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Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis.

Primary Purpose

Adhesive Capsulitis of the Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)
Sponsored by
Kartal City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of the Shoulder focused on measuring adhesive capsulitis, steroid injection, ultrasound-guided

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: must be between the ages of 18-75 clinically and radiologically confirmed adhesive capsulitis Exclusion Criteria: Patients with a tear in any of the rotator cuff tendons Patients who have had steroid injections in the shoulder region before patients who have been treated with the diagnosis of adhesive capsulitis (except for oral non-steroidal anti-inflammatory drug therapy) Patients with a previous history of trauma-fracture-dislocation in the shoulder region

Sites / Locations

  • Kartal Dr Lutfi Kirdar City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

posterior intra-articular steroid injection under USG guidance

anterior extra-articular steroid injection under USG guidance

Arm Description

Intra-articular steroid injection will be performed to the glenohumeral joint from the posterior, 2cm inferior and 2cm medial of the acromion posterolateral corner, under the guidance of USG.

Steroid injection will be performed from the anterior, immediately lateral to the coracoid process, to the CHL localization, to the extra-articular area under the guidance of USG.

Outcomes

Primary Outcome Measures

The Visual Analogue Scale(VAS)
The change of Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.We noted the changes within this scoring system between the time framed which is stated below
external rotation of shoulder
The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer.
abduction of shoulder
The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer.
flexion of shoulder
The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer.
Internal rotation of the shoulder
The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
April 19, 2023
Sponsor
Kartal City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05668286
Brief Title
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis.
Official Title
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Anticipated)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
December 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kartal City Hospital

4. Oversight

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

5. Study Description

Brief Summary
In the treatment of adhesive capsulitis, conservative treatment usually gives successful results, and steroid injection is an effective method that is frequently preferred among conservative treatment modalities. However, many controversial issues have not yet been clarified in the literature, such as the location of the injection, whether into the glenohumeral joint or around the coracohumeral ligament where the most radiological findings are detected.
Detailed Description
Purpose: To compare the intra-articular steroid administration with the extra-articular one; around the coracohumeral ligament in patients with adhesive capsulitis. Method: Ethics committee approval was obtained for the study. Patients who were diagnosed with adhesive capsulitis in the orthopedic outpatient clinic were included. Diagnosis was confimed by physical examination and Magnetic Resonance Imaging (MRI) findings. Patients with radiological finding of any tear in the rotator cuff or long head of biceps tendons were excluded. Only patients in the freezing or frozen stage of the disease were included. Patients who were previously treated with the diagnosis of adhesive caspulitis or who received any injections to the shoulder joint were not included in the study. Included patients were randomly divided into two groups according to age, sex, duration of complaint, concomitant diabetes mellitus (DM) disease and clinical stage of the disease. For randomization, stratified randomization was applied according to the information obtained from the outpatient clinic. While patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients. Patients were first evaluated before injection, than randomized to groups and prospectively followed up by an orthopaedic surgeon who was blinded to the groups. Evaluation was done for pain (visual analog scale score; VAS), functional status (American Shoulder and Elbow Surgeons score; ASES and Quick Disabilities of the Arm, Shoulder and Hand; Quick DASH), and active shoulder joint range of motion (ROM) angles at 1, 3, and 6 weeks after the injection. Means and standard deviations of were noted for each measurement period and each group. Improvements in each period between the groups and differences between the preinjection values and each follow-up period between the groups were analyzed using Ficher exact test, independent-samples t tests and Manova test. P < .05 was considered significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of the Shoulder
Keywords
adhesive capsulitis, steroid injection, ultrasound-guided

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who are diagnosed with adhesive capsulitis in the orthopedic outpatient clinic will be included. Included patients will be randomly divided into two groups according to age, sex, concomitant diabetes mellitus (DM) disease and clinical stage of the disease. For randomization, stratified randomization will be applied according to the information obtained from the outpatient clinic. While patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance.1 mL of triamcinolone acetonide and 1 mL of prilocaine hydrochloride (2%) will be injected to all patients. Patients will be first evaluated before injection, than randomized to groups and prospectively followed up by an orthopaedic surgeon who will be blinded to the groups. Evaluation will be done for pain VAS, functional status ;ASES and Quick DASH at 1,3 and 6 weeks after the injection.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
posterior intra-articular steroid injection under USG guidance
Arm Type
Active Comparator
Arm Description
Intra-articular steroid injection will be performed to the glenohumeral joint from the posterior, 2cm inferior and 2cm medial of the acromion posterolateral corner, under the guidance of USG.
Arm Title
anterior extra-articular steroid injection under USG guidance
Arm Type
Active Comparator
Arm Description
Steroid injection will be performed from the anterior, immediately lateral to the coracoid process, to the CHL localization, to the extra-articular area under the guidance of USG.
Intervention Type
Drug
Intervention Name(s)
A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)
Intervention Description
patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.
Primary Outcome Measure Information:
Title
The Visual Analogue Scale(VAS)
Description
The change of Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.We noted the changes within this scoring system between the time framed which is stated below
Time Frame
The change from the baseline of the Visual Analog Scale (VAS) score of the shoulder pain in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
Title
external rotation of shoulder
Description
The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer.
Time Frame
The change from the baseline of external rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
Title
abduction of shoulder
Description
The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer.
Time Frame
The change in shoulder abduction from the baseline over a 6-week period Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
Title
flexion of shoulder
Description
The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer.
Time Frame
The change from the baseline of flexion of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
Title
Internal rotation of the shoulder
Description
The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score
Time Frame
The change from the baseline of internal rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must be between the ages of 18-75 clinically and radiologically confirmed adhesive capsulitis Exclusion Criteria: Patients with a tear in any of the rotator cuff tendons Patients who have had steroid injections in the shoulder region before patients who have been treated with the diagnosis of adhesive capsulitis (except for oral non-steroidal anti-inflammatory drug therapy) Patients with a previous history of trauma-fracture-dislocation in the shoulder region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OMER FARUK SEVIM, MD
Phone
+905382884306
Email
dromerfaruksevim@gmail.com
Facility Information:
Facility Name
Kartal Dr Lutfi Kirdar City Hospital
City
Istanbul
State/Province
Kartal
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Faruk Sevim
Phone
+905382884306
Email
dromerfaruksevim@gmail.com
First Name & Middle Initial & Last Name & Degree
Selim Ergun
Phone
‭+90 533 601 14 72‬
Email
drselimergun@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the criteria specified and to be observed regarding the study will be transferred to the system in a timely manner and will be observed by the researchers outside the personal information of the patients.
IPD Sharing Time Frame
There will be no time limitations on data monitoring

Learn more about this trial

Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis.

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