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Burst SCS evaluated

Effect of burst spinal cord stimulation evaluated in patients familiar with spinal cord stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23297
Enrollment
58
Registered
2014-03-25
Start date
2014-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathic pain

Interventions

Patients will receive two different SCS stimulator settings (burst and sham) each for a two week period.

Sponsors

Medisch Spectrum Twente, Enschede
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Over 18 years, SCS for at least 3 months, Optimal tonic stimulation, SCS system type Eon, EonC, Eon mini or Prodigy (SJM, Plano, TX), Capable of participation: travelling to the hospital and filling out the questionnaires.

Exclusion criteria

Exclusion criteria: Hospitalisation or other form of serious decline of general health, Severe pain that is interfering with the pain the SCS is used for, Received burst SCS in the past, Incapable of working with rechargeable system in the future.

Design outcomes

Primary

MeasureTime frame
The main study parameters are the scores on the VAS for pain.

Secondary

MeasureTime frame
Secondary parameters are the scores on VAS for quality of life, the McGill Pain Questionnaire, the Patients' Global Impression of Change (PGIC) scale, and the estimated walking distance. These scores will be compared for the conventional tonic, burst and sham stimulation situations. In a subgroup of patients with failed back surgery syndrome we will study the differences in brain activation between the stimulation settings, measured by changes in EEG features and evoked potentials.

Contacts

Public ContactM.C. Tjepkema-Cloostermans

Medisch Spectrum Twente

m.tjepkema-cloostermans@mst.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)