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NCT Number: NCT07409779

Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis

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.

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Key information

Conditions

Adhesive Capsulitis of the Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medecine of Tunis

Tunis, Tunis Governorate, Tunisia

Location contact

Hiba Ben Ayed, Assistant professor

PRINCIPAL_INVESTIGATOR

Hiba Boussaa, assistant professor

PRINCIPAL_INVESTIGATOR

Houda Ajlani, Rheumatologist

PRINCIPAL_INVESTIGATOR

Ines Mahmoud, Professor

PRINCIPAL_INVESTIGATOR

Kawther Ben Abdelghani, Professor

PRINCIPAL_INVESTIGATOR

Leila Rouached, Assistant professor

PRINCIPAL_INVESTIGATOR

Leila Rouached, assistant professor

CONTACT

[email protected]

0021653482262

Olfa Jomaa, Assistant professor

PRINCIPAL_INVESTIGATOR

Rim Dhahri, Professor

PRINCIPAL_INVESTIGATOR

Saoussen Miladi, associate professor

PRINCIPAL_INVESTIGATOR

Yasmine Makhlouf, Assistant professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

capsular distension

Procedure

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

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.

Primary outcomes

  1. Shoulder Pain Intensity (Visual Analog Scale)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

  2. Shoulder range of motion

    Time frame: Baseline, 1 month, 3 months, and 6 months

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

  3. Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

Secondary outcomes

  1. Patient Satisfaction Score

    Time frame: 6 months

    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.

  2. Procedure-Related Complications

    Time frame: 1 month

    Occurrence of immediate or delayed complications related to the procedures.

  3. Rotator Cuff Interval Doppler Signal

    Time frame: Inclusion, 3 months ,6 months

    Presence of Doppler signal at the rotator cuff interval assessed by shoulder ultrasound, reported as present or absent.

  4. Coracohumeral Ligament Thickness

    Time frame: Baseline, 3 months, and 6 months

    Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.

  5. Glenohumeral Capsular Thickness

    Time frame: Baseline, 3 months, and 6 months

    Thickness of the glenohumeral joint capsule measured in millimeters using shoulder ultrasound at the axillary recess.

Sponsors and collaborators

Lead sponsor

Faculty of Medicine of Tunis

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Mar 25, 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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