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

Pain Clinical Trial

— IMESCUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988830
• Other study ID #: 2016/39
• Secondary ID: 2016-A00991-50
• Status: Completed
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: January 27, 2022

Study information

• Verified date: April 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain
• Pain

Intervention

Device:
• Subcutaneous Electric Lumbar Stimulation

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

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