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

NCT04470206 | Unknown

• 1 other identifier: 2020_0080
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; NPSI; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, Île-de-France Region, 92500, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naoufel Ouerchefani, MD

  Foch Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naoufel Ouerchefani, MD

CONTACT

01 46 25 35 33; n.ouerchefani@hopital-foch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 14, 2020
• Study Start: October 19, 2020
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

FR (1)