Effects of Hyaluronic Acid for Subdeltoid Bursitis
ConditionSubdeltoid Bursitis of the Shoulder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorShin Kong Wu Ho-Su Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic Acid (HA), 2 ml, single injection
Devicehyaluronic acid, 2ml, single injection
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: cross-linked hyaluronic acidExperimental treatment 1 intervention
Group B: Non-crossed linked hyaluronic acidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 outcomeSecondary outcomes
1
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 outcome2
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 outcome3
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 outcome4
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 outcomeSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: