Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

Phase 4

Not yet recruiting

• Conditions: Subdeltoid Bursitis of the Shoulder
• Interventions: Drug: Hyaluronic acid injection; Drug: Triamcinolone Acetonide injection

• Registration Number: NCT06935877
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary

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.

Detailed Description

Evaluation indicators include pain (measured by Visual Analog Scale for rest, activity, and sleep, 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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-13
• Study First Posted: 2025-04-20
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24
• Study Start: 2025-04-25
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• • Unilateral shoulder pain within the past 3 months

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Hyaluronic acid injection	traditional rehabilitation programs
Intervention group	Triamcinolone Acetonide injection	traditional rehabilitation programs
Control	Hyaluronic acid injection	Hyaluronic acid injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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