Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder

NCT07570095 | Completed DMC

• 1 other identifier: C202205160
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the clinical efficacy of ultrasound-guided intra-articular hyaluronic acid injection combined with rehabilitation in patients with adhesive capsulitis (frozen shoulder). Participants were randomly assigned to either an injection plus rehabilitation group or a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid once weekly for three weeks, along with a standardized rehabilitation program for six weeks. The control group received the same rehabilitation program without injection. Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome was the change in the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder range of motion. This study was registered retrospectively after study initiation due to administrative oversight.

Conditions

Adhesive Capsulitis; Frozen Shoulder

Keywords

Hyaluronic Acid; Ultrasound-Guided Injection; Rehabilitation; SPADI

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI) Total Score

  The SPADI is a validated questionnaire assessing shoulder pain and functional disability, with total scores ranging from 0 to 100. Higher scores indicate greater impairment.

  Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks

Study Arms (2)

Hyaluronic Acid Injection + Rehabilitation

EXPERIMENTAL

Participants receive ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid (10 mg/mL, once weekly for 3 consecutive weeks) combined with a standardized rehabilitation program consisting of joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks.

Drug: Hyaluronic Acid (HA); Other: Rehabilitation

Rehabilitation Alone

ACTIVE COMPARATOR

Participants receive a standardized rehabilitation program including joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks without hyaluronic acid injection.

Other: Rehabilitation

Interventions

Hyaluronic Acid (HA) DRUG

Non-cross-linked hyaluronic acid (10 mg/mL) administered via ultrasound-guided intra-articular injection into the affected shoulder joint once weekly for 3 weeks.

Hyaluronic Acid Injection + Rehabilitation

Rehabilitation OTHER

Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.

Hyaluronic Acid Injection + Rehabilitation; Rehabilitation Alone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 to 80 years.
• Clinical diagnosis of adhesive capsulitis (frozen shoulder) characterized by shoulder pain and restricted range of motion for at least 1 month.
• Limitation of both active and passive shoulder range of motion, particularly in external rotation.
• Ability to understand the study procedures and provide informed consent.

You may not qualify if:

• Prior shoulder surgery or fracture on the affected side.
• Rotator cuff tear confirmed by imaging.
• Glenohumeral osteoarthritis or inflammatory joint disease.
• Neurological disorders affecting shoulder function.
• Previous intra-articular injection within the past 3 months.
• Contraindications to hyaluronic acid injection.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Hyaluronic Acid; Rehabilitation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Randomized

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: February 5, 2025
• Primary Completion: March 5, 2025
• Study Completion: April 28, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)