Data category | Information |
Primary registry and trial identifying number |
Clinicaltrials.gov: NCT05421273, registered Netherlands Trial Register NL9194, registered |
Date of registration in primary registry | 23 January 2021 |
Secondary identifying numbers | n/a |
Source(s) of monetary or material support | Abbott Laboratories |
Primary sponsor | Abbott Laboratories |
Secondary sponsor(s) | N/A |
Contact for public queries | MRM m.mons@maastrichtunversity.nl, JWK jkallewaard@rijnstate.nl |
Contact for scientific queries | MRM m.mons@maastrichtunversity.nl, JWK jkallewaard@rijnstate.nl |
Public title | N/A |
Scientific 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) |
Countries of recruitment | The Netherlands |
Health condition(s) or problem(s) studied | Persistent Spinal Pain Syndrome Type 2 |
Intervention(s) | Passive recharge burst (Burst DRTM) spinal cord stimulation |
Active recharge burst spinal cord stimulation | |
Key inclusion and exclusion criteria | Ages eligible for study: ≥18 years Sexes eligible for study: both |
Inclusion criteria Subjects between 18 and 65 years of age At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20. History consistent with PSPS Type 2 of at least 6 months | |
Exclusion criteria 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 | |
Study type | Investigator initiated multicenter randomized clinical trial |
Allocation: Unblinded randomization | |
Primary purpose: Pain Experience | |
Date of first enrolment | February 2022 |
Target sample size | 94 |
Recruitment status | Recruiting |
Primary outcome(s) | Change on the PCS scale |
Key secondary outcomes | Change in low back and leg pain intenstity, PVAQ, HADS, EQ-5D, ODI, PGIC, analgesia intake and PainDETECT rates |