Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adhesive Capsulitis of the Shoulder
• Intervention / Treatment: Procedure: capsular distension; Procedure: Betamethasone (Diprostene®) Injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis Governorate
    • Tunis, Tunis Governorate, Tunisia
      • Faculty of Medecine of Tunis
      • Contact: Leila Rouached, assistant professor; Phone Number: 0021653482262; Email: leila.rouached@fmt.utm.tn
      • Principal Investigator: Ines Mahmoud, Professor
      • Principal Investigator: Kawther Ben Abdelghani, Professor
      • Principal Investigator: Rim Dhahri, Professor
      • Principal Investigator: Saoussen Miladi, associate professor
      • Principal Investigator: Houda Ajlani, Rheumatologist
      • Principal Investigator: Leila Rouached, Assistant professor
      • Principal Investigator: Hiba Boussaa, assistant professor
      • Principal Investigator: Yasmine Makhlouf, Assistant professor
      • Principal Investigator: Olfa Jomaa, Assistant professor
      • Principal Investigator: Hiba Ben Ayed, Assistant professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsular Distension; Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program.	Procedure: capsular distension; Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
Experimental: Betamethasone (Diprostene®) injection; 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; Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score	Patient-reported satisfaction assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates not satisfied at all and 10 indicates completely satisfied with the treatment.	6 months
Procedure-Related Complications	Occurrence of immediate or delayed complications related to the procedures.	1 month
Rotator Cuff Interval Doppler Signal	Presence of Doppler signal at the rotator cuff interval assessed by shoulder ultrasound, reported as present or absent.	Inclusion, 3 months ,6 months
Coracohumeral Ligament Thickness	Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.	Baseline, 3 months, and 6 months
Glenohumeral Capsular Thickness	Thickness of the glenohumeral joint capsule measured in millimeters using shoulder ultrasound at the axillary recess.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Faculty of Medicine of Tunis

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; corticosteroid; adhesive capsulitis; capsular distension
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis; Therapeutics; Drug Administration Routes; Drug Therapy; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Betamethasone; Injections
• Other Study ID Numbers: CD-RCT-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD collected in this study will not be shared publicly. Data will be used exclusively by the study investigators for the purposes of this research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No