Adhesive Capsulitis of the Shoulder, Intra Articular Injection
Conditions
Keywords
Adhesive Capsulitis of the Shoulder, Intra-articular Injection, Frozen Shoulder, Ultrasound, Shoulder Pain
Brief summary
This randomized controlled clinical trial aims to compare the efficacy of three different intra-articular injection approaches (anterior, posterior, and combined anterior-posterior) in patients with adhesive capsulitis of the shoulder. Thirty participants will be randomly assigned to one of three groups and treated with a standardized injection solution consisting of corticosteroid, lidocaine, and saline. Clinical outcomes will be evaluated using pain scores, functional scales, and imaging parameters.
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.
Interventions
DRUGIntervention Name: Posterior Intra-articular Injection
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.
DRUGAnterior Intra-articular Injection
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.
DRUGCombined Anterior + Posterior Intra-articular Injection
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.
Sponsors
Aslinur Keles Ercisli, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center, randomized, controlled, parallel-group clinical trial with three intervention arms. Thirty patients with adhesive capsulitis will be randomly assigned in equal numbers (1:1:1) to receive an intra-articular corticosteroid injection via the posterior approach, the anterior approach, or a combined anterior-posterior approach. Each participant will receive only one type of injection, and outcomes will be assessed at baseline, immediately post-injection, and at weeks 3, 6, and 12.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Age 18-70 years Unilateral shoulder pain and stiffness (symptom duration 1-9 months) NRS pain score ≥ 7/10 Passive range of motion limitation \>50% in at least two planes, or \>30° restriction in ≥2 planes "Freezing stage" (stage 2 adhesive capsulitis) No analgesic use (NSAIDs, opioids, acetaminophen) within 12 hours before intervention Radiography and/or MRI excluding other pathologies (rotator cuff tear, labral lesion, osteoarthritis, etc.)
Exclusion criteria
Secondary adhesive capsulitis (trauma, surgery, systemic disease) Prior shoulder surgery or intra-articular steroid injection within 3 months Bilateral frozen shoulder Neurological disorders (Parkinson's disease, ALS, neuropathies) Malignancy, infection, cellulitis, septic arthritis, acute fracture Cognitive impairment, psychiatric disorders, pregnancy Steroid or local anesthetic allergy Poor glycemic control or other contraindications to steroid injections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shoulder Range of Motion (ROM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (NRS) | Baseline, immediately post-injection, week 3, week 6, week 12 | Number Rating Scale (0-10) for pain at rest, during activity, and at night. |
| Subjective Shoulder Value (SSV) | Baseline, immediately post-injection, week 3, week 6, week 12 | Patient's self-reported percentage of normal shoulder function (0-100%). |
| Shoulder Pain and Disability Index (SPADI) | Baseline, week 3, week 6, week 12 | Questionnaire assessing pain and disability (0-100 score, higher scores = worse function). |
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) | Baseline, week 3, week 6, week 12 | Questionnaire measuring upper limb disability and symptoms (0-100 score, higher = worse). |
| American Shoulder and Elbow Surgeons (ASES) Score | Baseline, week 3, week 6, week 12 | Composite score including pain and function (0-100, higher = better). |
| Constant-Murley Shoulder Score | Baseline, week 3, week 6, week 12 | Clinical score combining pain, activities of daily living, strength, and ROM (0-100). |
| Scratch Test Score | Baseline, immediately post-injection, week 3, week 6, week 12 | Functional test measuring the patient's ability to reach behind the back. |
| Axillary Capsule Thickness (Ultrasound) | Baseline, immediately post-injection (only). | Ultrasound measurement of axillary recess capsule thickness on the affected shoulder. |
Contacts
CONTACTAslinur K Keles, MD., PhD
CONTACTesra K giray, Assoc Prof
PRINCIPAL_INVESTIGATORAslinur keles, MD., PhD
Health Sciences University Fatih Sultan Mehmet Training and Research Hospital
Outcome results
None listed