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Clinical Trials/NCT04470206
NCT04470206
Recruiting
Not Applicable

Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire

Hopital Foch1 site in 1 country100 target enrollmentOctober 19, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathic Pain
Sponsor
Hopital Foch
Enrollment
100
Locations
1
Primary Endpoint
Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.

A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).

Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.

Registry
clinicaltrials.gov
Start Date
October 19, 2020
End Date
December 19, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • With neuropathic pain:
  • confirmed (DN4 score\> 4/10)
  • going back to one year at least
  • refractory to well-conducted medical treatments
  • Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)
  • Having given his non-opposition

Exclusion Criteria

  • Patient with sepsis
  • Having no well-conducted prior medical treatment
  • With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe depression)
  • with somatoform disorders
  • addicted to alcohol or drugs or withdrawal syndrome
  • Deprived of liberty or under guardianship.

Outcomes

Primary Outcomes

Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.

Time Frame: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery

Neuropathic pain score obtained by the NPSI questionnaire

Secondary Outcomes

  • Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)(Day 0 and 12 months after surgery)
  • Efficacy of spinal cord stimulation on quality of life.(Day 0 and 12 months after surgery)

Study Sites (1)

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