Neuropathic PainNPSINCT04470206
Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)
An observational study of Neuropathic Pain, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 19 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Foch
Suresnes, Île-de-France Region, 92500
Naoufel Ouerchefani, MD, 0033 1 46 25 35 33, n.ouerchefani@hopital-foch.com
About this study
Official title: Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire
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
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Anxiety and depression score assessed by Hospital Anxiety and Depression (HAD) questionnaire
Measured: Day 0 and 12 months after surgery
Efficacy of spinal cord stimulation on quality of life.
Quality of life score assessed by EQ-5D questionnaire
Measured: Day 0 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start19 Oct 2020
- Primary completion19 Dec 2023 (estimated)
- Study completion19 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naoufel Ouerchefani, MD, Principal investigator, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470206
- Sponsor's protocol ID
- 2020_0080
- Acronym
- NPSI
- Status last verified
- Feb 2023
- First submitted
- 8 Jul 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire
- ClinicalTrials.gov ID
- NCT04470206
- Acronym / sponsor ID
- NPSI / 2020_0080
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic pain, NPSI, Spinal Cord Stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Dec 2023 (estimated)
- Study completion
- 19 Dec 2023 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- With neuropathic pain:
- Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)
- Having given his non-opposition
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
Time frame: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery
Neuropathic pain score obtained by the NPSI questionnaire
2 secondary outcomes
Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)
Time frame: Day 0 and 12 months after surgery
Efficacy of spinal cord stimulation on quality of life.
Time frame: Day 0 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoufel Ouerchefani, MD principal investigator
Foch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naoufel Ouerchefani, MD (01 46 25 35 33 ext. 0033, n.ouerchefani@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed. (time frame: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.