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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.
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 WaveWriterâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neurostimulation | Other | 3 months of tonic stimutaltion + 3 weeks with random stimulation mode between microburst, High frequency, stopped stimulation (Off) then stimulation with the more efficient mode (according the patient) until 6 monthe after implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| walking quantified analysis | Other | Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Gait quantified analysis with Gait Deviation Index | At baseline, 3 and 6 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the gait alteration in a population of patients with FBSS | Gait quantified analysis with Gait Deviation Index | At baseline, 3 and 6 months after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LE GOFF Ludovic, MD | Contact | +334 92 03 55 07 | legoff.l@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Nice | Recruiting | Nice | 06200 | France |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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Prospective study on the evolution of spatial-temporal parameters of walking for each mode of medullary neurostimulation.
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |