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Fatigue during a five times sit and stand test will be measured with a 0 to 10 numeric rating scale with 0 as no fatigue and 10 as the worst fatigue imaginable.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Multidimensional assessment of fatigue (MAF) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
16 items measuring fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and impact on various activities of daily living.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Rapid assessment of physical activity (RAPA) (0-10 Low to High Scale)
Time Frame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
9 items evaluating current level of physical activity.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Patient global impression of change (PGIC) (0-6 Scale)
Time Frame: Day 60 +/- 5 days Home
Evaluates overall health status as perceived by the patient in a seven-point single-item scale ranging from 'very much worse' to 'very much improved'
Day 60 +/- 5 days Home

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Kathleen Sluka, PhD, PT, University of Iowa
  • Principal Investigator: Leslie Crofford, MD, Vanderbilt University
  • Study Director: Dana Dailey, PhD, PT, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The current study is expected to generate patient-reported outcomes for individuals with fibromyalgia across a broad spectrum of domains, pain, fatigue, function, psychological factors, and quality of life. We will also collect some data from the electronic health record about number of physical therapy visits, Current Protocol Terminology (CPT) codes for treatments, and the patient-specific functional scale. In addition, we will have TENS usage data downloaded from the TENS devices that will show the number of minutes of TENS use and the number of 30 minute sessions completed. Data will be collected prior to the intervention (baseline data) and 30, 60, 90 and 180 days after enrollment.

IPD Sharing Time Frame

Analysis datasets will be made available at the time of publication of the primary manuscript. Complete datasets and accompanying resources will be deposited to the designated NIH Helping to End Addiction Long-term initiative (HEAL) data repository after the completion of the primary aim manuscript.

IPD Sharing Access Criteria

In accordance with NIH Collaboratory policies, we will prepare the primary analysis datasets (at a minimum) for submission to the Collaboratory Coordinating Center. In accordance with International Committee of Medical Journal Editors (ICMJE) policies, we will prepare the primary analysis datasets for review and reproducibility by peer-reviewed journals. We will prepare the final datasets and accompanying resource documents for final deposit to the designated NIH HEAL data repository.

Publications will be made available to the public using open access publishing, so they become available immediately to the public. All publications will be accessible through PubMED, google scholar, and available to the public through open access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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