Adhesive Capsulitis, Corticosteroid Injection
Conditions
Keywords
Ultrasound-Guided Injection, Pericapsular Injection, Intra-Articular Injection, Glenohumeral Joint
Brief summary
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.
Interventions
DRUGBetamethasone
Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective double-blinded, randomized trial was performed in patients with AC who were followed at the physical medicine and rehabilitation department of our university hospital.Thirty-four (n = 34) patients between the ages of 18 and 70, having unilateral shoulder pain with limitation of both active and passive range of motion (ROM) of the shoulder joint and diagnosed as AC were enrolled in our study. Thirty-four patients (18 women, 16 men) having a diagnosis of AC and who met the inclusion criteria were randomized into 2 groups. The block randomization method was used for the randomization of the patients who were also blinded to group allocation. Same physiatrist generated the random allocation sequence, enrolled participants, and assigned participants to interventions. In the first group (IA group) (n=17) US guided intraarticular injection was applied while in the second group (LA group) (n=17) US guided pericapsular injection was performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Constant-Murley Score | 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. |
| Change in Numeric Rating Scale (NRS) pain score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shoulder Disability Questionnaire (SDQ) score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed