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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04470206
Acronym
NPSI
Enrollment
100
Registered
2020-07-14
Start date
2020-10-19
Completion date
2023-12-19
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Keywords

Neuropathic pain, NPSI, Spinal Cord Stimulation

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.

Interventions

None listed

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgeryNeuropathic pain score obtained by the NPSI questionnaire

Secondary

MeasureTime frameDescription
Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)Day 0 and 12 months after surgeryAnxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire
Efficacy of spinal cord stimulation on quality of life.Day 0 and 12 months after surgeryQuality of life score assessed by EQ-5D questionnaire

Countries

France

Contacts

Primary ContactNaoufel Ouerchefani, MD
n.ouerchefani@hopital-foch.com01 46 25 35 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026