Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.
Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP+HA | Experimental | 5mL of PRP+HA |
|
| PRP injection | No Intervention | 4mL of PRP added 1 mL of lidocaine | |
| Steroid | No Intervention | 1 mL of rinderon added 4 mL of lidocaine | |
| PROLOTHERAPHY | Experimental | 4 mL of 20% dextrose added1 mL lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid, HA | Dietary Supplement | improve tissue repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley Shoulder Score (CMSS) | The Constant-Murley Shoulder Score (CMSS) is a multi-item functional scale assessing pain, ADL, ROM, and strength of the affected shoulder. score: 0-100. The higher score means the function feels good and painless. | before treatment, 4-week, 12-week, 24-week. |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was created by the Society of the American Shoulder and Elbow Surgeons in 1994 as a tool that applies to all shoulder diagnoses. score: 0-100. The higher score means the function feels good and painless. | before treatment, 4-week, 12-week, 24-week. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | Sanmin | 807 | Taiwan |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2023 | Jan 16, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006601 | Hexoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| range of motion of shoulder | ROM: flex, extension, abduction, adduction, internal rotation, external rotation. degree: 0-180. The higher degree means the shoulder rotation extends good and is painless. | before treatment, 4-week, 12-week, 24-week. |
| pain score (VAS) | score 0-10. The lower score means the function feels good and painless. | before treatment, 4-week, 12-week, 24-week. |
| the change of anatomy | Echo or MRI_Measure the wound size of rotator muscle rupture and confirm whether the wound has healed | before treatment, 4-week, 12-week, 24-week. |
| associated complications | infection, surgery, hypertrophic scar, consistent pain, etc. After the trial, the investigators calculate the rate of these complications. | before treatment, 4-week, 12-week, 24-week. |
| D009005 |
| Monosaccharides |
| D000073893 | Sugars |