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Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Injection Treatment
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring frozen shoulder, hyaluronic acid

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Injection Treatment

Physical Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 1, 2023
Last Updated
August 1, 2023
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05983081
Brief Title
Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
Official Title
Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
frozen shoulder, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks. group B: physical therapy
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injection Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Physical Therapy
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Injection Treatment
Intervention Description
Physical Therapy
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index
Description
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
Time Frame
before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
Secondary Outcome Measure Information:
Title
Range of Motion
Description
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.
Time Frame
before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
State/Province
Alberta
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIH-YA CHANG, MD
Phone
0287923311
Ext
13707
Email
gradesboy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

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