Burst Crossover Trial

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372822
• Other study ID #: 2018/475-b
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2023
• Source: St. Olavs Hospital
• Contact: Sasha Gulati, md prof
• Phone: +47 73592020
• Email: sasha.gulati[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Back Pain With Radiation
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in generic health-related quality of life measured with the Euro-Qol-5D (5L)		12 months
Secondary	Change in back pain	measured using numerical rating scales (NRS)	12 months
Secondary	change in leg pain	measured using numerical rating scales (NRS)	12 months
Secondary	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
Secondary	Health Care Provider's Costs	Cost-effectiveness (cost per gained quality-adjusted life year)	12 months