Effect of Different Hyaluronic Acids in the Treatment of Subdeltoid Bursitis

Effect of Different Molecular-Weight Hyaluronic Acid in the Treatment of Subdeltoid Bursitis: A Double-Blind Randomized Controlled Trial

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subdeltoid Bursitis of the Shoulder
• Intervention / Treatment: Drug: ultra-high molecular weigth hyaluronic acid injection; Drug: high molecular hyaluronic acid injection

Detailed Description

Evaluation indicators include pain (measured by Visual Analog Scale), 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): 52
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ru-Lan Hsieh, MD; Phone Number: Telephone: 886 + 2-28332211 Ex; Email: rulanhsieh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultra-high molecular weight hyaluronic acid	Drug: ultra-high molecular weigth hyaluronic acid injection; ultra-high molecular weight hyaluronic acid
Active Comparator: high molecular weight hyaluronic acid	Drug: high molecular hyaluronic acid injection; Ultrasound-guided injection into subdeltoid bursa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
World Health Organization Quality of Life	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	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
Disabilities of the Arm, Shoulder, and Hand	The questionnaire measures 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
Range of motions of shoulder joint	Range of motion of the shoulder joint	Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pain; hyaluronic acid; subdeltoid bursitis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 2026SKHADR035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be available upon request to the investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No