Additional Effect of Steroid on Hyaluronic Acid in 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Unilateral shoulder pain within the past 3 months

Disqualifiers

Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic acid injection

    Drug

    traditional rehabilitation programs

  • Triamcinolone Acetonide injection

    Drug

    traditional rehabilitation programs

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: ControlActive 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 outcome

Secondary outcomes

1

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

Time frame
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
2

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

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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