Failed Back Surgery Syndrome
Conditions
Keywords
Spinal cord neurostimulation, chronic pain
Brief summary
The purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with Fail Back Surgery Syndrome, after chronic stimulation, in comparison with preoperative condition.
Detailed description
After the informed consent signature, a first assessment will be carried out, including: quantified analysis of walking (AQM), felt effort questionnaire, pain questionnaires, functional abilities, limitations, goals and quality of life. The implantation of the spinal cord stimulation system will be performed in two stages: the first stage, the electrode alone will be implanted and connected to an external test stimulator, allowing a one-week stimulation test. If the test is positive (EVA pain improvement \> or = 50%), the second step will be to connect this electrode to a Spectra WaveWriter™ internal stimulator. This stimulator delivers three different stimulation modalities: tonic, microburst and high frequency. The activated initial stimulation mode will be the tonic one. After 3 months of "tonic" stimulation, the patient will be treated successively and in random way by 3 other different stimulation modalities during a week: microburst, high frequency, stopped stimulation (Off). The AQM and the different questionnaires will be done again, which will determine which stimulation modality is most beneficial to the patient.
Interventions
OTHERwalking quantified analysis
Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 year old and \< or = 70 year old * Patients with chronic neuropathic lumbo-sciatalgia (DN4 score \> or = 4/10) as part of a moderate to severe spinal surgery failure syndrome (EVA \>50/100), in who a collegial and multidisciplinary indication of medullary stimulation treatment was chosen. * Patients awith Social Security
Exclusion criteria
* Vulnerable persons * Patients who are invalid and unable to perform a quantified walk analysis * Contraindication to surgery or anesthesia * Patient not able to complete questionnaires * Woman of childbearing age without effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To explore the changes in objective walking parameters induced by spinal stimulation in patients with FBSS, after 6 months of chronic stimulation, in comparison with preoperative status. | At baseline, 3 and 6 months after implantation | Gait quantified analysis with Gait Deviation Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To describe the gait alteration in a population of patients with FBSS | At baseline, 3 and 6 months after implantation | Gait quantified analysis with Gait Deviation Index |
Countries
France
Contacts
CONTACTLE GOFF Ludovic, MD
Outcome results
None listed