NCT05230667

Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.

Detailed description

This is a prospective assessor-blinded randomized controlled trial. We plan to enroll 90 participants with frozen shoulder from the outpatient clinic of the Department of Physical Medicine and Rehabilitation in our hospital. The study protocol and consent form have been approved by our ethics committee. After detailed explanation about the content of this study, participant is asked to sign an informed consent. The patients will be randomly divided into three groups: 1). PRP injection (PRP group); 2). Corticosteroid injection (CS group); 3). Normal saline injection (NS group). Randomization will be assigned according to a random number from a computer program by a statistician. The patients and the evaluator are unknown which group the patients are allocated, but the physician who performs joint injection knows which group the patients are assigned.

Conditions

• Frozen Shoulder
• Adhesive Capsulitis
• Shoulder
• Platelet-rich Plasma
• Corticosteroid
• Injection

Interventions

Type	Name	Description
OTHER	PRP injection (PRP group)	Patients in the PRP group will receive both shoulder joint (GHJ) and SASD bursa injection for one time. PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. About 2ml PRP and 3ml platelet poor plasma (PPP) will be extracted, then 4ml 1% xylocaine will be added to make 9ml injectate. 6ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. Another 3ml injectate will be injected into the SASD bursa of the affected shoulder with a 3.8 cm 22-gauge needle under US guidance.
OTHER	Corticosteroid injection (CS group)	Three ml triamcinolone (1ml= 10mg), 4ml 1% xylocain, and 2ml normal saline to make a 9ml injectate is injected into the affected shoulder (6ml to posterior GHJ and 3 ml to SASD bursa). The techniques of injection are the same as those used in the PRP injection.
OTHER	Normal saline injection (NS group)	Four 4ml 1% xylocaine mixed with 5ml normal saline will be injected into the affected GHJ (6ml) and SASD bursa (3ml). The techniques of injection are the same as those used in the PRP injection.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-02-09
• Last updated: 2025-06-24

Locations

1 site across 1 country: Taiwan