Adhesive Capsulitis Clinical Trial
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
Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | January 31, 2030 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. . age between 20 to 80 years old; 2. . shoulder pain for = 1 months; 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Shin Kong Wu Ho-Su Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The pain visual analog scale (VAS) | The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain.22 The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated. | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. | |
Secondary | Range of motion(ROM) | All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction. | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. | |
Secondary | Shoulder Disability Questionnaire(SDQ) | The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition). | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. | |
Secondary | The 36-item Short Form Health Survey(SF-36) | The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health. | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. | |
Secondary | Self-assessment of the treatment effect | Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=5, effective=4, same=3, worse=2, much worse=1). | Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment. |
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