Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

NCT05983081 | Completed DMC

• 1 other identifier: C202205161
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Adhesive Capsulitis

Keywords

frozen shoulder; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 4, 6, 8, and 26 weeks after treatment initiation

Secondary Outcomes (1)

• Range of Motion

  baseline, 4, 6, 8, and 26 weeks after treatment initiation

Study Arms (2)

Intra-articular Hyaluronic Acid Injection

EXPERIMENTAL

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 and 26 weeks after the treatment.

Drug: hyaluronic acid

Physical Therapy

ACTIVE COMPARATOR

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. 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 and 26 weeks after the treatment.

Other: Physical Therapy

Interventions

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

Intra-articular Hyaluronic Acid Injection

Physical Therapy OTHER

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

Physical Therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Alberta, 114, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Hyaluronic Acid; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks. group B: physical therapy

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)