Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

April 20, 2025 updated by: Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital

Comparison of the Efficacy of Combined Hyaluronic Acid and Triamcinolone Acetonide Injection and Hyaluronic Acid Alone Injection in Patients With Subdeltoid Bursitis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
traditional rehabilitation programs
Drug: Hyaluronic acid injection
traditional rehabilitation programs
Other Names:
  • Hyaluronic acid
Drug: Triamcinolone Acetonide injection
traditional rehabilitation programs
Other Names:
  • Triamcinolone Acetonide
Active Comparator: Control
Hyaluronic acid injection
Drug: Hyaluronic acid injection
traditional rehabilitation programs
Other Names:
  • Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index
Time Frame: 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
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder, and Hand
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
visual analog scale
Time Frame: 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
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Study Director: Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025SKHADR040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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