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)

Overview

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.

Interventions

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

Primary outcome measures

• Pain catastrophizing score [Time frame: 6 months]

Secondary outcome measures (9)

• Numeric pain rating scale [Time frame: 3, 6, 12 months]
• Patient vigilance and awareness questionnaire [Time frame: 3, 6, 12 months]
• Hospital anxiety and depression scale [Time frame: 3, 6, 12 months]
• EQ-5D questionnaire [Time frame: 3, 6, 12 months]
• Oswestery disability index [Time frame: 3, 6, 12 months]
• Patient global impression of change [Time frame: 3, 6, 12 months]
• PainDETECT questionnaire [Time frame: 3, 6, 12 months]
• Mean charge per second used [Time frame: 3, 6, 12 months]
• Mean charge per hour used [Time frame: 3, 6, 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 6 centers

• Rijnstate Hospital — Arnhem
• Bravis Hospital — Roosendaal
• Elizabeth TweeSteden Hospital — Tilburg
• Amsterdam University Medical Hospitals A-UMC — Amsterdam
• Alrijne Hospital — Leiderdorp
• Diakonessen Hospital — Zeist

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. PMID 36064598

Identifiers

NCT: NCT05421273 · NL75451.091.020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗