Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Tri-Service General Hospital

Status: Enrolling

Conditions: Adhesive Capsulitis

Treatments: Procedure: Injection Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05983081

TSGH

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Injection Treatment

Experimental group

Description:

A- Experimental Group: Intra-articular Hyaluronic Acid Injection Treatment Regimen Patients in the experimental group received ultrasound-guided intra-articular injections of hyaluronic acid (Artibest, 60 mg/3 ml, 2%, manufactured by Kang Stem Biotech, Taiwan) into the affected shoulder joint. The injections were administered once a week for three consecutive weeks, totaling three injections per patient. The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.

Treatment:

Procedure: Injection Treatment

Physical Therapy

No Intervention group

Description:

B- Control Group: Physical Therapy Patients in the control group underwent a 6-week physical therapy program, consisting of two sessions per week, with each session lasting approximately 30 minutes. The physical therapy program was conducted under the guidance and supervision of a physical therapist and included joint exercises, stretching, and muscle strengthening exercises.