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Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546738
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease Intervention/treatment Phase
Back Pain With Radiation Pain, Postoperative Procedure: Burst Spinal Cord Stimulation Procedure: Sham spinal cord stimulation Device: SCS implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : February 8, 2023
Estimated Study Completion Date : February 8, 2023

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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. Health Care Provider's Costs [ Time Frame: 12 months ]
    Cost-effectiveness (cost per gained quality-adjusted life year)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Norwegian Advisory Unit on Complex Symptom Disorders, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546738


Contacts
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Contact: Sasha Gulati, md prof +47 73592020 sasha.gulati@ntnu.no
Contact: Sven M Carlsen, md prof +47 91769528 sven.carlsen@ntnu.no

Locations
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Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Sasha Gulati, md phd         
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Sasha Gulati, md prof St. Olavs Hospital
Study Director: Geir Bråthen, md prof St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03546738    
Other Study ID Numbers: 2018/475
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Lumbar Vertebrae
Surgery
Postoperational Complications
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Back Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes