Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983081
• Other study ID #: TSGH
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Design: Prospective, case- controlled trial. Setting: Rehabilitation department of a medical center hospital. Participants: Patients (30) with AC 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, 12 weeks after the beginning of the treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

A. 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.

B. 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.

C. 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.

D. Age between 40 to 70 years old.

-

Exclusion Criteria:

A. full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis.

B. Presence of systemic rheumatic disease. C. History of shoulder fracture or previous shoulder surgery. D. Received shoulder injections for treatment within the last 3 months. E. Acute cervical nerve root compression. F. Current pregnancy or lactation. G. Patients with shoulder instability or cancer. H. Patients with cognitive impairment, unable to follow simple instructions, or unable to comply with the study procedures.

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Procedure:
• Injection Treatment
Physical Therapy

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index	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	before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
Secondary	Range of Motion	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.	before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.