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Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.
A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, 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) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Dextrose injection, one time |
|
| Control group | Placebo Comparator | Normal saline injection, one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose | Drug | Dextrose injection plus 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 | 886-2-28332211 | 2531 | 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 |
|---|---|
| D005947 | Glucose |
| D026741 | Physical Therapy Modalities |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D013812 |
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| Normal saline | Drug | Normal saline injection plus 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 |
| Therapeutics |
| D012046 | Rehabilitation |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |