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This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.
A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cross-linked hyaluronic acid group | Experimental | cross-linked hyaluronic acid injection, one-time, plus physical therapy |
|
| non-cross-linked hyaluronic acid group | Active Comparator | non-cross-linked hyaluronic acid injection, one-time, plus physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cross-linked hyaluronic acid | Drug | cross-linked hyaluronic acid injection with physical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain and disability index | measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability | score change from baseline to 1 week, 1 month and 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the arm, shoulder, and hand | measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability | score change from baseline to 1 week, 1 month and 3 months after treatment |
| Visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh, MD | Contact | 882-2-28332211 | 2538 | M001052@ms.skh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh, MD | Shin Kong Wu Ho-Su Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| non-cross-linked hyaluronic acid | Drug | non-cross-linked hyaluronic acid injection with physical therapy |
|
|
measure shoulder pain, ranges from 0-10, higher score indicate more pain |
| score change from baseline to 1 week, 1 month and 3 months after treatment |
| range of motion | measure shoulder range of motion, higher score indicate higher range of motion | score change from baseline to 1 week, 1 month and 3 months after treatment |
| Brief version of the World Health Organization Quality of Life Scale | measure quality of life, ranges from 0-100, higher scores indicate better quality of life | score change from baseline to 1 week, 1 month and 3 months after treatment |