Adhesive Capsulitis of the ShoulderNCT07409779
Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis
A study testing capsular distension and Betamethasone (Diprostene®) Injection in people with Adhesive Capsulitis of the Shoulder, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- capsular distension and Betamethasone (Diprostene®) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Rotator cuff tear
- Previous shoulder surgery
- Cervico-brachial neuralgia
- Pregnancy or breastfeeding
- Poorly controlled diabetes
- Coagulation disorders or anticoagulant therapy with INR > 3
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Faculty of Medecine of Tunis
Tunis, Tunis Governorate
Leila Rouached, assistant professor, 0021653482262, leila.rouached@fmt.utm.tn
Ines Mahmoud, Professor
About this study
Official title: 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.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- capsular distension, Betamethasone (Diprostene®) Injection
- Keywords
- adhesive capsulitis, capsular distension, rehabilitation, corticosteroid
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsular distensionProcedure or surgery
Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
Betamethasone (Diprostene®) InjectionProcedure or surgery
Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Capsular Distension | Experimental | Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program. Receives: 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. Receives: Procedure: Betamethasone (Diprostene®) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Procedure-Related Complications
Occurrence of immediate or delayed complications related to the procedures.
Measured: 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.
Measured: Inclusion, 3 months ,6 months
Coracohumeral Ligament Thickness
Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409779
- Sponsor's protocol ID
- CD-RCT-2026
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsular Distension Versus Corticosteroid Injection in Patients With Adhesive Capsulitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07409779
- Acronym / sponsor ID
- CD-RCT-2026
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- adhesive capsulitis, capsular distension, rehabilitation, corticosteroid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsular Distension | Experimental | Procedure: capsular distensionUltrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program. |
| Betamethasone (Diprostene®) injection | Experimental | Procedure: Betamethasone (Diprostene®) InjectionUltrasound-guided intra-articular injection of betamethasone (Diprostene®) into the glenohumeral joint, performed under sterile conditions, followed by a standardized rehabilitation program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Rotator cuff tear
- Previous shoulder surgery
- Cervico-brachial neuralgia
- Pregnancy or breastfeeding
- Poorly controlled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capsular distensionUltrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program. | Procedure or surgery | Capsular Distension |
| Betamethasone (Diprostene®) InjectionUltrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program. | Procedure or surgery | Betamethasone (Diprostene®) injection |
Primary outcome
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.
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsular distension and Betamethasone (Diprostene®) Injection in people with Adhesive Capsulitis of the Shoulder, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain Intensity (Visual Analog Scale) (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.