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

NCT ID: NCT05230667

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PRP injection (PRP group) and physical therapy

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.

Group Type: ACTIVE_COMPARATOR

Corticosteroid injection (CS group)

Intervention Type: OTHER

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.

Normal saline injection (NS group)

Intervention Type: OTHER

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.

Corticosteroid injection (CS group) and physical therapy

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.

Group Type: ACTIVE_COMPARATOR

PRP injection (PRP group)

Intervention Type: OTHER

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.

Normal saline injection (NS group)

Intervention Type: OTHER

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.

Normal saline injection (NS group) and physical therapy

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.

Group Type: ACTIVE_COMPARATOR

PRP injection (PRP group)

Intervention Type: OTHER

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.

Corticosteroid injection (CS group)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin-Fen Hsieh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin-Fen Hsieh

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

NSTC 111-2314-B-341-002 -

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024SKHADR037

Identifier Type: OTHER

Identifier Source: secondary_id

20211209R

Identifier Type: -

Identifier Source: org_study_id