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Clinical Trials in France / NCT06129682
Recruiting Not applicable

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

NCT06129682 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2023-12-18
Last updated
2025-03-19

Condition(s) studied

Spondylolisthesis, Lumbar Region

Investigational drug(s) / intervention(s)

Self rehabilitation at home

Self rehabilitation at home: 6 week program of exercise at home of gradual intensity and duration

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change of lumbar pain — At 6 weeks and 3 months after surgery
    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.

Trial sites (1)

FacilityCityRegionStatus
AP-HP - Hôpital Européen Georges-Pompidou Paris, France Paris Île-de-France Region Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06129682 on ClinicalTrials.gov ↗ ← All trials in France