Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2022-05-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Back Pain With Radiation Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

During the 12 months following implantation of a spinal cord stimulation (SCS) system, the patients will undergo four three-month long periods with either burst SCS or no stimulation (sham) in a randomized order. All patients will undergo two periods of SCS and sham stimulation.

Study Groups

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Burst SCS

Burst Spinal cord stimulation. SCS system implanted and burst stimulation given

Group Type EXPERIMENTAL

Burst Spinal Cord Stimulation

Intervention Type PROCEDURE

Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode

Sham spinal cord stimulation

Intervention Type PROCEDURE

No spinal cord stimulation is provided

SCS implant

Intervention Type DEVICE

a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.

The following system from Boston Scientific will be implanted: Precision NoviTM implantable pulse generator and InfinionTM CX 16-contact lead or LinearTM ST 8-contact lead.

Sham SCS

Sham spinal cord stimulation. SCS system implanted but no stimulation given.

Group Type SHAM_COMPARATOR

Burst Spinal Cord Stimulation

Intervention Type PROCEDURE

Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode

Sham spinal cord stimulation

Intervention Type PROCEDURE

No spinal cord stimulation is provided

SCS implant

Intervention Type DEVICE

a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.

The following system from Boston Scientific will be implanted: Precision NoviTM implantable pulse generator and InfinionTM CX 16-contact lead or LinearTM ST 8-contact lead.

Interventions

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Burst Spinal Cord Stimulation

Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode

Intervention Type PROCEDURE

Sham spinal cord stimulation

No spinal cord stimulation is provided

Intervention Type PROCEDURE

SCS implant

a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.

The following system from Boston Scientific will be implanted: Precision NoviTM implantable pulse generator and InfinionTM CX 16-contact lead or LinearTM ST 8-contact lead.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
* Minimum pain intensity of 5/10 on the leg pain NRS at baseline
* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital

Exclusion Criteria

* Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
* Abnormal pain behavior and/or unresolved psychiatric illness.
* Unresolved issues of secondary gain or inappropriate medication use.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No