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)

Failed Back Surgery Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421273
• Other study ID #: NL75451.091.020
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Rijnstate Hospital
• Contact: Martijn Mons, Msc.
• Phone: +31433881034
• Email: m.mons[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Spinal cord stimulation using passive recharge burst stimulation
Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.
• Spinal cord stimulation using active recharge burst stimulation
Active recharge burst is characterized by negative pulses that directly compensate for charge differences.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Hospitals A-UMC	Amsterdam	Noord-Holland
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Alrijne Hospital	Leiderdorp	Zuid-Holland
Netherlands	Bravis Hospital	Roosendaal	Noord-Brabant
Netherlands	Elizabeth TweeSteden Hospital	Tilburg	Noord-Brabant
Netherlands	Diakonessen Hospital	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

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