Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
Fibromyalgia
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
Inclusion Criteria:
- Age 18 until 99.
- Clinician diagnosis of FM
- 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)
- 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
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
Active Comparator
Other
TENS with PT
No 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.
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.