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Not yet recruiting NCT07364227

Anterior vs Posterior vs Combined Intra-Articular Injections for Adhesive Capsulitis

No phase Interventional Adhesive Capsulitis of the Shoulder Intra Articular Injection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention Name: Posterior Intra-articular Injection, Anterior Intra-articular Injection, Combined Anterior + Posterior Intra-articular Injection.
Who it may be relevant to
Registry conditions: Adhesive Capsulitis of the Shoulder, Intra Articular Injection. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Anterior, Posterior, and Combined Intra-Articular Injection Techniques in Patients With Adhesive Capsulitis

Overview

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

  • Drug Intervention 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.
  • Drug Anterior 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.
  • Drug Combined 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.

Primary outcome measures

  • Change in Shoulder Range of Motion (ROM) [Time frame: Baseline, immediately post-injection, week 3, week 6, week 12]
Secondary outcome measures (8)
  • Change in Pain Intensity (NRS) [Time frame: Baseline, immediately post-injection, week 3, week 6, week 12]
  • Subjective Shoulder Value (SSV) [Time frame: Baseline, immediately post-injection, week 3, week 6, week 12]
  • Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline, week 3, week 6, week 12]
  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) [Time frame: Baseline, week 3, week 6, week 12]
  • American Shoulder and Elbow Surgeons (ASES) Score [Time frame: Baseline, week 3, week 6, week 12]
  • Constant-Murley Shoulder Score [Time frame: Baseline, week 3, week 6, week 12]
  • Scratch Test Score [Time frame: Baseline, immediately post-injection, week 3, week 6, week 12]
  • Axillary Capsule Thickness (Ultrasound) [Time frame: Baseline, immediately post-injection (only).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07364227 · ADC2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗