Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
IMESCUT
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Nov 2016
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2016
CompletedFirst Submitted
Initial submission to the registry
November 30, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2022
CompletedApril 11, 2022
April 1, 2022
5.2 years
November 30, 2016
April 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average pain per day on visual analogical scale
12 months
Secondary Outcomes (10)
Douleur neuropathique 4 (DN4) score
12 months
Average pain per day on visual analogical scale
15 days
OSWESTRY DISABILITY INDEX
12 months
36-Item Short Form Health Survey score (SF 36)
12 months
DALLAS self-questionnaire
12 months
- +5 more secondary outcomes
Study Arms (1)
Chronic lumbar pain
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Foch
Suresnes, 92150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Christine DJIAN, MD
Hôpital Foch
- STUDY CHAIR
Bechir Jarraya, MD, PhD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2016
First Posted
December 9, 2016
Study Start
November 29, 2016
Primary Completion
January 27, 2022
Study Completion
January 27, 2022
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share