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)

Rijnstate Hospital

Status

Enrolling

Conditions

Persistent Spinal Pain Syndrome Type 2

Failed Back Surgery Syndrome

Treatments

Device: Spinal cord stimulation using passive recharge burst stimulation

Device: Spinal cord stimulation using active recharge burst stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05421273

NL75451.091.020

Details and patient eligibility

About

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

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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