Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • walking quantified analysis

    Other intervention

    Test to measure anthropometry, joint amplitudes, muscle strength and spasticity of the lower limbs on a treadmill.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: neurostimulationOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline, 3 and 6 months after implantation

Secondary outcomes

1

To describe the gait alteration in a population of patients with FBSS

Gait quantified analysis with Gait Deviation Index

Time frame
At baseline, 3 and 6 months after implantation

Other outcomes

Sponsors and contacts

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