Effects of Hyaluronic Acid With Physical Therapy for Subdeltoid Bursitis

Therapeutic Effects of Hyaluronic Acid Combined With Physical Therapy in Treatment of Subdeltoid Bursitis

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the physical therapy combined 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Subdeltoid Bursitis of the Shoulder
• Intervention / Treatment: Device: Hyaluronic Acid (HA)

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-20
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cross-linked hyaluronic acid; cross-linked acid injection	Device: Hyaluronic Acid (HA); hyaluronic acid
Active Comparator: Non-crossed linked hyaluronic acid; non-cross-linked hyaluronic acid injection	Device: Hyaluronic Acid (HA); hyaluronic acid

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.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 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
Disability of the Arm, Shoulder, and Hand	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	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 motions of 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
• Investigators: Study Chair: Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

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; quality of life; function; hyaluronic acid; subdeltoid bursitis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: NSTC 114-2314-B-341-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not decided.

Drug and device information, study documents

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