Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

NCT06935877 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025SKHADR040
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subdeltoid Bursitis of the Shoulder

Outcome Measures

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

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

Secondary Outcomes (4)

• 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

• 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

• 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

• visual analog scale

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

Study Arms (2)

Intervention group

EXPERIMENTAL

traditional rehabilitation programs

Drug: Hyaluronic acid injection; Drug: Triamcinolone Acetonide injection

Control

ACTIVE COMPARATOR

Hyaluronic acid injection

Drug: Hyaluronic acid injection

Interventions

Hyaluronic acid injection DRUG

traditional rehabilitation programs

Also known as: Hyaluronic acid

Control; Intervention group

Triamcinolone Acetonide injection DRUG

traditional rehabilitation programs

Also known as: Triamcinolone Acetonide

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

MeSH Terms

Interventions

Hyaluronic Acid; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ru-Lan Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Ru-Lan Hsieh, Dr, MD

CONTACT

886 + 2-28332211; M001052@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share