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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)

Primary Purpose

Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Spinal cord stimulation using passive recharge burst stimulation

Spinal cord stimulation using active recharge burst stimulation

About this trial

This is an interventional treatment trial for Persistent Spinal Pain Syndrome Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rijnstate HospitalRecruiting
Bravis HospitalRecruiting
Elizabeth TweeSteden HospitalRecruiting
Amsterdam University Medical Hospitals A-UMCRecruiting
Diakonessen HospitalRecruiting
Alrijne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Active recharge burst stimulation

Passive recharge burst stimulation

Arm Description

Outcomes

Primary Outcome Measures

Pain catastrophizing score

Secondary Outcome Measures

Numeric pain rating scale

Patient vigilance and awareness questionnaire

Hospital anxiety and depression scale

EQ-5D questionnaire

Quality of life questionnaire

Oswestery disability index

Patient global impression of change

PainDETECT questionnaire

Characterisation of neuropathic pain components

Mean charge per second used

Measures the amount of electrical charge used

Mean charge per hour used

Measures the amount of electrical charge used

Full Information

NCT ID

NCT05421273

First Posted

June 8, 2022

Last Updated

August 3, 2023

Sponsor

Rijnstate Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05421273

Brief Title

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)

Acronym

BURST-RAP

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 16, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active recharge burst stimulation

Arm Type

Experimental

Arm Title

Passive recharge burst stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Spinal cord stimulation using passive recharge burst stimulation

Intervention Description

Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.

Intervention Type

Device

Intervention Name(s)

Spinal cord stimulation using active recharge burst stimulation

Intervention Description

Active recharge burst is characterized by negative pulses that directly compensate for charge differences.

Primary Outcome Measure Information:

Title

Pain catastrophizing score

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Numeric pain rating scale

Time Frame

3, 6, 12 months

Title

Patient vigilance and awareness questionnaire

Time Frame

3, 6, 12 months

Title

Hospital anxiety and depression scale

Time Frame

3, 6, 12 months

Title

EQ-5D questionnaire

Description

Quality of life questionnaire

Time Frame

3, 6, 12 months

Title

Oswestery disability index

Time Frame

3, 6, 12 months

Title

Patient global impression of change

Time Frame

3, 6, 12 months

Title

PainDETECT questionnaire

Description

Characterisation of neuropathic pain components

Time Frame

3, 6, 12 months

Title

Mean charge per second used

Description

Measures the amount of electrical charge used

Time Frame

3, 6, 12 months

Title

Mean charge per hour used

Description

Measures the amount of electrical charge used

Time Frame

3, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martijn Mons, Msc.

Phone

+31433881034

m.mons@maastrichtuniversity.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Jan-Willem Kallewaard, PhD

jkallewaard@rijnstate.nl

Facility Information:

Facility Name

Rijnstate Hospital

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6815 AD

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan-Willem Kallewaard, PhD

jkallewaard@rijnstate.nl

First Name & Middle Initial & Last Name & Degree

Jan-Willem Kallewaard, PhD

Facility Name

Bravis Hospital

City

Roosendaal

State/Province

Noord-Brabant

ZIP/Postal Code

4708 AE

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars Elzinga, MD

l.elzinga@bravis.nl

First Name & Middle Initial & Last Name & Degree

Lars Elzinga, MD

Facility Name

Elizabeth TweeSteden Hospital

City

Tilburg

State/Province

Noord-Brabant

ZIP/Postal Code

5042 AD

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica De Vries, MD

j.devries@etz.nl

First Name & Middle Initial & Last Name & Degree

Jessica De Vries, MD

Facility Name

Amsterdam University Medical Hospitals A-UMC

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan-Willem Kallewaard, MD

jkallewaard@rijnstate.nl

First Name & Middle Initial & Last Name & Degree

Markus Hollmann, PhD

First Name & Middle Initial & Last Name & Degree

Jan-Willem Kallewaard, PhD

Facility Name

Diakonessen Hospital

City

Zeist

State/Province

Utrecht

ZIP/Postal Code

3707 HL

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xander Zuidema, MD

xzuidema@diakhuis.nl

First Name & Middle Initial & Last Name & Degree

Xander Zuidema, MD

Facility Name

Alrijne Hospital

City

Leiderdorp

State/Province

Zuid-Holland

ZIP/Postal Code

2353 GA

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katja Burger, MD

kburger@alrijne.nl

First Name & Middle Initial & Last Name & Degree

Katja Burger, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36064598

Citation

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.

Results Reference

derived

Learn more about this trial

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)

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