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. 2022 Sep 5;23:749. doi: 10.1186/s13063-022-06637-7
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