1. The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain
- Author
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Kristine M. Hansen, Chong H. Kim, Douglas D. Gunzler, Travis Cleland, Victoria C. Whitehair, Terri Z. Hisel, Nitin B. Jain, Richard D. Wilson, and John Chae
- Subjects
Shoulder ,Population ,Placebo-controlled study ,Medicine (miscellaneous) ,law.invention ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,030202 anesthesiology ,law ,Shoulder Pain ,Deltoid muscle ,medicine ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,education ,Stroke ,Physical Therapy Modalities ,Pain Measurement ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,education.field_of_study ,business.industry ,Chronic pain ,medicine.disease ,United States ,3. Good health ,Exercise Therapy ,Treatment Outcome ,Shoulder Impingement Syndrome ,Anesthesia ,Chronic Disease ,Transcutaneous Electric Nerve Stimulation ,Axillary nerve ,lcsh:Medicine (General) ,business ,human activities ,030217 neurology & neurosurgery - Abstract
Background Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refractory to conservative treatment. For patients who fail conservative treatment, there is no established treatment to successfully treat their chronic pain. Prior randomized control trials have demonstrated efficacy for the use of a single lead intramuscular peripheral nerve stimulation of the axillary nerve at the motor points of the deltoid muscle for treatment of hemiplegic shoulder pain. This is the first controlled trial to utilize the same novel technology to treat shoulder impingement syndrome outside of the stroke population. Methods This is a dual-site, placebo-controlled, double-blinded, randomized control trial. Participants will be randomized to two treatment groups. The intervention group will be treated with active peripheral nerve stimulation of the axillary nerve of the affected shoulder and the control group will be treated with sham peripheral nerve stimulation of the axillary nerve of the affected shoulder. Both groups will receive a standardized exercise therapy program directed by a licensed therapist. Discussion This study protocol will allow the investigators to determine if this novel, non-pharmacologic treatment of shoulder pain can demonstrate the same benefit in musculoskeletal patients which has been previously demonstrated in the stroke population. Trial registration Clinicaltrials.gov, NCT03752619. Registered on 26 November 2018.
- Published
- 2020