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The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.
Evaluation indicators include pain (measured by Visual Analog Scale for rest, activity, and sleep, and pain threshold via pressure algometer), function (assessed by Disabilities of the Arm, Shoulder, and Hand score and Shoulder Pain and Disability Index), quality of life (using the World Health Organization Quality of Life-BREF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | traditional rehabilitation programs |
|
| Control | Active Comparator | Hyaluronic acid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid injection | Drug | traditional rehabilitation programs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index | A questionnaire to evaluate the severity of shoulder pain and disability in patients with shoulder problems; higher scores indicated more significant pain and disability.The score ranges from 0 to 100: 0 = no disability; 100 = most severe disability | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand | The questionnaire to measure physical function and symptoms in people with upper-limb disorders, including conditions affecting the shoulder, elbow, wrist, or hand. The score ranges from 0 to 100: 0 = no disability; 100 = most severe disability | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome |
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Inclusion Criteria:
Pain during joint movements such as abduction or internal rotation
At least one positive result from the following tests: Painful arc, Neer test, or Hawkins test
No shoulder injections received in the past 3 months
Willingness to receive injection treatment and undergo follow-up assessments at the following time points:
Immediate (1 week after injection)
Short-term (1 month after injection)
Mid-term (3 months after injection)
Avoid use of anti-inflammatory painkillers during the study period as much as possible; if intolerable pain occurs, acetaminophen (provided by the researcher) will be used to relieve symptoms
Exclusion Criteria:
History of malignancy
Previous shoulder surgery
Sensory deficits
Tendon rupture of the rotator cuff or biceps tendon
Neurological disorders causing hand weakness or affecting shoulder mobility (e.g., stroke, Parkinson's disease, brachial plexus injury, peripheral neuropathy)
Cognitive impairment preventing completion of questionnaires
Cervical radiculopathy
Diagnosed frozen shoulder (adhesive capsulitis)
Psychiatric disorders
Breastfeeding or pregnant women
Received shoulder injection within the past 3 months, including corticosteroids, hyaluronic acid, Platelet-rich plasma, or any prolotherapy solution
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh, Dr, MD | Contact | 886 + 2-28332211 | M001052@ms.skh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh | Shin Kong Wu Ho-Su Memorial Hospital | Study Director |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D014221 | Triamcinolone |
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| Triamcinolone Acetonide injection | Drug | traditional rehabilitation programs |
|
|
| Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome | Range of motions of shoulder joint | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome |
| World Health Organization Quality of Life | Assesses 4 key domains: Physical Health, Psychological , Social Relationships and Environment, score ranges 0-100, higher score indicates greater health | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome |
| visual analog scale | Measuring subjective pain intensity, score ranges from 0 to 10 (or 0 to 100 mm, depending on format), the higher score indicates more severe symptom | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |