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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (TENS) with PT
PT only
Sponsored by
Kathleen Sluka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Transcutaneous Electrical Nerve Stimulation (TENS), chronic pain, fibromyalgia, movement pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 until 99.
  2. Clinician diagnosis of FM
  3. Referred for land-based PT
  4. Referred for treatment of FM, chronic neck pain (has secondary FM diagnosis) or chronic back pain (has secondary FM diagnosis)
  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

Sites / Locations

  • University of Illinois at ChicagoRecruiting
  • Rock Valley Physical TherapyRecruiting
  • Kepros Physical Therapy and PerformanceRecruiting
  • Genesis Physical Therapy
  • Big Stone Therapies (BST)Recruiting
  • Advanced Physical Therapy Sport MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

TENS with PT

No TENS with PT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Pain interference (BPI) (0-10 Low to High Scale)
11 items measuring pain severity and interference with daily activities on a 0-10 scale.
FM Disease activity (FIQR) (0-10 Low to High Scale)
21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
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.
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.
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.
Rapid assessment of physical activity (RAPA) (0-10 Low to High Scale)
9 items evaluating current level of physical activity.
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'

Full Information

First Posted
December 22, 2020
Last Updated
June 1, 2023
Sponsor
Kathleen Sluka
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1. Study Identification

Unique Protocol Identification Number
NCT04683042
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Sluka

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Transcutaneous Electrical Nerve Stimulation (TENS), chronic pain, fibromyalgia, movement pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS with PT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No TENS with PT
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS) with PT
Intervention Description
Use of TENS units along with routine PT therapy
Intervention Type
Other
Intervention Name(s)
PT only
Intervention Description
Routine PT therapy only
Primary Outcome Measure Information:
Title
Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test
Description
Numeric rating scale of 0-10 for reduction of movement-evoked pain measured by 11-point NRS from baseline to 60 days.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Secondary Outcome Measure Information:
Title
Change in the resting pain score (0 - 10 Low to High scale)
Description
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.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Pain interference (BPI) (0-10 Low to High Scale)
Description
11 items measuring pain severity and interference with daily activities on a 0-10 scale.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
FM Disease activity (FIQR) (0-10 Low to High Scale)
Description
21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Resting fatigue (NRS) (0-10 Low to High Scale)
Description
The severity of fatigue will be measured with a 0 to 10 scale where 0 is no fatigue and 10 is worst fatigue imaginable.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Movement-evoked fatigue (NRS) (0-10 Low to High Scale)
Description
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.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Multidimensional assessment of fatigue (MAF) (0-10 Low to High Scale)
Description
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.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Rapid assessment of physical activity (RAPA) (0-10 Low to High Scale)
Description
9 items evaluating current level of physical activity.
Time Frame
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Title
Patient global impression of change (PGIC) (0-6 Scale)
Description
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'
Time Frame
Day 60 +/- 5 days Home

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 until 99. Clinician diagnosis of FM Referred for land-based PT Referred for treatment for FM or chronic pain (pain lasting more than 3 months) Able to provide informed consent. Fluent in reading English Willing to use TENS Exclusion Criteria: Contraindications to TENS use including: Pacemaker, defibrillator, implanted neurostimulator or implanted device Epilepsy Currently pregnant or plan to become pregnant in the next 6 months Allergic reaction to patches with gel Current treatment for cancer Currently enrolled in another pain control study Use of TENS within the last 30 days Clinically unstable medical or psychiatric issues
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Costigan, RN
Phone
319.467.4203
Email
fmtips-studyteam@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Johnson, PhD
Phone
319.467.4203
Email
fmtips-studyteam@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Sluka, PhD, PT
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie Crofford, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Dailey, PhD, PT
Organizational Affiliation
University of Iowa
Official's Role
Study Director
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
Rock Valley Physical Therapy
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Individual Site Status
Recruiting
Facility Name
Kepros Physical Therapy and Performance
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52404
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Physical Therapy
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Big Stone Therapies (BST)
City
Big Stone City
State/Province
South Dakota
ZIP/Postal Code
57216
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Physical Therapy Sport Medicine
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54913
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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