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NCT Number: NCT06935877

Additional Effect of Steroid on Hyaluronic Acid in 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.

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Key information

Conditions

Subdeltoid Bursitis of the Shoulder

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid injection

Drug

traditional rehabilitation programs

Other names: Hyaluronic acid

Triamcinolone acetonide injection

Drug

traditional rehabilitation programs

Other names: Triamcinolone Acetonide

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ru-Lan Hsieh, Dr, MD

CONTACT

[email protected]

886 + 2-28332211

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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