Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 8, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The SAHARA trial is studying whether patients who have lumbar arthrodesis surgery (a type of spinal surgery) can benefit from doing their rehabilitation exercises at home right after the operation, instead of waiting for a physiotherapist to help them 4 to 6 weeks later. The goal is to see if self-rehabilitation can reduce back pain and improve the quality of life for these patients. This is particularly important because not everyone has easy access to a physiotherapist after surgery.
To be eligible for this trial, participants need to be between 65 and 74 years old and must be experiencing back pain or related issues before or after their surgery. They should also be able to return home after the surgery and have had prior medical treatment for their pain before considering surgery. Participants in the study will have the chance to engage in self-rehabilitation at home and will be monitored to evaluate their progress. This trial is currently recruiting, and it aims to provide valuable insights into the effectiveness of home rehabilitation after spinal surgery.
Gender
ALL
Eligibility 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, Ile De France, France
Patients applied
Trial Officials
Marc Khalifé, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported