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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Subcutaneous Electric Lumbar Stimulation

• Registration Number: NCT02988830
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-29
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic lumbar pain	Subcutaneous Electric Lumbar Stimulation	-

Primary Outcome Measures

Name	Time	Method
Average pain per day on visual analogical scale	12 months

Secondary Outcome Measures

Name	Time	Method
OSWESTRY DISABILITY INDEX	12 months
Average pain per day on visual analogical scale	15 days
Pain Catastrophizing Scale (PCS)	12 months
Fear Avoidance Belief Questionnaire (FABQ)	12 months
Douleur neuropathique 4 (DN4) score	12 months	DN4 is a French neuropathic pain scale
36-Item Short Form Health Survey score (SF 36)	12 months
Tampa scale	12 months
DALLAS self-questionnaire	12 months
Questionnaire Hospital Anxiety and Depression scale (HAD)	12 months
Coping strategies questionnaire (CSQ)	12 months

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France