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Completed

NCT Number: NCT05983081

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for the treatment of adhesive capsulitis (AC) of the shoulder.

Design: Prospective, randomized, parallel-group interventional trial Setting: Rehabilitation department of a medical center hospital. Participants: Participants: Patients with frozen-phase primary adhesive capsulitis Interventions: The patients received intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive weeks.

Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder; Shoulder pain and disability were measured using 2 questionnaires: the SPADI.

The patients were evaluated before treatment and were reevaluated 4, 6, 8, and 26 weeks after the beginning of the treatment.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Alberta, 114, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with frozen shoulder by a clinical physician based on the patient's medical history, physical examination, X-ray, and ultrasound or magnetic resonance imaging reports.
  • Clinical course: Patients must have a pain score of less than 3, no nighttime shoulder pain, and be in the post-freezing stage, primarily presenting restricted shoulder joint range of motion.
  • The affected shoulder joint must have at least two angles of shoulder joint movement reduced by at least 30% compared to the healthy side: shoulder flexion, abduction, and external rotation, or a single affected side abduction angle reduced by 50% relative to the healthy side.
  • Age between 40 to 70 years old.

Exclusion criteria

  • full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis.
  • Presence of systemic rheumatic disease.
  • History of shoulder fracture or previous shoulder surgery.
  • Received shoulder injections for treatment within the last 3 months.
  • Acute cervical nerve root compression.
  • Current pregnancy or lactation.
  • Patients with shoulder instability or cancer.
  • Patients with cognitive impairment, unable to follow simple instructions, or unable to comply with the study procedures.

Treatment and study plan

Hyaluronic acid

Drug

patients receives intra-articular injections of Hyaluronic acid. the injections were administered once a week for three consecutive weeks, total three injections per patients

Physical Therapy

Other

a week physical therapy program, consist of two sessions per week, (30 minutes each), including joint exercises, stretch and etc..

Primary outcomes

  1. Shoulder Pain and Disability Index

    Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation

    The SPADI consists of two subscales, pain, and disability, comprising a total of 13 items. Each item is rated on a scale from 0 (no pain/disability) to 10 (most severe pain/disability). Higher scores indicate greater functional impairment. The total score on the SPADI is used to determine the percentage of functional disability

Secondary outcomes

  1. Range of Motion

    Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation

    The ROM is assessed using a standardized goniometer in the standard position to measure the angles of shoulder joint movement on the affected side. It includes flexion, extension, abduction, external rotation, and internal rotation.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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