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Sham-Controlled RCT on 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)

TerminatedNot applicableNCT03470766
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.

Study details

Official title
Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Conditions
Interventions
  • Device: Nevro Senza System (HF10 Therapy)
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Pain And Neuromodulation Academic Research Centre (PANARC); University of Exeter; National Institute for Health Research, United Kingdom; King's College London; University of Oxford; University of Liverpool; James Cook University Hospital
Start date
2018-08-14
Primary completion
2022-10-20
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Adults over the age of 18 2. Onset of low back pain \> 12 months 3. Low back pain intensity \> 60 out of 100mm on pain visual analogue scale (VAS) 4. Presence of clear component of neuropathic pain based on a PainDETECT Questionnaire score of \>19 (we will monitor this inclusion criteria in the early stage of the trial and revise if necessary) 5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography 6. On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator 7. Legally able to provide informed consent 8. Able to comply with study-related requirements, procedures and visits Exclusion Criteria: 1. Had previous spinal surgery 2. Chronic widespread pain 3. Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.) 4. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis 5. Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by \>5 degrees segmental angular movement) e.g. any forms of spondylolisthesis 6. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 7. Bleeding diathesis such as coagulopathy or thrombocytopenia 8. Immunocompromised and at an increased risk for infection 9. Systemic infection or local infection that would contraindicate SCS placement 10. Metastatic malignant disease or active local malignant disease 11. Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal) 12. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication. 13. Evidence of an active disruptive psychological or psychiatric disorder or other…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03470766