Burst Crossover Trial

NCT05372822 | Recruiting

• 1 other identifier: 2018/475-b
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain with Radiation; Pain, Postoperative

Keywords

Lumbar Vertebrae; Surgery; Postoperational Complications; Spinal Cord Stimulation

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

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

  12 months

• Change in back pain

  12 months

• change in leg pain

  12 months

• Daily physical activity

  12 months

• Six-month follow-up of pain-related disability

  18 months

Study Arms (2)

Burst SCS

EXPERIMENTAL

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

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation; Device: SCS implant

Sham SCS

SHAM COMPARATOR

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

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation; Device: SCS implant

Interventions

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

Burst SCS; Sham SCS

Sham spinal cord stimulation PROCEDURE

No spinal cord stimulation is provided

Burst SCS; Sham SCS

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

Burst SCS; Sham SCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Back Pain; Pain, Postoperative

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sasha Gulati, md prof

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Geir Bråthen, md prof

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Sasha Gulati, md prof

CONTACT

+47 73592020; sasha.gulati@ntnu.no

Sven M Carlsen, md prof

CONTACT

+47 91769528; sven.carlsen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: May 1, 2021
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)