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Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05983081
Enrollment
46
Registered
2023-08-09
Start date
2023-08-01
Completion date
2024-08-14
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

frozen shoulder, hyaluronic acid

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.

Interventions

DRUGhyaluronic acid

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

OTHERPhysical Therapy

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

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability Indexbaseline, 4, 6, 8, and 26 weeks after treatment initiationThe 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

MeasureTime frameDescription
Range of Motionbaseline, 4, 6, 8, and 26 weeks after treatment initiationThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026