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The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

CompletedNot applicableNCT02112474
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation
Interventions
Sponsor
Jennifer Breel
Collaborators
Diakonessenhuis, Utrecht; Rijnstate Hospital; Alrijne Hospital; Noordwest Ziekenhuisgroep
Organization
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date
2014-11-13
Primary completion
2017-11-17
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
5

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male/female, 18 years to 70 years * Chronic, persistent, refractory, unilateral neuropathic limb pain, as a result of spinal surgery * Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain * Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months * Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area * Subject is able and willing to provide informed consent * Subject is able and willing to comply with the protocol and follow-up schedule * Subject has been included for implantation according to standard criteria from the Dutch Neuromodulation Society Exclusion Criteria: * Back pain component of more than 20% or VAS \> 40mm on 100mm scale * Bilateral limb pain * Subjects with a previous SCS implantation. * Changes in pain medication in the 2 months preceding the trial period; * Expected inability of subjects to correctly operate the neurostimulation system * Presence of any other clinically significant or disabling chronic pain condition -eg. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc. * History of coagulation disorders, lupus erythematosus, diabetes mellitus, or morbus Bechterew * Symptoms or proof of any malignant disease * Current use of medicines affecting coagulation which cannot be temporarily stopped * Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator * Life expectancy of less than 1 year * Existing or planned pregnancy in the trial period * BMI \>20 and \<35 - a minimum and maximum BMI limit are imposed due to the technical difficulties and risk of complications in underweight or morbidly obese subjects.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02112474