Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Adhesive Capsulitis
Shoulder
Platelet-rich Plasma
Corticosteroid
Injection
Keywords: Frozen shoulder
adhesive capsulitis
shoulder
platelet-rich plasma
corticosteroid
injection
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary outcomes:
measure: The pain visual analog scale (VAS)
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Range of motion（ROM）
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Shoulder Disability Questionnaire（SDQ）
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
measure: The 36-item Short Form Health Survey（SF-36）
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Self-assessment of the treatment effect
timeFrame: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh
role: PRINCIPAL_INVESTIGATOR
References: