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

Neuropathic Pain Clinical Trial

— NPSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470206
• Other study ID #: 2020_0080
• Status: Recruiting
• Start date: October 19, 2020
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2023
• Source: Hopital Foch
• Contact: Naoufel Ouerchefani, MD
• Phone: 01 46 25 35 33
• Email: n.ouerchefani[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.	Neuropathic pain score obtained by the NPSI questionnaire	Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery
Secondary	Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)	Anxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire	Day 0 and 12 months after surgery
Secondary	Efficacy of spinal cord stimulation on quality of life.	Quality of life score assessed by EQ-5D questionnaire	Day 0 and 12 months after surgery