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)

NCT05421273 | Recruiting FDA Device

• 1 other identifier: NL75451.091.020
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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

Conditions

Persistent Spinal Pain Syndrome Type 2; Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain catastrophizing score

  6 months

Secondary Outcomes (9)

• 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

  3, 6, 12 months

• Oswestery disability index

  3, 6, 12 months

Study Arms (2)

Active recharge burst stimulation

EXPERIMENTAL

Device: Spinal cord stimulation using active recharge burst stimulation

Passive recharge burst stimulation

EXPERIMENTAL

Device: Spinal cord stimulation using passive recharge burst stimulation

Interventions

Spinal cord stimulation using passive recharge burst stimulation DEVICE

Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.

Passive recharge burst stimulation

Spinal cord stimulation using active recharge burst stimulation DEVICE

Active recharge burst is characterized by negative pulses that directly compensate for charge differences.

Active recharge burst stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (6)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Bravis Hospital

Roosendaal, North Brabant, 4708 AE, Netherlands

RECRUITING

Elizabeth TweeSteden Hospital

Tilburg, North Brabant, 5042 AD, Netherlands

RECRUITING

Amsterdam University Medical Hospitals A-UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Alrijne Hospital

Leiderdorp, South Holland, 2353 GA, Netherlands

NOT YET RECRUITING

Diakonessen Hospital

Zeist, Utrecht, 3707 HL, Netherlands

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Martijn Mons, Msc.

CONTACT

+31433881034; m.mons@maastrichtuniversity.nl

Jan-Willem Kallewaard, PhD

CONTACT

jkallewaard@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 16, 2022
• Study Start: February 16, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)