Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

June 16, 2023 updated by: Taipei Veterans General Hospital, Taiwan

Steroid and Sodium Hyaluronate Hydrodilatation

This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 35-65 years
  2. onset of shoulder stiffness since over a month
  3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

  1. ultrasound findings of rotator cuff tears,
  2. plain radiography findings of significant glenohumeral joint arthritis,
  3. accompanying cervical radiculopathy,
  4. systemic inflammatory joint disease,
  5. intraarticular injection into the glenohumeral joint within the past 3 months
  6. history of surgery on the affected shoulders,
  7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
  8. allergy to corticosteroid or lidocaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydrodilatation with steroid
patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
Drug: lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Drug: normal saline
Ultrasound guided injection using 3ml normal saline
Drug: Triamcinolone Acetonide
ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide
Active Comparator: hydrodilatation with hyaluronic acid and steroid
patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
Drug: lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Drug: Triamcinolone Acetonide
ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide
Drug: (Sodium Hyaluronate (Hyruan One , LG)
Ultrasound guided injection using 3ml of Sodium Hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain intensity
Time Frame: 0, 6, 12weeks
pain intensity was measured by visual analog scale (0-10)
0, 6, 12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Shoulder Pain And disability index
Time Frame: 0, 6, 12 weeks
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
0, 6, 12 weeks
change in glenohumeral joint range of motion
Time Frame: 0, 6, 12weeks
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
0, 6, 12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2023

Primary Completion (Estimated)

April 6, 2024

Study Completion (Estimated)

April 6, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01-001B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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