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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683042
• Other study ID #: 201909757
• Status: Recruiting
• Phase: Phase 3
• Start date: January 22, 2021
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Michele Costigan, RN
• Phone: 319.467.4203
• Email: fmtips-studyteam[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation (TENS) with PT
Use of TENS units along with routine PT therapy

Other:
• PT only
Routine PT therapy only

Locations

Country	Name	City	State
United States	Advanced Physical Therapy Sport Medicine	Appleton	Wisconsin
United States	Big Stone Therapies (BST)	Big Stone City	South Dakota
United States	Kepros Physical Therapy and Performance	Cedar Rapids	Iowa
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Genesis Physical Therapy	Davenport	Iowa
United States	Rock Valley Physical Therapy	Moline	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Kathleen Sluka

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test	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	Change in the resting pain score (0 - 10 Low to High scale)	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
Secondary	Pain interference (BPI) (0-10 Low to High Scale)	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
Secondary	FM Disease activity (FIQR) (0-10 Low to High Scale)	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
Secondary	Resting fatigue (NRS) (0-10 Low to High Scale)	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
Secondary	Movement-evoked fatigue (NRS) (0-10 Low to High Scale)	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
Secondary	Multidimensional assessment of fatigue (MAF) (0-10 Low to High Scale)	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
Secondary	Rapid assessment of physical activity (RAPA) (0-10 Low to High Scale)	9 items evaluating current level of physical activity.	Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Secondary	Patient global impression of change (PGIC) (0-6 Scale)	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