ArthritisNCT01789463
Physiotherapy and Capsulitis
A study testing Self rehabilitation and Self rehabilitation plus physiotherapy in people with Arthritis, run by Hopital Foch at 1 site in France.
Trial summary
Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Self rehabilitation and Self rehabilitation plus physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jun 2013
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary idiopathic phase 2 capsulitis
- Diagnosis of capsulitis confirmed by shoulder dilatation
- Patients between 18 and 70 years of age
Who cannot join
- Secondary capsulitis
- Shoulder pain of other etiology
- Cognitive disorders
- Patients less than 18 years, and more than 70 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis
Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.
- Conditions
- Arthritis
- Being tested
- Self rehabilitation, Self rehabilitation plus physiotherapy
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self rehabilitationOther
Self rehabilitation plus physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Self rehabilitation | Active comparator | Self rehabilitation Receives: Other: Self rehabilitation |
| Self rehabilitation plus physiotherapy | Experimental | Self rehabilitation plus physiotherapy Receives: Other: Self rehabilitation plus physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of the shoulder joint (Score de Constant)
Measured: 12 months post shoulder dilatation
Secondary outcomes (1)
Pain Visual Analogue Scale (at evening, rest, and at movement)
Measured: 12 months post shoulder dilatation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionJun 2013
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard BOISAUBERT, MD, Study chair, Hôpital FOCH 40, rue Worth 92150 SuresnesLouis FRANCESCHI, MD, Principal investigator, IMM - 42, boulevard Jourdan 75014 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789463
- Sponsor's protocol ID
- 2010/03
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis
- ClinicalTrials.gov ID
- NCT01789463
- Acronym / sponsor ID
- 2010/03
- Conditions
- Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Feb 2013 (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.
Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self rehabilitation | Active comparator | Other: Self rehabilitationSelf rehabilitation |
| Self rehabilitation plus physiotherapy | Experimental | Other: Self rehabilitation plus physiotherapySelf rehabilitation plus physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary idiopathic phase 2 capsulitis
- Diagnosis of capsulitis confirmed by shoulder dilatation
- Patients between 18 and 70 years of age
Key exclusion criteria (4 listed)
- Secondary capsulitis
- Shoulder pain of other etiology
- Cognitive disorders
- Patients less than 18 years, and more than 70 years of age
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 |
|---|---|---|
| Self rehabilitation | Other | Self rehabilitation |
| Self rehabilitation plus physiotherapy | Other | Self rehabilitation plus physiotherapy |
Primary outcome
Function of the shoulder joint (Score de Constant)
Time frame: 12 months post shoulder dilatation
1 secondary outcome
Pain Visual Analogue Scale (at evening, rest, and at movement)
Time frame: 12 months post shoulder dilatation
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Bernard BOISAUBERT, MD study chair
Hôpital FOCH 40, rue Worth 92150 Suresnes
Louis FRANCESCHI, MD principal investigator
IMM - 42, boulevard Jourdan 75014 Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self rehabilitation and Self rehabilitation plus physiotherapy in people with Arthritis, run by Hopital Foch 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Apr 2016. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Function of the shoulder joint (Score de Constant) (time frame: 12 months post shoulder dilatation). 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 20 Apr 2016.