- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710651
Pericapsular vs Intra-Articular Injection in Adhesive Capsulitis
Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis
Adhesive capsulitis is a common and disabling shoulder disorder characterized by progressive pain and restricted active and passive range of motion, leading to significant limitations in daily activities and reduced quality of life. Corticosteroid injections are widely used to relieve pain and improve shoulder function; however, the optimal injection site remains a matter of debate. While ultrasound-guided intra-articular injections are considered a standard treatment, ultrasound-guided pericapsular injections have recently emerged as a potential alternative by targeting the inflamed capsular tissues directly.
The primary objective of this study is to compare the clinical effectiveness of ultrasound-guided pericapsular corticosteroid injection with ultrasound-guided intra-articular corticosteroid injection in patients diagnosed with adhesive capsulitis. The study aims to determine whether one injection technique provides superior improvements in pain, shoulder range of motion, functional status, and patient-reported outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fatih
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Istanbul, Fatih, Turkey (Türkiye), 34093
- Istanbul University- Cerrahpasa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Diagnosis of unilateral adhesive capsulitis, characterized by shoulder pain and restriction of both active and passive range of motion.
Exclusion Criteria:
- Secondary glenohumeral joint motion limitation due to inflammatory, degenerative, metabolic, or infectious arthritis.
- History of cerebrovascular accident (stroke).
- History of fracture involving the affected shoulder.
- Presence of any neurological deficit affecting the upper extremity.
- Previous surgery involving the affected shoulder.
- History of shoulder trauma.
- Pregnancy or breastfeeding.
- Known hypersensitivity or allergic reaction to local anesthetics or corticosteroids used in the study.
- Current use of anticoagulant therapy.
- Active inflammatory or infectious disease.
- Active psychiatric disorder.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- Uncompensated chronic heart, liver, or renal failure.
- Presence of vascular or malignant disease affecting the shoulder region.
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 |
|---|---|
|
Active Comparator: Intra-articular Group
Participants in the first group (IA group, n = 17) received an ultrasound-guided intra-articular injection.
A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure.
|
Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
Other Names:
Ultrasound-guided pericapsular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
Other Names:
|
|
Active Comparator: Pericapsular Group
Participants in the first group (IA group, n = 17) received an ultrasound-guided pericapsular injection.
A mixture of 4 mL of 2% lidocaine and 1 mL of betamethasone was administered for the injection procedure.
|
Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
Other Names:
Ultrasound-guided pericapsular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Constant-Murley Score
Time Frame: Baseline, Week 1, Week 4, and Month 3
|
The Constant-Murley Score (CMS) is a validated, clinician-administered instrument used to assess shoulder function.
It consists of four domains: pain (15 points), activities of daily living (20 points), range of motion (40 points), and muscle strength (25 points), yielding a total score ranging from 0 to 100.
Higher scores indicate better shoulder function and less disability.
Changes in the CMS from baseline to each follow-up visit will be used to evaluate treatment effectiveness.
|
Baseline, Week 1, Week 4, and Month 3
|
|
Change in Numeric Rating Scale (NRS) pain score
Time Frame: Baseline,1-Hour, Week 1, Week 4, and Month 3
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point patient-reported scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
Participants will rate their pain at rest, during the night, and during activity.
Changes in NRS scores from baseline to each follow-up visit will be used to evaluate the effectiveness of the interventions in reducing pain.
|
Baseline,1-Hour, Week 1, Week 4, and Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Shoulder Disability Questionnaire (SDQ) score
Time Frame: Baseline, Week 1, Week 4, and Month 3
|
The Shoulder Disability Questionnaire (SDQ) is a validated patient-reported outcome measure used to assess pain-related functional disability in individuals with shoulder disorders.
It consists of 16 items evaluating limitations in daily activities experienced during the previous 24 hours.
The total score ranges from 0 to 100, with higher scores indicating greater shoulder-related disability.
Changes in SDQ scores from baseline to each follow-up visit will be used to assess the effectiveness of the interventions in improving shoulder function and reducing disability.
|
Baseline, Week 1, Week 4, and Month 3
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Buchbinder R, Hoving JL, Green S, Hall S, Forbes A, Nash P. Short course prednisolone for adhesive capsulitis (frozen shoulder or stiff painful shoulder): a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Nov;63(11):1460-9. doi: 10.1136/ard.2003.018218.
- Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
- Sharif M, Khan MS, Ahmed TK, Aziz W, Rasheed U, Zammurrad S, Iqbal A, Mumtaz H, Hussain HU, Hasan M, Erum S. Comparison of efficacy three-site versus single-site steroid injections for the treatment of adhesive capsulitis. Ann Med Surg (Lond). 2022 Jun 28;79:104071. doi: 10.1016/j.amsu.2022.104071. eCollection 2022 Jul.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- E-83045809-604.01.01-539366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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