Burst Crossover Trial

Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Back Pain With Radiation
• Intervention / Treatment: Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation; Device: SCS implant

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sasha Gulati, md prof; Phone Number: +47 73592020; Email: sasha.gulati@ntnu.no
• Study Contact Backup: Name: Sven M Carlsen, md prof; Phone Number: +47 91769528; Email: sven.carlsen@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital
    • Contact: Sasha Gulati, md phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Burst SCS; Burst Spinal cord stimulation. SCS system implanted and burst stimulation given	Procedure: 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; Procedure: Sham spinal cord stimulation; No spinal cord stimulation is provided; Device: SCS implant; a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead
Sham Comparator: Sham SCS; Sham spinal cord stimulation. SCS system implanted but no stimulation given.	Procedure: 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; Procedure: Sham spinal cord stimulation; No spinal cord stimulation is provided; Device: SCS implant; a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in disease-specific functional outcome from baseline	measured with version 2.0 of the Oswestry disability index (ODI) that has been translated into Norwegian and tested for psychometric properties. The ODI questionnaire quantifies disability for degenerative conditions of the lumbar spine and covers intensity of pain, ability to lift, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in generic health-related quality of life measured with the Euro-Qol-5D (5L)		12 months
Change in back pain	measured using numerical rating scales (NRS)	12 months
change in leg pain	measured using numerical rating scales (NRS)	12 months
Daily physical activity	measured by use of a body-worn accelerometer (activPALs from PAL Technologies Ltd., Glasgow, United Kingdom) attached by a waterproof tape to the midpoint of the patients' anterior right thigh	12 months
Health Care Provider's Costs	Cost-effectiveness (cost per gained quality-adjusted life year)	12 months

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Sasha Gulati, md prof, St. Olavs Hospital; Study Director: Geir Bråthen, md prof, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): August 15, 2025
• Study Completion (Anticipated): August 15, 2025

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Spinal Cord Stimulation; Lumbar Vertebrae; Postoperational Complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Back Pain
• Other Study ID Numbers: 2018/475-b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No