Back to results

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

Primary Purpose

Pain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Subcutaneous Electric Lumbar Stimulation

About this trial

This is an interventional treatment trial for Pain focused on measuring Subcutaneous stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic lumbar pain

Arm Description

Outcomes

Primary Outcome Measures

Average pain per day on visual analogical scale

Secondary Outcome Measures

Douleur neuropathique 4 (DN4) score

DN4 is a French neuropathic pain scale

Average pain per day on visual analogical scale

OSWESTRY DISABILITY INDEX

36-Item Short Form Health Survey score (SF 36)

DALLAS self-questionnaire

Tampa scale

Questionnaire Hospital Anxiety and Depression scale (HAD)

Pain Catastrophizing Scale (PCS)

Coping strategies questionnaire (CSQ)

Fear Avoidance Belief Questionnaire (FABQ)

Full Information

NCT ID

NCT02988830

First Posted

November 30, 2016

Last Updated

April 8, 2022

Sponsor

Hopital Foch

1. Study Identification

Unique Protocol Identification Number

NCT02988830

Brief Title

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

Acronym

IMESCUT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

November 29, 2016 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hopital Foch

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Subcutaneous stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic lumbar pain

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Subcutaneous Electric Lumbar Stimulation

Primary Outcome Measure Information:

Title

Average pain per day on visual analogical scale

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Douleur neuropathique 4 (DN4) score

Description

DN4 is a French neuropathic pain scale

Time Frame

12 months

Title

Average pain per day on visual analogical scale

Time Frame

15 days

Title

OSWESTRY DISABILITY INDEX

Time Frame

12 months

Title

36-Item Short Form Health Survey score (SF 36)

Time Frame

12 months

Title

DALLAS self-questionnaire

Time Frame

12 months

Title

Tampa scale

Time Frame

12 months

Title

Questionnaire Hospital Anxiety and Depression scale (HAD)

Time Frame

12 months

Title

Pain Catastrophizing Scale (PCS)

Time Frame

12 months

Title

Coping strategies questionnaire (CSQ)

Time Frame

12 months

Title

Fear Avoidance Belief Questionnaire (FABQ)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Christine DJIAN, MD

Organizational Affiliation

Hôpital Foch

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bechir Jarraya, MD, PhD

Organizational Affiliation

Hôpital Foch

Official's Role

Study Chair

Facility Information:

Facility Name

Hopital Foch

City

Suresnes

ZIP/Postal Code

92150

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs