Shoulder PainERARCNCT05413213
Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder
A study testing Ambulatory rehabilitation program in people with Shoulder Pain, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Ambulatory rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2024
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years old,
- Painful shoulder for at least 1 month,
- Shoulder treated with at least one cortisone infiltration one month or more before inclusion,
- Pain ≥ 40/100 on visual analog scale,
- Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins),
- Full-thickness tear of at least one tendon of the rotator cuff attested by imaging,
- Affiliation to social security
Who cannot join
- Passive glenohumeral mobility of the shoulder limited,
- Calcifying tendinopathy on standard radiography,
- Glenohumeral arthropathy;
- Painful acromioclavicular arthropathy;
- History of shoulder fracture;
- Neurogenic pain or neurogenic motor deficit of the upper limb;
Show all 13Show fewer
- Cortisone infiltration of the shoulder in the month preceding inclusion;
- Operated shoulder;
- Systemic pathologies including inflammatory rheumatism or neoplastic pathology;
- Patient participating in another experimental research;
- Patient under legal protection (curators or guardianship)
- Patient deprived of liberty by a judicial or administrative decision
- Pregnant or breastfeeding woman
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficiency of an Ambulatory Rehabilitation Program in Patients With Shoulder Degenerative Rupture of the Rotator Cuff Tendons
The main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. , with the algo-functional state, ie pain and activity limitation, as judgment criteria, at 3 months.
Read the detailed description
Our hypothesis is that rehabilitation based on mobilization and muscular solicitation is effective in painful shoulder due to degenerative rupture of the tendons of the rotator cuff; that it reduces pain, functional limitation and the need for surgery.
Research Excluding health products:
Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation
Control group: Ambulatory rehabilitation program using of ultrasound physiotherapy
- Conditions
- Shoulder Pain
- Being tested
- Ambulatory rehabilitation program
- Keywords
- Shoulder Pain, rotator cuff tendons, Ambulatory rehabilitation
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory rehabilitation programProcedure or surgery
Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Ambulatory rehabilitation program based on mobilization and muscular solicitation Receives: Procedure: Ambulatory rehabilitation program |
| Control Group | Active comparator | Ambulatory rehabilitation program using ultrasound physiotherapy Receives: Procedure: Ambulatory rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
algo-functional scorec SPADI, measured with Visual Analog Score
Measured: At 3 month follow-up
Shoulder disability
algo-functional score SPADI, measured with Visual Analog Score
Measured: At 3 month follow-up
Secondary outcomes (1)
Shoulder active mobility
Pain subscore of the SPADI scale
Abduction strength by dynamometer, Activity limitation by the function subscore of the SPADI scale , Life quality Overall improvement perceived by the patient by the 5-point Likert scale, at 3 months, 6 months and 1 year; The total algo-functional score of the SPADI scale at 6 months and 1 year; The use of non-surgical care, Assessed by drug consumption, the number of cortisone infiltrations, The number of non-protocol rehabilitation sessions and the number of consultations outside the scope of the study; The use of surgery for degenerative rupture of the tendons of the rotator cuff by the number of surgical interventions and the Type of surgery performed in this indication during follow-up, The time off work by the number of days
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Ambulatory rehabilitation program based on mobilizations and muscular solicitations (muscle strengthening and dynamic humeral recentering), supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks, according to a standardized program . Control group: Ambulatoryrehabilitation program, consisting of ultrasound physiotherapy, supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BEAUDREUIL Johann, Pr, Study chair, Lariboisière Hospital -physical medicine and rehabilitation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413213
- Sponsor's protocol ID
- APHP200070
- Acronym
- ERARC
- Status last verified
- Apr 2022
- First submitted
- 2 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of an Ambulatory Rehabilitation Program in Patients With Shoulder Degenerative Rupture of the Rotator Cuff Tendons
- ClinicalTrials.gov ID
- NCT05413213
- Acronym / sponsor ID
- ERARC / APHP200070
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, rotator cuff tendons, Ambulatory rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 9 Jun 2022 (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 main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. , with the algo-functional state, ie pain and activity limitation, as judgment criteria, at 3 months.
Detailed description
Our hypothesis is that rehabilitation based on mobilization and muscular solicitation is effective in painful shoulder due to degenerative rupture of the tendons of the rotator cuff; that it reduces pain, functional limitation and the need for surgery.
Research Excluding health products:
Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation
Control group: Ambulatory rehabilitation program using of ultrasound physiotherapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Ambulatory rehabilitation program based on mobilizations and muscular solicitations (muscle strengthening and dynamic humeral recentering), supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks, according to a standardized program . Control group: Ambulatoryrehabilitation program, consisting of ultrasound physiotherapy, supervised by a physiotherapist, consisting of 15 individual sessions of 30 minutes each, spread over 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Ambulatory rehabilitation programAmbulatory rehabilitation program based on mobilization and muscular solicitation |
| Control Group | Active comparator | Procedure: Ambulatory rehabilitation programAmbulatory rehabilitation program using ultrasound physiotherapy |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 55 years old,
- Painful shoulder for at least 1 month,
- Shoulder treated with at least one cortisone infiltration one month or more before inclusion,
- Pain ≥ 40/100 on visual analog scale,
- Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins),
Key exclusion criteria (13 listed)
- Passive glenohumeral mobility of the shoulder limited,
- Calcifying tendinopathy on standard radiography,
- Glenohumeral arthropathy;
- Painful acromioclavicular arthropathy;
- History of shoulder fracture;
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 |
|---|---|---|
| Ambulatory rehabilitation programExperimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Shoulder Pain
Time frame: At 3 month follow-up
algo-functional scorec SPADI, measured with Visual Analog Score
Shoulder disability
Time frame: At 3 month follow-up
algo-functional score SPADI, measured with Visual Analog Score
1 secondary outcome
Shoulder active mobility
Time frame: 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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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.
BEAUDREUIL Johann, Pr study chair
Lariboisière Hospital -physical medicine and rehabilitation department
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory rehabilitation program in people with Shoulder Pain, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BEAUDREUIL Johann, Pr (01 49 95 63 08 ext. 00 33, johann.beaudreuil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: At 3 month follow-up). The study lists 2 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 9 Jun 2022.