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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Posterior Injection | Experimental | Single intra-articular injection with corticosteroid + lidocaine + saline via the posterior glenohumeral approach. |
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| Arm B - Anterior Injection | Experimental | Same injection solution administered via the anterior (rotator interval) approach. |
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| Arm C - Combined Anterior + Posterior Injection | Experimental | Same injection solution administered using both anterior and posterior approaches. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Name: Posterior Intra-articular Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Range of Motion (ROM) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity (NRS) | 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) |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aslinur K Keles, MD., PhD | Contact | +905395010707 | aslinur.ercisli@gmail.com | |
| esra K giray, Assoc Prof | Contact | +90 555 813 43 94 | girayesra@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aslinur keles, MD., PhD | Health Sciences University Fatih Sultan Mehmet Training and Research Hospital | Principal Investigator |
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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.
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| Anterior Intra-articular Injection | Drug | 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. |
|
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| Combined Anterior + Posterior Intra-articular Injection | Drug | 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. |
|
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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) | 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) | 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 | Composite score including pain and function (0-100, higher = better). | Baseline, week 3, week 6, week 12 |
| Constant-Murley Shoulder Score | Clinical score combining pain, activities of daily living, strength, and ROM (0-100). | Baseline, week 3, week 6, week 12 |
| Scratch Test Score | 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) | Ultrasound measurement of axillary recess capsule thickness on the affected shoulder. | Baseline, immediately post-injection (only). |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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