Subdeltoid Bursitis of the Shoulder
Conditions
Keywords
subdeltoid bursitis, hyaluronic acid, pain, function, quality of life
Brief summary
The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.
Detailed description
Evaluation indicators include pain (measured by Visual Analog Scale, 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).
Interventions
DEVICEHyaluronic Acid (HA), 2 ml, single injection
hyaluronic acid, 2ml, single injection
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Unilateral shoulder pain within the past 2 weeks 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
Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain and Disability Index | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability of the Arm, Shoulder, and Hand | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome | 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 |
| 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 | Range of motion of the shoulder joint, from 0 to 160, the higher range of motion, the greater function |
| World Health Organization Quality of Life | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome | Assesses 4 key domains: Physical Health, Psychological , Social Relationships and Environment, score ranges 0-100, higher score indicates greater health |
| visual analog scale | Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome | 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 |
Countries
Taiwan
Contacts
CONTACTRu-Lan Hsieh, Dr, MD
STUDY_CHAIRRu-Lan Hsieh
Shin Kong Wu Ho-Su Memorial Hospital
Outcome results
None listed