Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis

March 21, 2026 updated by: Faculty of Medicine of Tunis

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunisia
        • Faculty of Medecine of Tunis
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 3 months, and 6 months
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.
Baseline, 1 month, 3 months, and 6 months
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.
Baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months
Procedure-Related Complications
Time Frame: 1 month
Occurrence of immediate or delayed complications related to the procedures.
1 month
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.
Inclusion, 3 months ,6 months
Coracohumeral Ligament Thickness
Time Frame: Baseline, 3 months, and 6 months
Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculty of Medicine of Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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