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

NCT ID: NCT04683042

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2025-03-11

Brief Summary

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS) with PT

Intervention Type: DEVICE

Use of TENS units along with routine PT therapy

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.

Group Type: OTHER

PT only

Intervention Type: OTHER

Routine PT therapy only

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) with PT

Use of TENS units along with routine PT therapy

Intervention Type: DEVICE

PT only

Routine PT therapy only

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathleen Sluka

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Sluka

Kathleen A. Sluka, PhD, PT, FAPTA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen Sluka, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Leslie Crofford, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Dana Dailey, PhD, PT

Role: STUDY_DIRECTOR

University of Iowa

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Rock Valley Physical Therapy

Moline, Illinois, United States

Kepros Physical Therapy and Performance

Cedar Rapids, Iowa, United States

Genesis Physical Therapy

Davenport, Iowa, United States

Big Stone Therapies (BST)

Big Stone City, South Dakota, United States

Advanced Physical Therapy Sport Medicine

Appleton, Wisconsin, United States

Countries

United States

References

Post AA, Dailey DL, Bayman EO, Chimenti RL, Costigan M, Franck C, Huff T, Johnson E, Koepp M, Lafontant DE, McCabe ME, Neill-Hudson T, Vance CGT, Van Gorp B, Zimmerman BM, Ecklund D, Crofford LJ, Sluka KA. The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Phys Ther. 2022 Nov 6;102(11):pzac116. doi: 10.1093/ptj/pzac116.

Reference Type: DERIVED

PMID: 36036838 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1UG3AR076387-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201909757

Identifier Type: -

Identifier Source: org_study_id