Status:
COMPLETED
New Markers to Assess the Efficacity of Spinal Cord Stimulation for the Treatment of Chronic Lower Limb Pain (MOTIVE)
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Conditions:
Spinal Cord Stimulation
Eligibility:
All Genders
18-75 years
Brief Summary
By combining the usual care of patients eligible for spinal cord stimulation (SME) with measurements of the HRV index (Heart Rate Variability), objective measurements of activity (number of steps, qua...
Detailed Description
The rebellious chronic neuropathic pain of the lower limbs (including the sequelae lumbosciatica) causes a major functional repercussion and an impairment of the quality of life. Spinal cord stimulati...
Eligibility Criteria
Inclusion
- Lower limb pain included in the inclusion criteria for spinal cord stimulation according to HAS recommendations: neuropathic, lumbar radicular sequelae after spinal surgery, complex regional pain syndrome (CRPS)
- Chronic pain that has been present for at least 6 months
- Rebellious pain resistant to drug and non-drug treatments well conducted;
- Functional impact defined by a score\> 20% on the Oswestry scale;
- Patient affiliated or beneficiary of a social security scheme;
- Patient who consented to participate in the study.
Exclusion
- Presence of a surgical contraindication to the implantation of material (chronic infection, long-term anticoagulant treatment that cannot be interrupted, contraindication to anesthesia);
- Addiction (according to DSM IV);
- Major depressive syndrome despite appropriate treatment and / or psychotic symptoms (according to DSM IV);
- Unbalanced psychiatric disorder;
- Intermittent pain or present for less than 6 months;
- Diffuse painful syndrome;
- Progressive disease, associated inflammatory rheumatic pathology, and any other disabling pathology limiting physical activity (advanced articular osteoarthritis);
- Absolute contraindication to MRI (e.g. pace-maker, implantable stimulator, intra-orbital metallic foreign body);
- Language barrier or cognitive disorders preventing understanding of the research protocol;
- Person benefiting from a legal protection measure;
- Pregnant or breastfeeding woman.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04785001
Start Date
July 6 2021
End Date
May 27 2025
Last Update
June 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondation Ophtalmologie Adolphe de Rothschild
Paris, paris, France, 75019