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

Recruiting

• Conditions: Neuropathic Pain

• Registration Number: NCT04470206
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-14
• Study Start: 2020-10-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-12-19
• Study Completion: 2023-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 surgery	Neuropathic pain score obtained by the NPSI questionnaire

Secondary Outcome Measures

Name	Time	Method
Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)	Day 0 and 12 months after surgery	Anxiety 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 surgery	Quality of life score assessed by EQ-5D questionnaire

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, Ile De France, France