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

April 8, 2022 updated by: Hopital Foch
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic lumbar pain
Device: Subcutaneous Electric Lumbar Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average pain per day on visual analogical scale
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Marie Christine DJIAN, MD, Hopital Foch
  • Study Chair: Bechir Jarraya, MD, PhD, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Actual)

January 27, 2022

Study Completion (Actual)

January 27, 2022

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/39
  • 2016-A00991-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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