- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364227
Anterior vs Posterior vs Combined Intra-Articular Injections for Adhesive Capsulitis
Comparison of Anterior, Posterior, and Combined Intra-Articular Injection Techniques in Patients With Adhesive Capsulitis
Study Overview
Status
Detailed Description
Adhesive capsulitis (frozen shoulder) is a disabling condition characterized by progressive pain and stiffness of the glenohumeral joint. Intra-articular corticosteroid injections are frequently used to reduce pain and improve mobility; however, the optimal injection approach remains controversial.
This single-center randomized controlled trial will investigate three different approaches: posterior, anterior, and combined anterior-posterior injections. The primary endpoint is improvement in active and passive range of motion. Secondary endpoints include pain scores (VAS), functional outcome measures (SPADI, qDASH, ASES, Constant-Murley, Scratch Test, Subjective Shoulder Value), and ultrasound evaluation of axillary capsule thickness. Assessments will be performed at baseline, immediately after injection, and at weeks 3, 6, and 12.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aslinur K Keles, MD., PhD
- Phone Number: +905395010707
- Email: aslinur.ercisli@gmail.com
Study Contact Backup
- Name: esra K giray, Assoc Prof
- Phone Number: +90 555 813 43 94
- Email: girayesra@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A: Posterior Injection
Single intra-articular injection with corticosteroid + lidocaine + saline via the posterior glenohumeral approach.
|
A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the posterior glenohumeral approach.
Other Names:
|
|
Experimental: Arm B - Anterior Injection
Same injection solution administered via the anterior (rotator interval) approach.
|
A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the anterior (rotator interval) approach.
Other Names:
|
|
Experimental: Arm C - Combined Anterior + Posterior Injection
Same injection solution administered using both anterior and posterior approaches.
|
A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered using both anterior and posterior approaches during the same procedure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Shoulder Range of Motion (ROM)
Time Frame: Baseline, immediately post-injection, week 3, week 6, week 12
|
Change in active and passive shoulder joint range of motion (flexion, extension, abduction, external rotation, internal rotation) measured with a goniometer.
|
Baseline, immediately post-injection, week 3, week 6, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity (NRS)
Time Frame: Baseline, immediately post-injection, week 3, week 6, week 12
|
Number Rating Scale (0-10) for pain at rest, during activity, and at night.
|
Baseline, immediately post-injection, week 3, week 6, week 12
|
|
Subjective Shoulder Value (SSV)
Time Frame: Baseline, immediately post-injection, week 3, week 6, week 12
|
Patient's self-reported percentage of normal shoulder function (0-100%).
|
Baseline, immediately post-injection, week 3, week 6, week 12
|
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline, week 3, week 6, week 12
|
Questionnaire assessing pain and disability (0-100 score, higher scores = worse function).
|
Baseline, week 3, week 6, week 12
|
|
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: Baseline, week 3, week 6, week 12
|
Questionnaire measuring upper limb disability and symptoms (0-100 score, higher = worse).
|
Baseline, week 3, week 6, week 12
|
|
American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Baseline, week 3, week 6, week 12
|
Composite score including pain and function (0-100, higher = better).
|
Baseline, week 3, week 6, week 12
|
|
Constant-Murley Shoulder Score
Time Frame: Baseline, week 3, week 6, week 12
|
Clinical score combining pain, activities of daily living, strength, and ROM (0-100).
|
Baseline, week 3, week 6, week 12
|
|
Scratch Test Score
Time Frame: Baseline, immediately post-injection, week 3, week 6, week 12
|
Functional test measuring the patient's ability to reach behind the back.
|
Baseline, immediately post-injection, week 3, week 6, week 12
|
|
Axillary Capsule Thickness (Ultrasound)
Time Frame: Baseline, immediately post-injection (only).
|
Ultrasound measurement of axillary recess capsule thickness on the affected shoulder.
|
Baseline, immediately post-injection (only).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aslinur keles, MD., PhD, Health Sciences University Fatih Sultan Mehmet Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADC2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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