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Not yet recruiting NCT06935877

Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

Phase IV Interventional Subdeltoid Bursitis of the Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic acid injection, Triamcinolone Acetonide injection.
Who it may be relevant to
Registry conditions: Subdeltoid Bursitis of the Shoulder. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Drug Hyaluronic acid injection
    traditional rehabilitation programs
  • Drug Triamcinolone Acetonide injection
    traditional rehabilitation programs

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • visual analog scale [Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06935877 · 2025SKHADR040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗