Self-rehabilitation at home after lumbar surgery
Self-rehabilitation At Home After LumbaR Arthrodesis
This study is testing if doing self-rehabilitation at home right after lumbar surgery helps patients feel less pain and improve their quality of life better than waiting for traditional physiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06129682 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of self-rehabilitation at home for patients recovering from lumbar arthrodesis, compared to traditional physiotherapy starting 4 to 6 weeks post-surgery. It is a randomized-controlled trial that aims to determine if early self-rehabilitation can lead to better outcomes in terms of lumbar pain reduction and quality of life. Patients will be monitored for changes in pain levels and functional abilities at 6 weeks and 3 months after surgery. The study is designed to provide insights into the benefits of early rehabilitation in a population that often lacks access to physiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing lumbar arthrodesis for degenerative conditions who do not have motor deficiencies.
Not a fit: Patients with motor deficiencies, psychiatric or neurodegenerative conditions, or those requiring extended hospital stays may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and improve quality of life for patients undergoing lumbar surgery.
How similar studies have performed: While the concept of self-rehabilitation is gaining traction, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Île-de-France Region
- AP-HP - Hôpital Européen Georges-Pompidou Paris, France — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Marc Khalifé, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Breno MELO, PhD
- Email: gestion-locale.drc@aphp.fr
- Phone: (0)140271988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.