The Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain

NCT05373654 | Completed

• 2 other identifiers: STIMREC2022-A00683-40
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 1 year

• Evaluation of dissatisfied patients' experience to determine the causes of their dissatisfaction.

  Interview

  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.

  Up to 1 year

• Comparison of patients' satisfaction between different stimulators models.

  Up to 1 year

• Patients' satisfaction

  During the year following qualitative analysis.

Study Arms (1)

Patients that have at least one year of follow-up since the procedure.

EXPERIMENTAL

Other: F-SUS Questionnaire; Other: Interview (only for dissatisfied patients)

Interventions

F-SUS Questionnaire OTHER

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).

Patients that have at least one year of follow-up since the procedure.

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.

Patients that have at least one year of follow-up since the procedure.

Eligibility Criteria

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

You may qualify if:

• Men or women implanted with a rechargeable spinal cord stimulator in 2019 and 2020,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique Brétéché

Nantes, 44000, France

Location

Related Publications (14)

• 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.

  PMID: 34332778 BACKGROUND

• Bouhassira 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.

  PMID: 17888574 BACKGROUND

• Cameron 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.

  PMID: 15029914 BACKGROUND

• Dones 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.

  PMID: 30042314 BACKGROUND

• Blackburn 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.

  PMID: 34343680 BACKGROUND

• Melzack 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.

  PMID: 5320816 BACKGROUND

• Meyerson 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.

  PMID: 16647596 BACKGROUND

• Echeverria-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.

  PMID: 34354373 BACKGROUND

• Lam 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.

  PMID: 21992835 BACKGROUND

• Costandi 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.

  PMID: 32543118 RESULT

• Pepper 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.

  PMID: 23207787 RESULT

• Hoelzer 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.

  PMID: 28493599 RESULT

• Falowski 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.

  PMID: 30117635 RESULT

• Van 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.

  PMID: 18427231 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Interviews as Topic; Single Person

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 13, 2022
• Study Start: January 31, 2023
• Primary Completion: April 17, 2023
• Study Completion: June 30, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

FR (1)