Effects of Hyaluronic Acid for Subdeltoid Bursitis

NCT07729527 | Not Yet Recruiting

• 1 other identifier: NSTC 114-2314-B-341-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subdeltoid Bursitis of the Shoulder

Keywords

subdeltoid bursitis; hyaluronic acid; pain; function; quality of life

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)

• Disability 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

• 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

  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)

cross-linked hyaluronic acid

EXPERIMENTAL

cross-linked acid injection

Device: Hyaluronic Acid (HA), 2 ml, single injection

Non-crossed linked hyaluronic acid

ACTIVE COMPARATOR

non-cross-linked hyaluronic acid injection

Device: Hyaluronic Acid (HA), 2 ml, single injection

Interventions

Hyaluronic Acid (HA), 2 ml, single injection DEVICE

hyaluronic acid, 2ml, single injection

Non-crossed linked hyaluronic acid; cross-linked hyaluronic acid

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 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

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

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-20, Taiwan

Location

MeSH Terms

Conditions

Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ru-Lan Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Ru-Lan Hsieh, Dr, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Medicine and Rehabilitationj

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)