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The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded
Andrew A Post1, Dana L Dailey1,2, Emine O Bayman3,4,5
1Department of Physical Therapy and Rehabilitation Science, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.
Physical Therapy
|August 29, 2022
Summary
This study investigates if adding Transcutaneous Electrical Nerve Stimulation (TENS) to physical therapy reduces movement pain for fibromyalgia patients. Findings will guide non-drug pain management strategies.
Area of Science:
- Pain Management
- Neurology
- Rehabilitation Medicine
Background:
- Fibromyalgia is a chronic condition characterized by widespread pain and fatigue.
- Nonpharmacological interventions are crucial for managing fibromyalgia symptoms.
- Transcutaneous Electrical Nerve Stimulation (TENS) offers a potential non-drug approach to analgesia.
Purpose of the Study:
- To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to physical therapy for improving movement-evoked pain in fibromyalgia patients.
- To assess the impact of TENS on various secondary outcomes including resting pain, fatigue, and overall fibromyalgia disease activity.
Main Methods:
- A phase III embedded pragmatic clinical trial with a randomized cluster design involving 24-30 physical therapy clinics.
- 600 participants will be enrolled, with clinics randomized to either TENS or No-TENS groups.
- The primary outcome is the reduction in movement-evoked pain measured by the Sit and Stand Test over 60 days.
Main Results:
- Data collection is ongoing; primary and secondary outcome results are pending.
- The study is designed to provide robust effectiveness data on TENS in a real-world clinical setting.
Conclusions:
- The study aims to provide crucial effectiveness data on TENS for fibromyalgia patients to inform healthcare policy and clinical practice.
- Findings will guide future pragmatic trials for nonpharmacological pain interventions and chronic musculoskeletal conditions.
