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 Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: Spinal cord stimulation using passive recharge burst stimulation
* Device: Spinal cord stimulation using active recharge burst stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |