Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

NCT ID: NCT06935877

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2026-06-30

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).

Conditions

Subdeltoid Bursitis of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

traditional rehabilitation programs

Group Type: EXPERIMENTAL

Hyaluronic acid injection

Intervention Type: DRUG

traditional rehabilitation programs

Triamcinolone Acetonide injection

Intervention Type: DRUG

traditional rehabilitation programs

Control

Hyaluronic acid injection

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid injection

Intervention Type: DRUG

traditional rehabilitation programs

Interventions

Hyaluronic acid injection

traditional rehabilitation programs

Intervention Type: DRUG

Triamcinolone Acetonide injection

traditional rehabilitation programs

Intervention Type: DRUG

Other Intervention Names

Hyaluronic acid; Triamcinolone Acetonide

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ru-Lan Hsieh

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ru-Lan Hsieh

Role: STUDY_DIRECTOR

Shin Kong Wu Ho-Su Memorial Hospital

Central Contacts

Ru-Lan Hsieh, Dr, MD

Role: CONTACT

M001052@ms.skh.org.tw

886 + 2-28332211

Other Identifiers

2025SKHADR040

Identifier Type: -

Identifier Source: org_study_id