Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
Recruiting now · Not applicable
Conditions studied: Spondylolisthesis, Lumbar Region
In brief
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).
Key facts
- Study ID
- NCT06129682
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 120
- Starts
- 2023-12-18
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
- Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
- Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
- Return home possible after surgery
- After signing consent during pre-operative visit with the surgeon
You may not qualify if…
- People under 18 years-old
- Pregnant or breast-feeding women
- Psychiatric and/or neurodegenerative comorbidity
- Motor deficiency of the limbs before and/or after surgery
- Iliac extension of arthrodesis
- Any postoperative complication lengthening stay at hospital
- Medical contraindication for early rehabilitation
Where it is running
- AP-HP - Hôpital Européen Georges-Pompidou Paris, France — Paris, Île-de-France Region, France (enrolling)
Full record on ClinicalTrials.gov
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