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TENS + Physical Therapy for Fibromyalgia (FM-TIPS Trial)

Phase 3
Recruiting
Led By Leslie Crofford, MD
Research Sponsored by Kathleen Sluka
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 until 99.
Clinician diagnosis of FM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 60 +/- 5 days home
Awards & highlights

FM-TIPS Trial Summary

This trial will test whether adding TENS to routine physical therapy improves movement-evoked pain and other symptoms in patients with fibromyalgia.

Who is the study for?
This trial is for adults aged 18-99 with fibromyalgia or chronic neck/back pain who are referred for physical therapy. Participants must be fluent in English, able to consent, and willing to use TENS. It's not suitable for those with pacemakers, recent TENS use, unstable medical conditions, allergies to gel patches, cancer treatment, epilepsy or pregnancy.Check my eligibility
What is being tested?
The study tests if adding Transcutaneous Electrical Nerve Stimulation (TENS) to regular physical therapy helps reduce movement-evoked pain in fibromyalgia patients more than just physical therapy alone. It also looks at whether TENS improves overall disease symptoms and reduces the need for medication.See study design
What are the potential side effects?
Potential side effects of using TENS may include skin irritation where the pads are placed, muscle twitching during use, and discomfort from the electrical current. Generally considered safe when used correctly; serious side effects are rare.

FM-TIPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 99 years old.
Select...
I have been diagnosed with fibromyalgia.

FM-TIPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~research homework before pt visit 3 (day 1), day 60 +/- 5 days home
This trial's timeline: 3 weeks for screening, Varies for treatment, and research homework before pt visit 3 (day 1), day 60 +/- 5 days home for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test
Secondary outcome measures
Change in the resting pain score (0 - 10 Low to High scale)
FM Disease activity (FIQR) (0-10 Low to High Scale)
Movement-evoked fatigue (NRS) (0-10 Low to High Scale)
+5 more

FM-TIPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: No TENS with PTExperimental Treatment1 Intervention
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 II: TENS with PTActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Kathleen SlukaLead Sponsor
2 Previous Clinical Trials
341 Total Patients Enrolled
1 Trials studying Fibromyalgia
301 Patients Enrolled for Fibromyalgia
Leslie Crofford, MDPrincipal InvestigatorVanderbilt University
1 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Fibromyalgia
110 Patients Enrolled for Fibromyalgia
Dana Dailey, PhD, PTStudy DirectorUniversity of Iowa

Media Library

Transcutaneous Electrical Nerve Stimulation (TENS) with PT (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04683042 — Phase 3
Fibromyalgia Research Study Groups: TENS with PT, No TENS with PT
Fibromyalgia Clinical Trial 2023: Transcutaneous Electrical Nerve Stimulation (TENS) with PT Highlights & Side Effects. Trial Name: NCT04683042 — Phase 3
Transcutaneous Electrical Nerve Stimulation (TENS) with PT (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04683042 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research only test on those under 80 years old?

"This trial is enrolling individuals who have not yet turned 99 and are of legal age."

Answered by AI

To which patients does this research project extend?

"We are looking for 600 individuals that have fibromyalgia and are between 18-99 years old to participate in this clinical trial. Additionally, it is important that patients meet the following conditions: Age 18 until 99., 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)."

Answered by AI

Could you please elaborate on the risks associated with TENS and PT therapies?

"TENS with PT has undergone multiple rounds of clinical trials, meaning that there is a fair amount of data supporting both its efficacy and safety. Consequently, our team has given it a score of 3."

Answered by AI

Does this clinical trial have a significant presence in Canada?

"So far, this research is being conducted at Advanced Physical Therapy Sport Medicine in Appleton, Wisconsin, University of Illinois at Chicago in Chicago, Illinois, and Genesis Physical Therapy in Davenport, Iowa with 6 other locations in the works."

Answered by AI

Are researchers actively looking for participants for this clinical trial?

"This clinical trial, which is seeking participants, was originally posted on 1/22/2021 and was last updated on 9/9/2022."

Answered by AI

Who else is applying?

What site did they apply to?
Advanced Physical Therapy Sport Medicine
University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
Kathleen Sluka 2021. "Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04683042.
All > Fibromyalgia Chicago > Fibromyalgia
~108 spots leftby Apr 2025
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