Adhesive CapsulitisIRCAPNCT04653636
MRI and Clinical Predictive Factors of the Response to Arthrographic Distension in Severe Capsulitis
An observational study of Adhesive Capsulitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to identify clinical and MRI factors associated to a better response to arthrographic distension in patients with severe capsulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Arthrographic distension and Immediate joint mobilization
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2020to 14 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective.
Who may be able to join
- Age greater than or equal to 18 years,
- Symptomatic shoulder (pain or stiffness) for at least 3 months.
- Patient with failure of treatment including at least NSAIDs, analgesics, +/- intra-articular corticosteroid infiltration and physiotherapy.
- Painful shoulder at inclusion (EN > 5)
- Limitation of passive amplitudes of the glenohumeral joint, of at least 25% of 2 of the 3 mobility sectors (lateral arm elevation, anterior elevation and lateral rotation in the RE1 position), compared to the opposite side
- Absence of glenohumeral arthropathy and abarticular calcification on the standard x-ray of both shoulders.
- Affiliation to a social security
- Information and collection of patient consent
Who cannot join
- Obtain patient consent impossible
- Cognitive disorders considered moderate to severe by the investigator
- Unbalanced diabetes mellitus (glycated hemoglobin> 10%)
- Anticoagulant treatment that cannot be interrupted
- Hemostatic disorders (known history, platelet count <120,000, prothrombin level <75%)
- Allergy to xylocaine, Gadolinium, Diprostene
Show all 11Show fewer
- Biological inflammatory syndrome
- Pregnant woman (beta human chorionic gonadotropin dosage) or breastfeeding
- Language barrier to the integration of a rehabilitation program or the performance of a reliable assessment.
- People under protective measures
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
Paris, IDF, 75014
About this study
Official title: Clinical and MRI Predictive Factors of the Response to Arthrographic Distension and Intensive Physiotherapy in Severe Capsulitis: Improvement of Pain and Function at 1 Month
The purpose of this study is to identify clinical and MRI factors associated to a better response to arthrographic distension in patients with severe capsulitis.
Read the detailed description
Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital for severe adhesive capsulitis for whom first-line medical treatment is not effective. The first-line treatment including analgesic, NSAIDs and / or intra-articular infiltration of a corticosteroid derivative and multi-weekly physiotherapy
These patients are integrated into a usual protocol (routine care) consisting of performing an MRI with intravenous injection of gadolinium to confirm the diagnostic and eliminated others causes of shoulder stiffness. IV gadolinium-enhanced MRI can increase the performance of the signal analysis changes of the Synovium and capsule in the Axillary Recess and Rotator interval as compared with unenhanced measures The treatment consists in one to three arthrographic distensions by physiological serum, xylocaine 1% and injection of an ampoule of corticosteroids (DIPROSTENE) associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor). The primary objective of arthrographic distension is the expansion and rupture of the glenohumeral capsule in the subscapularis recess. It consists after local anesthesia, in an injection under pressure of air or liquid - opacifier or physiological serum - in the glenohumeral joint associated with an infiltration of cortisone derivatives at the end of the operation. Physical treatment aimed at rapid amplitude gain is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthro-distension may be repeated once or twice during the mobilization period.
- Conditions
- Adhesive Capsulitis
- Being tested
- Arthrographic distension, Immediate joint mobilization
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrographic distensionOther
Also called Shoulder joint capsule arthrographic distension
The treatment consists in one to three shoulder joint capsule arthrographic distension. It consists after local anesthesia, in an injection under pressure of xylocaine 1% and physiological serum in the glenohumeral joint associated with an ampoule of corticosteroids (Betamethasone or Triamcinolone hexacetonide ) at the end of the operation.
- first arthrographic distension is performed under scopic guidance
- second and/or third arthrographic distension are performed under ultrasound guidance
Immediate joint mobilizationOther
Also called Intensive mobilization
This procedure was associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor).
Physical treatment aimed at rapid amplitude gain and is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthrographic distension may be repeated once or twice during the mobilization period.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive capsulitis | Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective. Receives: Other: Arthrographic distension; Other: Immediate joint mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Impairment: numeric verbal scale of pain
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
Measured: 1 month
Secondary outcomes (8)
Physical Impairment: numeric verbal scale of night pain
self-evaluated numeric verbal scale of night pain ranging from 0 to 10 (lesser is better)
Measured: 1 month
Physical Impairment: numeric verbal scale of maximum pain
self-evaluated numeric verbal scale of maximum pain ranging from 0 to 10 (lesser is better)
Measured: 1 month
Disability : numeric verbal scale of disability
self-evaluated numeric verbal scale of disability ranging from 0 to 10 (lesser is better)
Measured: 1 month
Physical Impairment : mobility of shoulder joints
mobility and rotation
Measured: 1 month
Psychological Impairment : Hospital Anxiety and Depression Scale (HADS)
Questionnaire possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21.
Measured: 1 month
Fear-Avoidance Beliefs Questionnaire (FABQ)
Patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work.
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs There are two subscales; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24).
Measured: 1 month
Shoulder Pain and Disability Index (SPADI)
self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Total score ranging from 0 (best) to 100 (worst).
Measured: 1 month
Disabilities of the Arm, Shoulder and Hand (DASH)
Self-administered questionnaire assessing quality of life of the upper limb. It assesses the ability to perform 23 activities, the severity of symptoms 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales.
Scores range from 0 (no disability) to 100 (most severe disability). In addition there are two optional modules of four questions each, sporting or instrumental and employment activity.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start9 Oct 2020
- Primary completion21 Oct 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Martine LEFEVRE-COLAU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653636
- Sponsor's protocol ID
- APHP190073
- Acronym
- IRCAP
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and MRI Predictive Factors of the Response to Arthrographic Distension and Intensive Physiotherapy in Severe Capsulitis: Improvement of Pain and Function at 1 Month
- ClinicalTrials.gov ID
- NCT04653636
- Acronym / sponsor ID
- IRCAP / APHP190073
- Conditions
- Adhesive Capsulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 4 Dec 2020 (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.
The purpose of this study is to identify clinical and MRI factors associated to a better response to arthrographic distension in patients with severe capsulitis.
Detailed description
Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital for severe adhesive capsulitis for whom first-line medical treatment is not effective. The first-line treatment including analgesic, NSAIDs and / or intra-articular infiltration of a corticosteroid derivative and multi-weekly physiotherapy
These patients are integrated into a usual protocol (routine care) consisting of performing an MRI with intravenous injection of gadolinium to confirm the diagnostic and eliminated others causes of shoulder stiffness. IV gadolinium-enhanced MRI can increase the performance of the signal analysis changes of the Synovium and capsule in the Axillary Recess and Rotator interval as compared with unenhanced measures The treatment consists in one to three arthrographic distensions by physiological serum, xylocaine 1% and injection of an ampoule of corticosteroids (DIPROSTENE) associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor). The primary objective of arthrographic distension is the expansion and rupture of the glenohumeral capsule in the subscapularis recess. It consists after local anesthesia, in an injection under pressure of air or liquid - opacifier or physiological serum - in the glenohumeral joint associated with an infiltration of cortisone derivatives at the end of the operation. Physical treatment aimed at rapid amplitude gain is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthro-distension may be repeated once or twice during the mobilization period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adhesive capsulitis | – | Other: Arthrographic distension, Other: Immediate joint mobilizationPatients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital with a clinically diagnosis of severe adhesive capsulitis for whom first-line medical treatment is not effective.
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 years,
- Symptomatic shoulder (pain or stiffness) for at least 3 months.
- Patient with failure of treatment including at least NSAIDs, analgesics, +/- intra-articular corticosteroid infiltration and physiotherapy.
- Painful shoulder at inclusion (EN > 5)
- Limitation of passive amplitudes of the glenohumeral joint, of at least 25% of 2 of the 3 mobility sectors (lateral arm elevation, anterior elevation and lateral rotation in the RE1 position), compared to the opposite side
Key exclusion criteria (11 listed)
- Obtain patient consent impossible
- Cognitive disorders considered moderate to severe by the investigator
- Unbalanced diabetes mellitus (glycated hemoglobin> 10%)
- Anticoagulant treatment that cannot be interrupted
- Hemostatic disorders (known history, platelet count <120,000, prothrombin level <75%)
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 |
|---|---|---|
| Arthrographic distensionAlso: Shoulder joint capsule arthrographic distensionThe treatment consists in one to three shoulder joint capsule arthrographic distension. It consists after local anesthesia, in an injection under pressure of xylocaine 1% and physiological serum in the glenohumeral joint associated with an ampoule of corticosteroids (Betamethasone or Triamcinolone hexacetonide ) at the end of the operation. * first arthrographic distension is performed under scopic guidance * second and/or third arthrographic distension are performed under ultrasound guidance | Other | Adhesive capsulitis |
| Immediate joint mobilizationAlso: Intensive mobilizationThis procedure was associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor). Physical treatment aimed at rapid amplitude gain and is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthrographic distension may be repeated once or twice during the mobilization period. | Other | Adhesive capsulitis |
Primary outcome
Physical Impairment: numeric verbal scale of pain
Time frame: 1 month
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
8 secondary outcomes
Physical Impairment: numeric verbal scale of night pain
Time frame: 1 month
Physical Impairment: numeric verbal scale of maximum pain
Time frame: 1 month
Disability : numeric verbal scale of disability
Time frame: 1 month
Physical Impairment : mobility of shoulder joints
Time frame: 1 month
Psychological Impairment : Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 month
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 1 month
Shoulder Pain and Disability Index (SPADI)
Time frame: 1 month
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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. This study is not recruiting at the moment.
Marie-Martine LEFEVRE-COLAU, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Capsulitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 12 Sep 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Impairment: numeric verbal scale of pain (time frame: 1 month). 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 12 Sep 2025.