The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

Summary

Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used for decades. It is used most commonly in patients with chronic neuropathic leg pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to 60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies with sub perception paraesthesias has recently challenged the conventional form of neurostimulation.The high frequency stimulation appears to show better pain relief for both back and limb pain in comparison to low frequency SCS, and may also to be effective in some subjects who did not respond to low frequency SCS.

Conditions

• Failed Back Surgery Syndrome
• Neuropathic Pain

Interventions

DEVICE

Spinal Cord Stimulation

Crossover design whereby subjects will undergo Spinal Cord Stimulation in two arms: low frequency stimulation and high frequency stimulation

DEVICE

Group 1

9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias

DEVICE

Group 2

9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias

Sponsors & Collaborators

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Alrijne Hospital

  collaborator OTHER

• Noordwest Ziekenhuisgroep

  collaborator OTHER

• Jennifer Breel

  lead OTHER

Principal Investigators

• Markus W Hollmann, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Frank Wille, MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Jennifer S Breel, MPA,MSc. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-13

Primary Completion

2017-11-17

Completion

2018-11-30

Countries

• Netherlands

Study Locations