Clinical trial NCT05421273: 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)
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
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Spinal Pain Syndrome Type 2
Failed Back Surgery Syndrome
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain catastrophizing score
timeFrame: 6 months
Secondary outcomes:
measure: Numeric pain rating scale
timeFrame: 3, 6, 12 months
measure: Patient vigilance and awareness questionnaire
timeFrame: 3, 6, 12 months
measure: Hospital anxiety and depression scale
timeFrame: 3, 6, 12 months
measure: EQ-5D questionnaire
timeFrame: 3, 6, 12 months
measure: Oswestery disability index
timeFrame: 3, 6, 12 months
measure: Patient global impression of change
timeFrame: 3, 6, 12 months
measure: PainDETECT questionnaire
timeFrame: 3, 6, 12 months
measure: Mean charge per second used
timeFrame: 3, 6, 12 months
measure: Mean charge per hour used
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Roosendaal
country: Netherlands
facility: Bravis Hospital
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elizabeth TweeSteden Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Hospitals A-UMC
state: Noord-Holland
city: Zeist
country: Netherlands
facility: Diakonessen Hospital
state: Utrecht
city: Leiderdorp
country: Netherlands
facility: Alrijne Hospital
state: Zuid-Holland
Study officials:
References:
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.