Neuropathic PainSTIMRECNCT05373654
The Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain
A study testing F-SUS Questionnaire and Interview (only for dissatisfied patients) in people with Neuropathic Pain, run by Elsan at 1 site in France.
Trial summary
Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system. Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain (HAS 2014) in the trunk, upper and lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- F-SUS Questionnaire and Interview (only for dissatisfied patients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Men or women implanted with a rechargeable spinal cord stimulator in 2019 and 2020,
- Implantation carried out more than one year before the date of inclusion in the study,
- Primary implantation of a rechargeable spinal cord stimulator or replacement of a non-rechargeable spinal cord stimulator with a rechargeable spinal cord stimulator,
- Dorsal or cervical spinal cord stimulation,
- Patient operated by the same surgeon,
- Patient informed of the study and consented to take part.
Who cannot join
- Pregnant or breastfeeding woman
- Patient whose cognitive abilities, as assessed by the investigator, do not allow them to complete the F-SUS questionnaire or the numerical pain scale.
- Patient covered by legal protection measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Prospective, Monocentric Study, Assessing the Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain. Quantitative and Qualitative Evaluation Protocol
Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system.
Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain (HAS 2014) in the trunk, upper and lower limbs.
Read more
Spinal cord stimulation can be done either through a standard spinal cord stimulator or with a rechargeable spinal cord stimulator.
In this study, the investigators aim at assessing the recharge procedure and their constraints for consecutive patients operated for spinal cord stimulation with a rechargeable stimulator for the treatment of chronic neuropathic pain at the site by the same surgeon between 2019 and 2020.
Read the detailed description
Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system. The estimated prevalence in the general population in France was 31.7% in the STOPNEP study (Study of Prevalence of Neuropathic Pain). In general, neuropathic pain becomes rapidly resistant to even specific medical treatment, and treatment by neurostimulation is increasingly common. Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain in the trunk, upper and lower limbs.
The technique involves percutaneous or surgical placement of one or several electrodes in the epidural space to stimulate the dorsal columns of the spinal cord. The electrode is linked to a pacemaker-type stimulator which is usually placed in the subcutaneous abdominal area. Stimulation of the dorsal columns of the spinal cord is supposed to interrupt the transmission of pain messages to the areas of the brain involved in pain regulation.
The average estimated lifespan of batteries of standard stimulators is 3.7 years. This is highly dependent on the way the stimulator is used. A battery may last between 1 and 2 years in patients who use the stimulator continuously at high intensities and frequencies (above 5 volts and 60 Hz). In these cases, the stimulators must be frequently, and surgically replaced. Besides the inconvenience of repeated surgeries, the risk of infection increases with each procedure. This risk has been confirmed in patients with deep brain stimulation while the results are similar, but less clear, with spinal cord stimulation.
To prevent these problems, rechargeable stimulators have been developed and provide real medical progress for the reasons mentioned above. Rechargeable stimulators have been used in routine clinical practice since 2010. Certain rechargeable stimulators have a lifespan of 9 years, while others have a theoretically unlimited lifespan.
Thus, after more than 10 years of use of rechargeable spinal cord stimulators, the choice between a standard and rechargeable stimulator must be evaluated. The cost benefit is clear with rechargeable stimulators. However, the choice of device must also consider facility of use during daily life. The use of the rechargeable device is more complicated, mainly due to the fact that the stimulator must be recharged on a regular basis. To recharge the batteries, the patient places an antenna on the skin where the stimulator is located.
The recharge (the patient is advised to fully recharge the battery when it is at 50% capacity) can take 2 hours. When a "normal" intensity of stimulation is used (< 5 volts), the patient must charge the battery once a week, which is compatible with basically normal day to day activities. Management becomes more complicated, and even impossible in the intermediate and long term if a recharge takes longer and must be repeated more frequently, which occurs in about 25% of patients. In addition, with the most common rechargeable stimulators, the stimulator must remain constantly charged, because if it is completely empty it usually becomes impossible to recharge, requiring an intervention to replace the stimulator.
This study, observational, will consider patients for whom a rechargeable implantable spinal cord stimulator was placed as part of standard of care, at least one year ago.
The main goal is to determine the proportion of patients who are dissatisfied with the recharge procedure after at least one year of use, and to evaluate their experience to determine the causes of their dissatisfaction.
- Conditions
- Neuropathic Pain
- Being tested
- F-SUS Questionnaire, Interview (only for dissatisfied patients)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-SUS QuestionnaireOther
This F-SUS questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree " (Celenza A 2011, Croasmun JT 2011). The F-SUS is a short questionnaire with 10 questions (Brooke J 2013). In its original version half of the questions express strong agreement and the other half disagreement. Thus, all the even-numbered items (2, 4, 6, 8, 10) allow the participant to express a very negative opinion (disagreement). On the other hand, the odd-numbered items allow the participant to express a very positive opinion (strong agreement).
Interview (only for dissatisfied patients)Other
Patients that are dissatisfied with the recharge procedure (Score F-SUS < 70/100) will be invited to a so-called complementary information interview (an interview after the questionnaire has been completed).
The corpus (the study group that will be interviewed) will naturally be diverse men/women, patients who were improved or not by stimulation, implanted with a rechargeable stimulator directly/replacing a stimulator, different brands of stimulator… The patient must agree to the interview and the way it will be performed (signature of consent form). The interview may be face-to -face at the site or by remote videoconference depending on the wishes and availability of the patient. There is no payment for these interviews but travelling or videoconference expenses are reimbursed All interviews will be audio- taped for further qualitative analysis.
| Study group | Role | What they receive |
|---|---|---|
| Patients that have at least one year of follow-up since the procedure. | Experimental | Not described Receives: Other: F-SUS Questionnaire; Other: Interview (only for dissatisfied patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients dissatisfied with the recharge procedure after at least one year of use.
F-SUS Questionnaire. This questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree ". The F-SUS is a short questionnaire with 10 questions. The total maximum score is 100. The total score will be used for the different analyses because the F-SUS is considered to be a unidimensional score. Satisfaction will be considered to be good with a score of 70 and excellent with 90. Satisfaction is correct between 50 and 70 (indicating that the system needs to be improved). At a score below 50 the system is unusable.
Measured: Up to 1 year
Evaluation of dissatisfied patients' experience to determine the causes of their dissatisfaction.
Interview
Measured: Up to 1 year
Secondary outcomes (3)
Comparison of numerical pain scale before spinal cord stimulator surgery and at least one year after the surgery.
The analgesic result of the spinal cord stimulation will be evaluated with a numerical pain scale ranging from 0 ("No pain") to 10 ("Maximum imaginable pain"). The value that will be compared to the preoperative numerical pain scale will be the mean of 3 measurements obtained on the day (morning, noon, night) before the questionnaire is filled out.
Measured: Up to 1 year
Comparison of patients' satisfaction between different stimulators models.
The brand of rechargeable stimulator will be collected for the study. The satisfaction level will be established with the F-SUS questionnaire. This questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree ". The F-SUS is a short questionnaire with 10 questions. The total maximum score is 100. The total score will be used for the different analyses because the F-SUS is considered to be a unidimensional score. Satisfaction will be considered to be good with a score of 70 and excellent with 90. Satisfaction is correct between 50 and 70 (indicating that the system needs to be improved). At a score below 50 the system is unusable.
Measured: Up to 1 year
Patients' satisfaction
Satisfaction questionnaire
Measured: During the year following qualitative analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start31 Jan 2023
- Primary completion17 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373654
- Sponsor's protocol ID
- STIMREC
- Other IDs
- 2022-A00683-40
- Acronym
- STIMREC
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moisset X, Bouhassira D, Attal N. French guidelines for neuropathic pain: An update and commentary. Rev Neurol (Paris). 2021 Sep;177(7):834-837. doi: 10.1016/j.neurol.2021.07.004. Epub 2021 Jul 28.
PubMed 34332778Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.
PubMed 17888574Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254.
PubMed 15029914Dones I, Levi V. Spinal Cord Stimulation for Neuropathic Pain: Current Trends and Future Applications. Brain Sci. 2018 Jul 24;8(8):138. doi: 10.3390/brainsci8080138.
PubMed 30042314Blackburn AZ, Chang HH, DiSilvestro K, Veeramani A, McDonald C, Zhang AS, Daniels A. Spinal Cord Stimulation via Percutaneous and Open Implantation: Systematic Review and Meta-Analysis Examining Complication Rates. World Neurosurg. 2021 Oct;154:132-143.e1. doi: 10.1016/j.wneu.2021.07.077. Epub 2021 Jul 31.
PubMed 34343680Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
PubMed 5320816Meyerson BA, Linderoth B. Mode of action of spinal cord stimulation in neuropathic pain. J Pain Symptom Manage. 2006 Apr;31(4 Suppl):S6-12. doi: 10.1016/j.jpainsymman.2005.12.009.
PubMed 16647596Echeverria-Villalobos M, Mitchell J, Fiorda-Diaz J, Weaver T. Effects of Dorsal Column Spinal Cord Stimulation on Neuroinflammation: Revisiting Molecular Mechanisms and Clinical Outcomes on Chronic Lumbar/Leg Pain and Failed Back Surgery Syndrome. J Pain Res. 2021 Jul 30;14:2337-2345. doi: 10.2147/JPR.S309872. eCollection 2021.
PubMed 34354373Lam CK, Rosenow JM. Patient perspectives on the efficacy and ergonomics of rechargeable spinal cord stimulators. Neuromodulation. 2010 Jul;13(3):218-23. doi: 10.1111/j.1525-1403.2009.00269.x. Epub 2010 Feb 24.
PubMed 21992835Costandi S, Mekhail N, Azer G, Mehanny DS, Hanna D, Salma Y, Bolash R, Saweris Y. Longevity and Utilization Cost of Rechargeable and Non-Rechargeable Spinal Cord Stimulation Implants: A Comparative Study. Pain Pract. 2020 Nov;20(8):937-945. doi: 10.1111/papr.12926. Epub 2020 Jul 27.
PubMed 32543118Pepper J, Zrinzo L, Mirza B, Foltynie T, Limousin P, Hariz M. The risk of hardware infection in deep brain stimulation surgery is greater at impulse generator replacement than at the primary procedure. Stereotact Funct Neurosurg. 2013;91(1):56-65. doi: 10.1159/000343202. Epub 2012 Nov 29.
PubMed 23207787Hoelzer BC, Bendel MA, Deer TR, Eldrige JS, Walega DR, Wang Z, Costandi S, Azer G, Qu W, Falowski SM, Neuman SA, Moeschler SM, Wassef C, Kim C, Niazi T, Saifullah T, Yee B, Kim C, Oryhan CL, Rosenow JM, Warren DT, Lerman I, Mora R, Hayek SM, Hanes M, Simopoulos T, Sharma S, Gilligan C, Grace W, Ade T, Mekhail NA, Hunter JP, Choi D, Choi DY. Spinal Cord Stimulator Implant Infection Rates and Risk Factors: A Multicenter Retrospective Study. Neuromodulation. 2017 Aug;20(6):558-562. doi: 10.1111/ner.12609. Epub 2017 May 11.
PubMed 28493599Falowski SM, Provenzano DA, Xia Y, Doth AH. Spinal Cord Stimulation Infection Rate and Risk Factors: Results From a United States Payer Database. Neuromodulation. 2019 Feb;22(2):179-189. doi: 10.1111/ner.12843. Epub 2018 Aug 17.
PubMed 30117635Van Buyten JP, Fowo S, Spincemaille GH, Tronnier V, Beute G, Pallares JJ, Naous H, Zucco F, Krauss JK, De Andres J, Buchser E, Costantini A, Lazorthes Y. The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study. Clin J Pain. 2008 May;24(4):325-34. doi: 10.1097/AJP.0b013e31816216a9.
PubMed 18427231Durand D, Garnier PH, Durand S, Nizard J, Wyart V, Brouillet C, Lefaucheur JP, Nguyen JP. Evaluation of the usability of the spinal cord stimulator recharging procedure in the treatment of neuropathic pain. A quantitative and qualitative study. Front Pain Res (Lausanne). 2026 May 11;7:1727882. doi: 10.3389/fpain.2026.1727882. eCollection 2026.
PubMed 42199218
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Monocentric Study, Assessing the Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain. Quantitative and Qualitative Evaluation Protocol
- ClinicalTrials.gov ID
- NCT05373654
- Acronym / sponsor ID
- STIMREC / STIMREC
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 May 2022 (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.
Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system.
Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain (HAS 2014) in the trunk, upper and lower limbs.
Spinal cord stimulation can be done either through a standard spinal cord stimulator or with a rechargeable spinal cord stimulator.
In this study, the investigators aim at assessing the recharge procedure and their constraints for consecutive patients operated for spinal cord stimulation with a rechargeable stimulator for the treatment of chronic neuropathic pain at the site by the same surgeon between 2019 and 2020.
Detailed description
Neuropathic pain occurs due to one or several lesions of the central or peripheral nervous system. The estimated prevalence in the general population in France was 31.7% in the STOPNEP study (Study of Prevalence of Neuropathic Pain). In general, neuropathic pain becomes rapidly resistant to even specific medical treatment, and treatment by neurostimulation is increasingly common. Spinal cord stimulation is now recommended in France by the Haute Autorité de Santé (HAS) to relieve chronic refractory neuropathic pain in the trunk, upper and lower limbs.
The technique involves percutaneous or surgical placement of one or several electrodes in the epidural space to stimulate the dorsal columns of the spinal cord. The electrode is linked to a pacemaker-type stimulator which is usually placed in the subcutaneous abdominal area. Stimulation of the dorsal columns of the spinal cord is supposed to interrupt the transmission of pain messages to the areas of the brain involved in pain regulation.
The average estimated lifespan of batteries of standard stimulators is 3.7 years. This is highly dependent on the way the stimulator is used. A battery may last between 1 and 2 years in patients who use the stimulator continuously at high intensities and frequencies (above 5 volts and 60 Hz). In these cases, the stimulators must be frequently, and surgically replaced. Besides the inconvenience of repeated surgeries, the risk of infection increases with each procedure. This risk has been confirmed in patients with deep brain stimulation while the results are similar, but less clear, with spinal cord stimulation.
To prevent these problems, rechargeable stimulators have been developed and provide real medical progress for the reasons mentioned above. Rechargeable stimulators have been used in routine clinical practice since 2010. Certain rechargeable stimulators have a lifespan of 9 years, while others have a theoretically unlimited lifespan.
Thus, after more than 10 years of use of rechargeable spinal cord stimulators, the choice between a standard and rechargeable stimulator must be evaluated. The cost benefit is clear with rechargeable stimulators. However, the choice of device must also consider facility of use during daily life. The use of the rechargeable device is more complicated, mainly due to the fact that the stimulator must be recharged on a regular basis. To recharge the batteries, the patient places an antenna on the skin where the stimulator is located.
The recharge (the patient is advised to fully recharge the battery when it is at 50% capacity) can take 2 hours. When a "normal" intensity of stimulation is used (< 5 volts), the patient must charge the battery once a week, which is compatible with basically normal day to day activities. Management becomes more complicated, and even impossible in the intermediate and long term if a recharge takes longer and must be repeated more frequently, which occurs in about 25% of patients. In addition, with the most common rechargeable stimulators, the stimulator must remain constantly charged, because if it is completely empty it usually becomes impossible to recharge, requiring an intervention to replace the stimulator.
This study, observational, will consider patients for whom a rechargeable implantable spinal cord stimulator was placed as part of standard of care, at least one year ago.
The main goal is to determine the proportion of patients who are dissatisfied with the recharge procedure after at least one year of use, and to evaluate their experience to determine the causes of their dissatisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients that have at least one year of follow-up since the procedure. | Experimental | Other: F-SUS Questionnaire, Other: Interview (only for dissatisfied patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women implanted with a rechargeable spinal cord stimulator in 2019 and 2020,
- Implantation carried out more than one year before the date of inclusion in the study,
- Primary implantation of a rechargeable spinal cord stimulator or replacement of a non-rechargeable spinal cord stimulator with a rechargeable spinal cord stimulator,
- Dorsal or cervical spinal cord stimulation,
- Patient operated by the same surgeon,
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Patient whose cognitive abilities, as assessed by the investigator, do not allow them to complete the F-SUS questionnaire or the numerical pain scale.
- Patient covered by legal protection measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-SUS QuestionnaireThis F-SUS questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree " (Celenza A 2011, Croasmun JT 2011). The F-SUS is a short questionnaire with 10 questions (Brooke J 2013). In its original version half of the questions express strong agreement and the other half disagreement. Thus, all the even-numbered items (2, 4, 6, 8, 10) allow the participant to express a very negative opinion (disagreement). On the other hand, the odd-numbered items allow the participant to express a very positive opinion (strong agreement). | Other | Patients that have at least one year of follow-up since the procedure. |
| Interview (only for dissatisfied patients)Patients that are dissatisfied with the recharge procedure (Score F-SUS < 70/100) will be invited to a so-called complementary information interview (an interview after the questionnaire has been completed). The corpus (the study group that will be interviewed) will naturally be diverse men/women, patients who were improved or not by stimulation, implanted with a rechargeable stimulator directly/replacing a stimulator, different brands of stimulator… The patient must agree to the interview and the way it will be performed (signature of consent form). The interview may be face-to -face at the site or by remote videoconference depending on the wishes and availability of the patient. There is no payment for these interviews but travelling or videoconference expenses are reimbursed All interviews will be audio- taped for further qualitative analysis. | Other | Patients that have at least one year of follow-up since the procedure. |
Primary outcome
Proportion of patients dissatisfied with the recharge procedure after at least one year of use.
Time frame: Up to 1 year
F-SUS Questionnaire. This questionnaire uses a Likert scale including 5 possible responses ranging from " I do not agree at all" to " I completely agree ". The F-SUS is a short questionnaire with 10 questions. The total maximum score is 100. The total score will be used for the different analyses because the F-SUS is considered to be a unidimensional score. Satisfaction will be considered to be good with a score of 70 and excellent with 90. Satisfaction is correct between 50 and 70 (indicating that the system needs to be improved). At a score below 50 the system is unusable.
Evaluation of dissatisfied patients' experience to determine the causes of their dissatisfaction.
Time frame: Up to 1 year
Interview
3 secondary outcomes
Comparison of numerical pain scale before spinal cord stimulator surgery and at least one year after the surgery.
Time frame: Up to 1 year
Comparison of patients' satisfaction between different stimulators models.
Time frame: Up to 1 year
Patients' satisfaction
Time frame: During the year following qualitative analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 34332778Moisset X, Bouhassira D, Attal N. French guidelines for neuropathic pain: An update and commentary. Rev Neurol (Paris). 2021 Sep;177(7):834-837. doi: 10.1016/j.neurol.2021.07.004. Epub 2021 Jul 28.
- Background: PubMed 17888574Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.
- Background: PubMed 15029914Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254.
- Background: PubMed 30042314Dones I, Levi V. Spinal Cord Stimulation for Neuropathic Pain: Current Trends and Future Applications. Brain Sci. 2018 Jul 24;8(8):138. doi: 10.3390/brainsci8080138.
- Background: PubMed 34343680Blackburn AZ, Chang HH, DiSilvestro K, Veeramani A, McDonald C, Zhang AS, Daniels A. Spinal Cord Stimulation via Percutaneous and Open Implantation: Systematic Review and Meta-Analysis Examining Complication Rates. World Neurosurg. 2021 Oct;154:132-143.e1. doi: 10.1016/j.wneu.2021.07.077. Epub 2021 Jul 31.
- Background: PubMed 5320816Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
- Background: PubMed 16647596Meyerson BA, Linderoth B. Mode of action of spinal cord stimulation in neuropathic pain. J Pain Symptom Manage. 2006 Apr;31(4 Suppl):S6-12. doi: 10.1016/j.jpainsymman.2005.12.009.
- Background: PubMed 34354373Echeverria-Villalobos M, Mitchell J, Fiorda-Diaz J, Weaver T. Effects of Dorsal Column Spinal Cord Stimulation on Neuroinflammation: Revisiting Molecular Mechanisms and Clinical Outcomes on Chronic Lumbar/Leg Pain and Failed Back Surgery Syndrome. J Pain Res. 2021 Jul 30;14:2337-2345. doi: 10.2147/JPR.S309872. eCollection 2021.
- Background: PubMed 21992835Lam CK, Rosenow JM. Patient perspectives on the efficacy and ergonomics of rechargeable spinal cord stimulators. Neuromodulation. 2010 Jul;13(3):218-23. doi: 10.1111/j.1525-1403.2009.00269.x. Epub 2010 Feb 24.
- Results publication: PubMed 32543118Costandi S, Mekhail N, Azer G, Mehanny DS, Hanna D, Salma Y, Bolash R, Saweris Y. Longevity and Utilization Cost of Rechargeable and Non-Rechargeable Spinal Cord Stimulation Implants: A Comparative Study. Pain Pract. 2020 Nov;20(8):937-945. doi: 10.1111/papr.12926. Epub 2020 Jul 27.
- Results publication: PubMed 23207787Pepper J, Zrinzo L, Mirza B, Foltynie T, Limousin P, Hariz M. The risk of hardware infection in deep brain stimulation surgery is greater at impulse generator replacement than at the primary procedure. Stereotact Funct Neurosurg. 2013;91(1):56-65. doi: 10.1159/000343202. Epub 2012 Nov 29.
- Results publication: PubMed 28493599Hoelzer BC, Bendel MA, Deer TR, Eldrige JS, Walega DR, Wang Z, Costandi S, Azer G, Qu W, Falowski SM, Neuman SA, Moeschler SM, Wassef C, Kim C, Niazi T, Saifullah T, Yee B, Kim C, Oryhan CL, Rosenow JM, Warren DT, Lerman I, Mora R, Hayek SM, Hanes M, Simopoulos T, Sharma S, Gilligan C, Grace W, Ade T, Mekhail NA, Hunter JP, Choi D, Choi DY. Spinal Cord Stimulator Implant Infection Rates and Risk Factors: A Multicenter Retrospective Study. Neuromodulation. 2017 Aug;20(6):558-562. doi: 10.1111/ner.12609. Epub 2017 May 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-SUS Questionnaire and Interview (only for dissatisfied patients) in people with Neuropathic Pain, run by Elsan 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 29 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients dissatisfied with the recharge procedure after at least one year of use. (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373654, which also lists 15 linked publications.
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 29 Feb 2024.