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Burst Spinal Cord Stimulation for Neuropathic Pain.

NCT03733886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-30

No results posted yet for this study

Summary

This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.

Conditions

  • Peripheral Neuropathic Pain
  • Radiculopathy
  • Lower Back Pain

Interventions

DEVICE

Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)

Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Bård Lundeland, PhD · Department of Pain Management and Research, Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Norway
  • Sweden

Study Locations

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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 NCT03733886 on ClinicalTrials.gov