Health TrialsbyHealthPanel

Burst Crossover Trial

ConditionsBack Pain with RadiationPain, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Burst Spinal Cord Stimulation

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Burst SCSExperimental treatment 3 interventions
Group B: Sham SCSSham comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

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

measured using numerical rating scales (NRS)

Time frame
12 months
3

change in leg pain

measured using numerical rating scales (NRS)

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator

Source ClinicalTrials.gov
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