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Clinical Trials/NCT02988830
NCT02988830
Completed
N/A

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

Hopital Foch1 site in 1 country19 target enrollmentNovember 29, 2016
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ConditionsPain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Hopital Foch
Enrollment
19
Locations
1
Primary Endpoint
Average pain per day on visual analogical scale
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2016
End Date
January 27, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Average pain per day on visual analogical scale

Time Frame: 12 months

Secondary Outcomes

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

Study Sites (1)

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