Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

Shin Kong Wu Ho-Su Memorial Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Subdeltoid Bursitis of the Shoulder

Treatments: Drug: Triamcinolone Acetonide injection; Drug: Hyaluronic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06935877

2025SKHADR040

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

traditional rehabilitation programs

Treatment:

Drug: Hyaluronic acid injection

Drug: Triamcinolone Acetonide injection

Control

Active Comparator group

Description:

Hyaluronic acid injection

Treatment:

Drug: Hyaluronic acid injection