Pain
Conditions
Keywords
Subcutaneous stimulation
Brief summary
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.
Interventions
DEVICESubcutaneous Electric Lumbar Stimulation
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain per day on visual analogical scale | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average pain per day on visual analogical scale | 15 days | — |
| OSWESTRY DISABILITY INDEX | 12 months | — |
| 36-Item Short Form Health Survey score (SF 36) | 12 months | — |
| DALLAS self-questionnaire | 12 months | — |
| Douleur neuropathique 4 (DN4) score | 12 months | DN4 is a French neuropathic pain scale |
| Questionnaire Hospital Anxiety and Depression scale (HAD) | 12 months | — |
| Pain Catastrophizing Scale (PCS) | 12 months | — |
| Coping strategies questionnaire (CSQ) | 12 months | — |
| Fear Avoidance Belief Questionnaire (FABQ) | 12 months | — |
| Tampa scale | 12 months | — |
Countries
France
Outcome results
None listed