Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder (HA - AC)

May 12, 2026 updated by: Chih-Ya Chang, Tri-Service General Hospital

Clinical Outcomes of Ultrasound-Guided Intra-Articular Hyaluronic Acid Injection Combined With Rehabilitation in Adhesive Capsulitis: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adhesive capsulitis is a common musculoskeletal disorder characterized by progressive pain and restricted range of motion of the shoulder joint, leading to significant functional impairment. Although rehabilitation remains the cornerstone of treatment, the additional benefit of intra-articular hyaluronic acid injection remains controversial.

This randomized controlled trial aimed to evaluate the clinical efficacy of ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid combined with a structured rehabilitation program in patients with adhesive capsulitis.

Participants were randomly assigned to two groups: an injection plus rehabilitation group and a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid injections once weekly for three consecutive weeks. Both groups underwent a standardized rehabilitation program twice weekly for six weeks, including range of motion exercises, stretching, and strengthening under the supervision of a physical therapist.

Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome measure was the change in the Shoulder Pain and Disability Index (SPADI) total score over time. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder external rotation 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 40 to 70 years.
  • Clinical diagnosis of frozen-phase primary adhesive capsulitis characterized by predominant stiffness as the chief complaint, with symptom duration of at least 3 months, minimal resting pain, and absence of nocturnal pain.
  • Limitation of both active and passive shoulder range of motion, particularly in external rotation.
  • Ability to understand the study procedures and provide informed consent.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid Injection + Rehabilitation
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)
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.
Active Comparator: Rehabilitation Alone
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
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI) Total Score
Time Frame: Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPADI Item - Wearing a Pullover Shirt
Time Frame: Baseline, 4, 6, 8, and 12 weeks
Item-level SPADI score for wearing a pullover shirt (requires combined abduction and external rotation), rated 0-10 (0=no difficulty, 10=worst difficulty).
Baseline, 4, 6, 8, and 12 weeks
SPADI Item - Putting on Pants or Shorts
Time Frame: Time Frame: Baseline, 4, 6, 8, and 12 weeks
Item-level SPADI score for putting on pants or shorts (requires internal rotation and extension), rated 0-10.
Time Frame: Baseline, 4, 6, 8, and 12 weeks
SPADI Item - Pain on Arm Traction
Time Frame: Time Frame: Baseline, 4, 6, 8, and 12 weeks
Item-level SPADI pain score during arm traction of the affected side (reflects capsular tension), rated 0-10.
Time Frame: Baseline, 4, 6, 8, and 12 weeks
Shoulder Range of Motion
Time Frame: Baseline, 4, 6, 8, and 12 weeks
Active and passive range of motion of the shoulder (flexion, abduction, external rotation) measured by gravity goniometer by a blinded assessor.
Baseline, 4, 6, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

April 28, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C202205160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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