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NCT Number: NCT05372822

Burst 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.

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Key information

Conditions

Back Pain With Radiation Back Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Location status: Recruiting

Location contact

Sasha Gulati, md phd

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period

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.

Treatment and study plan

Burst Spinal Cord Stimulation

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

Procedure

No spinal cord stimulation is provided

SCS implant

Device

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

Primary outcomes

  1. change in disease-specific functional outcome from baseline

    Time frame: 12 months

    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.

Secondary outcomes

  1. Change in generic health-related quality of life measured with the Euro-Qol-5D (5L)

    Time frame: 12 months

  2. Change in back pain

    Time frame: 12 months

    measured using numerical rating scales (NRS)

  3. change in leg pain

    Time frame: 12 months

    measured using numerical rating scales (NRS)

  4. Daily physical activity

    Time frame: 12 months

    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

  5. Six-month follow-up of pain-related disability

    Time frame: 18 months

    Back pain-related disability, leg pain, back pain, and health-related quality of life at 6 months following completion of the final randomization period when patients are unblinded and provided with handheld spinal cord stimulation programmers allowing changes to stimulation settings and switching between burst and tonic stimulation. Measured with version 2.0 of the Oswestry disability index (ODI), leg pain NRS, back pain NRS, Euro-Qol 5D

Study contacts

Contact information is provided by the study sponsor or research team.

Sasha Gulati, md prof

CONTACT

[email protected]

+47 73592020

Sven M Carlsen, md prof

CONTACT

[email protected]

+47 91769528

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 13, 2022
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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