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

Shin Kong Wu Ho-Su Memorial Hospital

Status: Completed

Conditions: Corticosteroid; Platelet-rich Plasma; Injection; Shoulder; Frozen Shoulder; Adhesive Capsulitis

Treatments: Other: Corticosteroid injection (CS group); Other: Normal saline injection (NS group); Other: PRP injection (PRP group)

Study type: Interventional

Funder types: Other

Identifiers

NCT05230667

NSTC 111-2314-B-341-002 - (Other Grant/Funding Number)

2024SKHADR037 (Other Identifier)

20211209R

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age between 20 to 80 years old;
2. shoulder pain for ≥ 1 month;
3. > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
4. visual analog scale for pain on maximal passive external rotation or abduction > 4;
5. an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain;
6. showing willing to attend regular physical therapy programs for 8 weeks.

Exclusion criteria

1. severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
2. uncontrolled DM;
3. rotator cuff tear or calcification of the affected shoulder;
4. fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
5. a hard end feel on passive external rotation or abduction of the affected shoulder;
6. a history of drug allergy to local anesthetics or corticosteroids;
7. receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 3 patient groups

PRP injection (PRP group) and physical therapy

Active Comparator group

Description:

Patients in the PRP group will receive both shoulder joint (GHJ) and SASD bursa injection for 2 times in 2-week interval. 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. Physical therapy will be conducted for 8 weeks.

Treatment:

Other: Normal saline injection (NS group)

Other: Corticosteroid injection (CS group)

Corticosteroid injection (CS group) and physical therapy

Active Comparator group

Description:

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) for 2 times in 2-week interval. The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.

Treatment:

Other: PRP injection (PRP group)

Other: Normal saline injection (NS group)

Normal saline injection (NS group) and physical therapy

Active Comparator group

Description:

Four 4ml 1% xylocaine mixed with 5ml normal saline will be injected into the affected GHJ (6ml) and SASD bursa (3ml) for 2 times in 2-week interval . The techniques of injection are the same as those used in the PRP injection. Physical therapy will be conducted for 8 weeks.

Treatment:

Other: PRP injection (PRP group)

Other: Corticosteroid injection (CS group)