NCT Number: NCT07364227
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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: 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 anterior (rotator interval) approach.
Other names: Anterior hydrodilatation
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: combined joint injection
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.
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.
Time frame: Baseline, immediately post-injection, week 3, week 6, week 12
Patient's self-reported percentage of normal shoulder function (0-100%).
Time frame: Baseline, week 3, week 6, week 12
Questionnaire assessing pain and disability (0-100 score, higher scores = worse function).
Time frame: Baseline, week 3, week 6, week 12
Questionnaire measuring upper limb disability and symptoms (0-100 score, higher = worse).
Time frame: Baseline, week 3, week 6, week 12
Composite score including pain and function (0-100, higher = better).
Time frame: Baseline, week 3, week 6, week 12
Clinical score combining pain, activities of daily living, strength, and ROM (0-100).
Time frame: Baseline, immediately post-injection, week 3, week 6, week 12
Functional test measuring the patient's ability to reach behind the back.
Time frame: Baseline, immediately post-injection (only).
Ultrasound measurement of axillary recess capsule thickness on the affected shoulder.
Contact information is provided by the study sponsor or research team.
Aslinur K Keles, MD., PhD
CONTACT
esra K giray, Assoc Prof
CONTACT
Aslinur Keles Ercisli, MD, PhD
Other
Comparison of Anterior, Posterior, and Combined Intra-Articular Injection Techniques in Patients With Adhesive Capsulitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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