Shoulder CapsulitisPhase 3CAPSULITENCT00724113
ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis
A Phase 3 study testing infiltration intra articular and ARTHRO distension plus intensive mobilisation in people with Shoulder Capsulitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Capsulitis
- What is being tested?
- infiltration intra articular and ARTHRO distension plus intensive mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jul 2014
- Phase
- Phase 3
- 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
Who may be able to join
- age ≥ 18 years
- shoulder capsulitis
- duration of symptoms ≥ 3 months
- health insurance
Who cannot join
- cognitive disorders
- Hypo coagulation
- biological inflammatory syndrome
- uncontrolled diabetes
- XYLOCAINE allergy
- pregnancy
Show all 10Show fewer
- unable to understand and to speak french
- previous surgery of shoulder
- shoulder infiltration or distension in the previous month
- local contraindication to shoulder infiltration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
Read the detailed description
The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.
- Conditions
- Shoulder Capsulitis
- Being tested
- infiltration intra articular, ARTHRO distension plus intensive mobilisation
- Keywords
- Shoulder capsulitis, ARTHRO distension, Mobilisation, Randomised clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration intra articularProcedure or surgery
Also called infiltration intra articular at inclusion with XYLOCAINE 1%
infiltration intra articular at inclusion with XYLOCAINE 1%
ARTHRO distension plus intensive mobilisationProcedure or surgery
ARTHRO distension plus intensive mobilisation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | infiltration intra articular Receives: Procedure: infiltration intra articular |
| 2 | Experimental | ARTHRO distension plus intensive mobilisation Receives: Procedure: ARTHRO distension plus intensive mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and disability using SPADI score at 2 weeks
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionAug 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johann Beaudreuil, PH MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724113
- Sponsor's protocol ID
- P051039
- Acronym
- CAPSULITE
- Status last verified
- May 2014
- First submitted
- 9 Apr 2008
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacob L, Lasbleiz S, Sanchez K, Morchoisne O, Lefevre-Colau MM, Nguyen C, Rannou F, Feydy A, Portal JJ, Schnitzler A, Vicaut E, Laredo JD, Richette P, Orcel P, Beaudreuil J. Arthro-distension with early and intensive mobilization for shoulder adhesive capsulitis: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Sep;67(6):101852. doi: 10.1016/j.rehab.2024.101852. Epub 2024 Jun 1.
PubMed 38824872
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
- ClinicalTrials.gov ID
- NCT00724113
- Acronym / sponsor ID
- CAPSULITE / P051039
- Conditions
- Shoulder Capsulitis
- Keywords
- Shoulder capsulitis, ARTHRO distension, Mobilisation, Randomised clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Jul 2008 (estimated)
- 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 evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
Detailed description
The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: infiltration intra articularinfiltration intra articular |
| 2 | Experimental | Procedure: ARTHRO distension plus intensive mobilisationARTHRO distension plus intensive mobilisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- shoulder capsulitis
- duration of symptoms ≥ 3 months
- health insurance
Key exclusion criteria (10 listed)
- cognitive disorders
- Hypo coagulation
- biological inflammatory syndrome
- uncontrolled diabetes
- XYLOCAINE allergy
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 |
|---|---|---|
| infiltration intra articularAlso: infiltration intra articular at inclusion with XYLOCAINE 1%infiltration intra articular at inclusion with XYLOCAINE 1% | Procedure or surgery | 1 |
| ARTHRO distension plus intensive mobilisationARTHRO distension plus intensive mobilisation | Procedure or surgery | 2 |
Primary outcome
Pain and disability using SPADI score at 2 weeks
Time frame: at 2 weeks
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 4 Jan 2017.
- Derived from this study: PubMed 38824872Jacob L, Lasbleiz S, Sanchez K, Morchoisne O, Lefevre-Colau MM, Nguyen C, Rannou F, Feydy A, Portal JJ, Schnitzler A, Vicaut E, Laredo JD, Richette P, Orcel P, Beaudreuil J. Arthro-distension with early and intensive mobilization for shoulder adhesive capsulitis: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Sep;67(6):101852. doi: 10.1016/j.rehab.2024.101852. Epub 2024 Jun 1.
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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. This study is not recruiting at the moment.
Johann Beaudreuil, PH MD 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?
A Phase 3 study testing infiltration intra articular and ARTHRO distension plus intensive mobilisation in people with Shoulder 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 4 inclusion and 10 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 4 Jan 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain and disability using SPADI score at 2 weeks (time frame: at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724113, which also lists 1 linked publication.
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 4 Jan 2017.