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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00652-43 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.
The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).
Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.
The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).
The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.
Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | ||
| Self rehabilitation at home | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self rehabilitation at home | Other | 6 week program of exercise at home of gradual intensity and duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of lumbar pain | Improvement of Short Form 36 score (SF-36) Unit : number of points Each item is graded on a scale of 0 to 100, with 0 and 100 serving as the lowest and highest possible scores. A higher number indicates that the subject is in better overall health. | At 6 weeks and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of functional abilities | Improvement of Oswestry Disability Index (ODI) Unit : number of points The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). | At 6 weeks and 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Breno MELO, PhD | Contact | (0)140271988 | 33 | gestion-locale.drc@aphp.fr |
| Youcef Sekour | Contact | youcef.sekour@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marc Khalifé, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP - Hôpital Européen Georges-Pompidou Paris, France | Recruiting | Paris | Île-de-France Region | 75908 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| Improvement of ranges of motion - Ely test |
Improvement of Ely test Angular unit : degree ( ° ) |
| At 6 weeks and 3 months after surgery |
| Improvement of ranges of motion - Straight Leg Test | Improvement of Straight Leg Test Angular unit : degree ( ° ) | At 6 weeks and 3 months after surgery |
| Improvement of ranges of motion - Schober test | Improvement of Schober test angular unit : degree ( ° ) | At 6 weeks and 3 months after surgery |
| D009140 |
| Musculoskeletal Diseases |