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Clinical Trial

Burst Crossover Trial

NCT: NCT05372822 · ACTIVE_NOT_RECRUITING

NCT IDNCT05372822
StatusACTIVE_NOT_RECRUITING
Start Date2021-05-01
Completion2026-12-15
SponsorSt. Olavs Hospital (OTHER)
First posted
Last updated

Brief Summary

Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant. 'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation. The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation. The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.

Frequently Asked Questions

What is Burst Crossover Trial?

Burst Crossover Trial is a clinical trial registered under NCT05372822. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05372822?

The current status of NCT05372822 (Burst Crossover Trial) is: ACTIVE_NOT_RECRUITING.

When did Burst Crossover Trial start?

Burst Crossover Trial started on 2021-05-01.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.