Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: A Multicenter Randomized Trial (BURST-RAP Study) (BURST-RAP)

Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain

Study Overview

• Status: Recruiting
• Conditions: Failed Back Surgery Syndrome; Persistent Spinal Pain Syndrome Type 2
• Intervention / Treatment: Device: Spinal cord stimulation using active recharge burst stimulation; Device: Spinal cord stimulation using passive recharge burst stimulation

Detailed Description

This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martijn Mons, Msc.; Phone Number: +31433881034; Email: m.mons@maastrichtuniversity.nl
• Study Contact Backup: Name: Jan-Willem Kallewaard, PhD; Email: jkallewaard@rijnstate.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: Jan-Willem Kallewaard, PhD; Email: jkallewaard@rijnstate.nl
      • Principal Investigator: Jan-Willem Kallewaard, PhD
  • Noord-Brabant
    • Roosendaal, Noord-Brabant, Netherlands, 4708 AE
      • Recruiting
      • Bravis hospital
      • Contact: Lars Elzinga, MD; Email: l.elzinga@bravis.nl
      • Principal Investigator: Lars Elzinga, MD
    • Tilburg, Noord-Brabant, Netherlands, 5042 AD
      • Recruiting
      • Elizabeth TweeSteden Hospital
      • Contact: Jessica De Vries, MD; Email: j.devries@etz.nl
      • Principal Investigator: Jessica De Vries, MD
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam University Medical Hospitals A-UMC
      • Contact: Jan-Willem Kallewaard, MD; Email: jkallewaard@rijnstate.nl
      • Principal Investigator: Markus Hollmann, PhD
      • Sub-Investigator: Jan-Willem Kallewaard, PhD
  • Utrecht
    • Zeist, Utrecht, Netherlands, 3707 HL
      • Recruiting
      • Diakonessen Hospital
      • Contact: Xander Zuidema, MD; Email: xzuidema@diakhuis.nl
      • Principal Investigator: Xander Zuidema, MD
  • Zuid-Holland
    • Leiderdorp, Zuid-Holland, Netherlands, 2353 GA
      • Not yet recruiting
      • Alrijne Hospital
      • Contact: Katja Burger, MD; Email: kburger@alrijne.nl
      • Principal Investigator: Katja Burger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects between 18 and 70 years of age
• At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
• Chronic pain diagnoses as PSPS Type 2 of at least 6 months
• Neurologic exam without marked motor deficit.
• LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
• Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
• Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
• Subject is able and willing to comply with the follow-up schedule and protocol
• Subject is able to provide written informed consent

Exclusion Criteria:

• Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
• Escalating or changing pain condition within the past month as evidenced by investigator examination
• BMI ≥35
• "Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
• Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
• Subject is unable to operate the device
• Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician
• Previous Neurostimulation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active recharge burst stimulation	Device: Spinal cord stimulation using active recharge burst stimulation; Active recharge burst is characterized by negative pulses that directly compensate for charge differences.
Experimental: Passive recharge burst stimulation	Device: Spinal cord stimulation using passive recharge burst stimulation; Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain catastrophizing score	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain rating scale		3, 6, 12 months
Patient vigilance and awareness questionnaire		3, 6, 12 months
Hospital anxiety and depression scale		3, 6, 12 months
EQ-5D questionnaire	Quality of life questionnaire	3, 6, 12 months
Oswestery disability index		3, 6, 12 months
Patient global impression of change		3, 6, 12 months
PainDETECT questionnaire	Characterisation of neuropathic pain components	3, 6, 12 months
Mean charge per second used	Measures the amount of electrical charge used	3, 6, 12 months
Mean charge per hour used	Measures the amount of electrical charge used	3, 6, 12 months

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Medtronic; Abbott

Publications and helpful links

General Publications

• Mons MR, Edelbroek C, Zuidema X, Burger K, Elzinga L, de Vries J, van Kuijk S, Joosten EA, Kallewaard JW. Study protocol: Effects of active versus passive recharge burst spinal cord stimulation on pain experience in persistent spinal pain syndrome type 2: a multicentre randomized trial (BURST-RAP study). Trials. 2022 Sep 5;23(1):749. doi: 10.1186/s13063-022-06637-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Somatoform Disorders; Failed Back Surgery Syndrome
• Other Study ID Numbers: NL75451.091.020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes