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

Primary Purpose

Back Pain With Radiation, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Burst Spinal Cord Stimulation
Sham spinal cord stimulation
SCS implant
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain With Radiation focused on measuring Lumbar Vertebrae, Surgery, Postoperational Complications, Spinal Cord Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Burst SCS

Sham SCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods
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

Change from baseline in generic health-related quality of life measured with the Euro-Qol-5D (5L) between active burst stimulation and placebo stimulation periods
Change from baseline in back pain between active burst stimulation and placebo stimulation periods
measured using numerical rating scales (NRS)
Change from baseline in leg pain between active burst stimulation and placebo stimulation periods
measured using numerical rating scales (NRS)
Change from baseline in daily physical activity between active burst stimulation and placebo stimulation periods
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

Full Information

First Posted
May 23, 2018
Last Updated
August 29, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03546738
Brief Title
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
Official Title
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain With Radiation, Pain, Postoperative
Keywords
Lumbar Vertebrae, Surgery, Postoperational Complications, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Burst SCS
Arm Type
Experimental
Arm Description
Burst Spinal cord stimulation. SCS system implanted and burst stimulation given
Arm Title
Sham SCS
Arm Type
Sham Comparator
Arm Description
Sham spinal cord stimulation. SCS system implanted but no stimulation given.
Intervention Type
Procedure
Intervention Name(s)
Burst Spinal Cord Stimulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham spinal cord stimulation
Intervention Description
No spinal cord stimulation is provided
Intervention Type
Device
Intervention Name(s)
SCS implant
Intervention Description
a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Boston Scientific will be implanted: Precision NoviTM implantable pulse generator and InfinionTM CX 16-contact lead or LinearTM ST 8-contact lead.
Primary Outcome Measure Information:
Title
Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods
Description
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 Outcome Measure Information:
Title
Change from baseline in generic health-related quality of life measured with the Euro-Qol-5D (5L) between active burst stimulation and placebo stimulation periods
Time Frame
12 months
Title
Change from baseline in back pain between active burst stimulation and placebo stimulation periods
Description
measured using numerical rating scales (NRS)
Time Frame
12 months
Title
Change from baseline in leg pain between active burst stimulation and placebo stimulation periods
Description
measured using numerical rating scales (NRS)
Time Frame
12 months
Title
Change from baseline in daily physical activity between active burst stimulation and placebo stimulation periods
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasha Gulati, md prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geir Bråthen, md prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
36255427
Citation
Hara S, Andresen H, Solheim O, Carlsen SM, Sundstrom T, Lonne G, Lonne VV, Taraldsen K, Tronvik EA, Oie LR, Gulati AM, Sagberg LM, Jakola AS, Solberg TK, Nygaard OP, Salvesen OO, Gulati S. Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. 2022 Oct 18;328(15):1506-1514. doi: 10.1001/jama.2022.18231.
Results Reference
derived
PubMed Identifier
34854473
Citation
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Results Reference
derived

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

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