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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
hyaluronic acid, 2ml, single injection
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
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
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Disability 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
Time frame: 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
Range of motion of the shoulder joint, from 0 to 160, the higher range of motion, the greater function
Time frame: 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
Time frame: 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
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
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