Clinical trial NCT04470206: Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)
Official title: Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
NPSI
Spinal Cord Stimulation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuropathic pain following surgery or in the context of a complex regional pain syndrome and requiring spinal cord stimulation in the neurosurgery department of Foch Hospital.

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.


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.

Primary outcomes:
measure: Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
timeFrame: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery
Secondary outcomes:
measure: Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)
timeFrame: Day 0 and 12 months after surgery
measure: Efficacy of spinal cord stimulation on quality of life.
timeFrame: Day 0 and 12 months after surgery
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
state: Ile De France
Study officials:
affiliation: Foch Hospital
name: Naoufel Ouerchefani, MD
role: PRINCIPAL_INVESTIGATOR
References: