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Completed

NCT Number: NCT07710651

Pericapsular vs Intra-Articular Injection in Adhesive Capsulitis

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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Corticosteroid Injection Joint Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University- Cerrahpasa

Istanbul, Fatih, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betamethasone

Drug

Ultrasound-guided intra-articular injection of 1 mL betamethasone combined with 4 mL of 2% lidocaine.

Other names: Lidocaine

Primary outcomes

  1. Change in Constant-Murley Score

    Time frame: 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.

  2. Change in Numeric Rating Scale (NRS) pain score

    Time frame: 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 outcomes

  1. Change in Shoulder Disability Questionnaire (SDQ) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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