Clinical trial NCT05983081: Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
Official title: Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: frozen shoulder
hyaluronic acid
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks.

group B: physical therapy
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
Secondary outcomes:
measure: Range of Motion
timeFrame: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Alberta
Study officials:
References: