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Not yet recruiting NCT07409779

Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis

No phase Interventional Adhesive Capsulitis of the Shoulder

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: capsular distension, Betamethasone (Diprostene®) Injection.
Who it may be relevant to
Registry conditions: Adhesive Capsulitis of the Shoulder. Basic parameters: 18 years — 80 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
Tunisia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Capsular Distension Versus Corticosteroid Injection in Patients With Adhesive Capsulitis: A Randomized Controlled Trial

Overview

Adhesive capsulitis is a common and disabling shoulder condition characterized by pain and progressive limitation of range of motion. Capsular distension and intra-articular corticosteroid injection are commonly used therapeutic options, often combined with rehabilitation, but their comparative effectiveness remains debated. The objective of this randomized controlled trial is to compare the efficacy and tolerance of ultrasound-guided capsular distension combined with rehabilitation versus intra-articular corticosteroid injection combined with rehabilitation in patients with adhesive capsulitis. Outcomes will include shoulder pain, range of motion, functional disability, patient satisfaction, and procedure-related complications, assessed at short, mid, and long-term follow-up.

Interventions

  • Procedure capsular distension
    Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
  • Procedure Betamethasone (Diprostene®) Injection
    Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.

Primary outcome measures

  • Shoulder Pain Intensity (Visual Analog Scale) [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Shoulder range of motion [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline, 1 month, 3 months, and 6 months]
Secondary outcome measures (5)
  • Patient Satisfaction Score [Time frame: 6 months]
  • Procedure-Related Complications [Time frame: 1 month]
  • Rotator Cuff Interval Doppler Signal [Time frame: Inclusion, 3 months ,6 months]
  • Coracohumeral Ligament Thickness [Time frame: Baseline, 3 months, and 6 months]
  • Glenohumeral Capsular Thickness [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 80 years
  • Ability to provide informed consent
  • Shoulder pain with Visual Analog Scale (VAS) ≥ 40/100
  • Limitation of external rotation < 45° or < 50% compared to the contralateral side
  • Clinically diagnosed adhesive capsulitis with normal shoulder radiography

Exclusion criteria

  • Rotator cuff tear
  • Previous shoulder surgery
  • Cervico-brachial neuralgia
  • Pregnancy or breastfeeding
  • Poorly controlled diabetes
  • Coagulation disorders or anticoagulant therapy with INR > 3
  • Allergy to lidocaine
  • Inflammatory rheumatic diseases
  • Severe cardiovascular or hematological diseases
  • Active infection or immunodeficiency
  • Severe psychiatric disorders
  • Recent shoulder rehabilitation (within 1 week)
  • Intra-articular corticosteroid injection or hyaluronic acid injection within the last 6 months
  • Refusal to sign informed consent

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
Double blind
Primary purpose
Treatment

Study locations

Tunisia · 1 center
  • Faculty of Medecine of Tunis — Tunis

Identifiers

NCT: NCT07409779 · CD-RCT-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗