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

NCT03470766 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Low Back Pain
  • Neuropathic Pain
  • Refractory Pain

Interventions

DEVICE

Nevro Senza System (HF10 Therapy)

Nevro 10kHz High Frequency Spinal Cord Stimulation

Sponsors & Collaborators

  • Pain And Neuromodulation Academic Research Centre (PANARC)

    collaborator OTHER

  • University of Exeter

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • King's College London

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • James Cook University Hospital

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2022-10-20
Completion
2022-10-20
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470766 on ClinicalTrials.gov