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

NCT ID: NCT02988830

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2022-01-27

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic lumbar pain

Group Type: EXPERIMENTAL

Subcutaneous Electric Lumbar Stimulation

Intervention Type: DEVICE

Interventions

Subcutaneous Electric Lumbar Stimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Christine DJIAN, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Bechir Jarraya, MD, PhD

Role: STUDY_CHAIR

Hôpital Foch

Locations

Hopital Foch

Suresnes, , France

Countries

France

Other Identifiers

2016-A00991-50

Identifier Type: OTHER

Identifier Source: secondary_id

2016/39

Identifier Type: -

Identifier Source: org_study_id