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Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder

NCT07570095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-15

No results posted yet for this study

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.

The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight.

The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.

Conditions

  • Adhesive Capsulitis
  • Frozen Shoulder

Interventions

DRUG

Hyaluronic Acid (HA)

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.

OTHER

Rehabilitation

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

Sponsors & Collaborators

  • Tri-Service General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2025-03-05
Completion
2026-04-28

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570095 on ClinicalTrials.gov