Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis

NCT07409779 | Not Yet Recruiting DMC

• 1 other identifier: CD-RCT-2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis of the Shoulder

Keywords

adhesive capsulitis; capsular distension; rehabilitation; corticosteroid

Outcome Measures

Primary Outcomes (3)

• Shoulder Pain Intensity (Visual Analog Scale)

  Change in shoulder pain intensity assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.

  Baseline, 1 month, 3 months, and 6 months

• Shoulder range of motion

  Change in active shoulder range of motion measured in degrees, including external rotation, internal rotation, abduction, and forward elevation.

  Baseline, 1 month, 3 months, and 6 months

• Shoulder Pain and Disability Index (SPADI)

  Change in shoulder pain and disability assessed using the Shoulder Pain and Disability Index (SPADI), a validated 13-item questionnaire scored from 0 to 100, with higher scores indicating greater pain and disability.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (5)

• Patient Satisfaction Score

  6 months

• Procedure-Related Complications

  1 month

• Rotator Cuff Interval Doppler Signal

  Inclusion, 3 months ,6 months

• Coracohumeral Ligament Thickness

  Baseline, 3 months, and 6 months

• Glenohumeral Capsular Thickness

  Baseline, 3 months, and 6 months

Study Arms (2)

Capsular Distension

EXPERIMENTAL

Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program.

Procedure: capsular distension

Betamethasone (Diprostene®) injection

EXPERIMENTAL

Ultrasound-guided intra-articular injection of betamethasone (Diprostene®) into the glenohumeral joint, performed under sterile conditions, followed by a standardized rehabilitation program.

Procedure: Betamethasone (Diprostene®) Injection

Interventions

capsular distension PROCEDURE

Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.

Capsular Distension

Betamethasone (Diprostene®) Injection PROCEDURE

Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.

Betamethasone (Diprostene®) injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine of Tunis: lead

Study Sites (1)

Faculty of Medecine of Tunis

Tunis, Tunis Governorate, Tunisia

Location

MeSH Terms

Conditions

Bursitis

Interventions

Betamethasone; Injections

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)