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

NCT05230667 | Completed DMC

• 3 other identifiers: 20211209RNSTC 111-2314-B-341-002 -2024SKHADR037
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Frozen shoulder; adhesive capsulitis; shoulder; platelet-rich plasma; corticosteroid; injection

Outcome Measures

Primary Outcomes (1)

• The Shoulder Pain and Disability Index (SPADI)

  The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

Secondary Outcomes (5)

• The pain visual analog scale (VAS)

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

• Range of motion（ROM）

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

• Shoulder Disability Questionnaire（SDQ）

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

• The 36-item Short Form Health Survey（SF-36）

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

• Self-assessment of the treatment effect

  Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.

Study Arms (3)

PRP injection (PRP group) and physical therapy

ACTIVE COMPARATOR

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.

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

Corticosteroid injection (CS group) and physical therapy

ACTIVE COMPARATOR

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.

Other: PRP injection (PRP group); Other: Normal saline injection (NS group)

Normal saline injection (NS group) and physical therapy

ACTIVE COMPARATOR

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.

Other: PRP injection (PRP group); Other: Corticosteroid injection (CS group)

Interventions

PRP injection (PRP group) 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) and physical therapy; Normal saline injection (NS group) and physical therapy

Corticosteroid injection (CS group) 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) and physical therapy; PRP injection (PRP group) and physical therapy

Normal saline injection (NS group) 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; PRP injection (PRP group) and physical therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

TW (1)