Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago (IMESCUT)

Hopital Foch

Status

Completed

Conditions

Pain

Treatments

Device: Subcutaneous Electric Lumbar Stimulation

Study type

Interventional

Funder types

Other

Identifiers

2016-A00991-50 (Other Identifier)

2016/39

Details and patient eligibility

About

The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients over 18 years old
Having given their non-opposition
Affiliated to a national insurance scheme or beneficiary
Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments

Exclusion criteria

patients with lumbago that can be surgically handled or which justified a medullary stimulation
having been operated for the rachis for less than 6 months;
which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
MRI planned within the next year
pregnant or breast-feeding women.