Effect of Different Hyaluronic Acids in the Treatment of Subdeltoid Bursitis

Trial statusNot yet recruiting
Trial phasePhase 4
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: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight 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 accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultra-high molecular weight hyaluronic acid injection

    Drug

    ultra-high molecular weight hyaluronic acid

  • high molecular weight hyaluronic acid injection

    Drug

    Ultrasound-guided injection into subdeltoid bursa

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: ultra-high molecular weight hyaluronic acidExperimental treatment 1 intervention
Group B: high molecular weight 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

Time frame
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

Secondary outcomes

1

Disabilities of the Arm, Shoulder, and Hand

The questionnaire measures 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
2

Range of motions of shoulder joint

Range of motion of the shoulder joint

Time frame
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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