Clinical trial NCT06935877: Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis
Official title: Comparison of the Efficacy of Combined Hyaluronic Acid and Triamcinolone Acetonide Injection and Hyaluronic Acid Alone Injection in Patients With Subdeltoid Bursitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Subdeltoid Bursitis of the Shoulder
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
measure: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
timeFrame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
measure: World Health Organization Quality of Life
timeFrame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
measure: visual analog scale
timeFrame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Other outcomes:
Locations:
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh
role: STUDY_DIRECTOR
References: