Effects of Hyaluronic Acid for Subdeltoid Bursitis

Official title

Therapeutic Effects of Hyaluronic Acid in the Treatment of Subdeltoid Bursitis

Overview

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid 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, 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

• Device Hyaluronic Acid (HA), 2 ml, single injection
  hyaluronic acid, 2ml, single injection

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)

• Disability 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]
• Range of motions of shoulder joint [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 2 weeks 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

Quadruple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Identifiers

NCT: NCT07729527 · NSTC 114-2314-B-341-005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗