Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation?

January 2, 2024 updated by: Sibel süzen Özbayrak, Haydarpasa Numune Training and Research Hospital
The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study.

Inclusion Criteria

Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study.

Exlusion Criteria

  1. A history of physical therapy or injections for the shoulder joint within the previous three months,
  2. The existence of a neurological condition or surgical history that could impair upper limb functions,
  3. Being a breastfeeding or pregnant woman,
  4. Mental illnesses and cognitive impairments that impair cooperation
  5. Diabetes mellitus with unregulated glucose levels
  6. Presenece of Cancer

Patients included in the study will be divided into two groups by block randomization.

In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.

The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.

All the patients will be evaluated by a doctor who is blind to the study groups. Demographic information, history of shoulder pain, presence of chronic diseases, pain severity measured by VAS during resting,activity and sleep will be recorded. Physical examination including shoulder range of motion, will be evaluated. Shoulder Disability Index will be used for evaluating the functional status of shoulder. They will be evaluated before and immediately after injection, 1 week later, 1 month and 2 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.

Study Type

Interventional

Enrollment (Estimated)

70

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

  • Turkey
    • Uskudar
      • Istanbul, Uskudar, Turkey, 34668
        • Recruiting
        • Health Science University Haydarpasa Numune Research and Training 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:

Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.

Exclusion Criteria:

  1. A history of physical therapy or injections for the shoulder joint within the previous three months,
  2. The existence of a neurological condition or surgical history that could impair upper limb functions,
  3. Being a breastfeeding or pregnant woman,
  4. Mental illnesses and cognitive impairments that impair cooperation
  5. Diabetes mellitus with unregulated glucose levels
  6. Presence of Cancer

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.
Drug: Triamcinolone Acetonide
  1. group will receive ultrasound-guided hydrodilatation
  2. group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder
Other Names:
  • lidocaine
  • serum physiologic
Active Comparator: Group 2
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. The amount of fluid given will be recorded. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.
Drug: Triamcinolone Acetonide
  1. group will receive ultrasound-guided hydrodilatation
  2. group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder
Other Names:
  • lidocaine
  • serum physiologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analouge Scale (VAS)
Time Frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Pain Severity
Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Range of Motion
Time Frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Limitation
Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Disability Index
Time Frame: Before injection, 1 week,1 month and 2 moths after injection
Shouler Disability
Before injection, 1 week,1 month and 2 moths after injection

Collaborators and Investigators

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

Sponsor

Haydarpasa Numune Training and Research Hospital

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)

December 18, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNEAH-KAEK/KK/2023/210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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