Ignite Creation Date:
2024-05-06 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03546738
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2018-05-23
Brief Title:
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery A Randomized Double-blind Sham-controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None