Shoulder Pain Chronic Clinical Trial
Official title:
Feasibility Study of the Bioness Battery-Powered Microstimulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects
The goal of this research study is to investigate the safety and effectiveness of a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.
This is a prospective, dual-center, randomized, controlled, double-blinded parallel study designed to evaluate the feasibility and safety of using the The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week study with a two-year follow up. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04093700 -
MDR SureLock All-Suture Anchor
|
||
Completed |
NCT03588143 -
Immediate Effects of TENS and HVPS on Subacromial Pain and Shoulder Movements
|
N/A | |
Completed |
NCT04190836 -
Self-Management for Persistent Subacromial Pain
|
Phase 1 | |
Completed |
NCT03547570 -
Resistance Training for Patients With Hypermobility Spectrum Disorders and Shoulder Symptoms: a Feasibility Study
|
N/A | |
Recruiting |
NCT05064033 -
Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies
|
N/A | |
Completed |
NCT02793401 -
Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound
|
Phase 4 | |
Recruiting |
NCT05001581 -
Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation
|
N/A | |
Completed |
NCT03088085 -
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
|
N/A | |
Recruiting |
NCT04124445 -
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain
|
N/A | |
Withdrawn |
NCT03797287 -
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
|
N/A | |
Completed |
NCT03869307 -
Shoulder Exercises in Hypermobile Patients With Shoulder Symptoms
|
N/A |