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
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Subcutaneous stimulation
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.
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
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
No
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
No
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
No
Learn more about this trial
Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
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