Clinical trial NCT04683042: Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
Official title: Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Transcutaneous Electrical Nerve Stimulation (TENS)
chronic pain
fibromyalgia
movement pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by facility 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 have identified 25-35 clinics across 6 healthcare systems in both rural and urban settings.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Secondary outcomes:
measure: Change in the resting pain score (0 - 10 Low to High scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Pain interference (BPI) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: FM Disease activity (FIQR) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Resting fatigue (NRS) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Movement-evoked fatigue (NRS) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Multidimensional assessment of fatigue (MAF) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Rapid assessment of physical activity (RAPA) (0-10 Low to High Scale)
timeFrame: Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
measure: Patient global impression of change (PGIC) (0-6 Scale)
timeFrame: Day 60 +/- 5 days Home
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Moline
country: United States
facility: Rock Valley Physical Therapy
state: Illinois
city: Cedar Rapids
country: United States
facility: Kepros Physical Therapy and Performance
state: Iowa
city: Davenport
country: United States
facility: Genesis Physical Therapy
state: Iowa
city: Big Stone City
country: United States
facility: Big Stone Therapies (BST)
state: South Dakota
city: Appleton
country: United States
facility: Advanced Physical Therapy Sport Medicine
state: Wisconsin
Study officials:
affiliation: University of Iowa
name: Kathleen Sluka, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Leslie Crofford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Dana Dailey, PhD, PT
role: STUDY_DIRECTOR
References: