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

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

Official Title
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Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago

Conditions
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Pain

Intervention / Treatment
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* Device: Subcutaneous Electric Lumbar Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic lumbar pain<br> | Device: Subcutaneous Electric Lumbar Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain per day on visual analogical scale |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Douleur neuropathique 4 (DN4) score | DN4 is a French neuropathic pain scale | 12 months | 
| 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 | 
| Tampa scale |  | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous stimulation