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The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

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ClinicalTrials.gov Identifier: NCT02112474
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
Diakonessenhuis, Utrecht
Rijnstate Hospital
Alrijne Hospital
Noordwest Ziekenhuisgroep
Information provided by (Responsible Party):
Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Neuropathic Pain Device: Spinal Cord Stimulation Device: Group 1 Device: Group 2 Not Applicable

Detailed Description:

Rationale:

Electrical stimulation of the dorsal columns of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used in humans for several decades. The most common indication for SCS is the treatment of refractory neuropathic leg pain, particularly when these symptoms persist after an anatomically successful operation (Failed Back Surgery Syndrome or FBSS).

Low frequency - conventional - SCS (LF-SCS) is applied in frequencies ranging from 30 to 60 Hertz (Hz) and the subject feels paraesthesias in the painful area, which is considered the ideal situation. Recently, LF-SCS has been challenged by the development of stimulation modes at higher frequencies which provide pain relief at sub-perception threshold, i.e. without paraesthesias. A recent case series reported that High Frequency Spinal Cord Stimulation (HF-SCS) appears to show better pain relief for both back and limb pain in comparison to LF-SCS, and also to be effective in some subjects who did not respond to LF-SCS.

Objective:

The primary objective of this trial is to compare pain suppression in two groups of subjects with chronic unilateral limb pain as a result of FBSS .

Study design:

A prospective, double blind (subject, physician, statistician), multi-centre, randomized, crossover trial of SCS in the treatment of subjects with refractory neuropathic leg pain after back surgery.

Study population:

Patients with chronic neuropathic refractory unilateral leg pain

Intervention:

Patients will undergo neurostimulation with low and high frequency parameters, the order in which they receive treatment will be randomized

Main study endpoint:

Pain suppression in the short and long-term (24 days and 12 months)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Both methods of stimulation are standard clinical practice performed routinely in the study centres, both groups will receive this standard care. The only difference is change of stimulation frequency and the order in which it is applied.

Possible benefit to the subject is that both forms of stimulation will be evaluated. This may lead to a better quality of life in the HF-SCS Group as result of pain relief without paraesthesias. Furthermore, non-responders to LF-SCS may benefit from HF-SCS.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation
Actual Study Start Date : November 13, 2014
Actual Primary Completion Date : January 30, 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Spinal Cord Stimulation Group 1
9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias
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

Experimental: Spinal Cord Stimulation Group 2
9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias
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 2
9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias




Primary Outcome Measures :
  1. Pain suppression by means of Spinal Cord Stimulation [ Time Frame: 24 days and 12 months ]
    Primary endpoint is measured using pain scores (VAS) via a multi-day diary


Secondary Outcome Measures :
  1. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Energy use of the battery at different frequencies

  2. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Percentage of subjects with 50% reduction in pain according to the Dutch Neuromodulation Society criteria

  3. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Use of rescue medication in the first month

  4. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Number of amplitude adjustments in trial period

  5. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Discomfort due to stimulation

  6. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Improvement in disability

  7. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Subject satisfaction

  8. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Improvement in employment status

  9. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Improvement in sleep pattern

  10. Quality of Life and pain suppression (long term) [ Time Frame: 12 months ]
    Monitoring of long term adverse reaction to both stimulation types



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112474


Locations
Netherlands
Rijnstate Hospital
Velp, Gelderland, Netherlands, 883 AZ
Medisch Centrum Alkmaar
Alkmaar, North Holland, Netherlands, 1815 JD
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Alrijne Hospital
Leiderdorp, South Holland, Netherlands, 2353 GA
Diakonessenhuis
Zeist, Utrecht, Netherlands, 3700 BA
Sponsors and Collaborators
Jennifer Breel
Diakonessenhuis, Utrecht
Rijnstate Hospital
Alrijne Hospital
Noordwest Ziekenhuisgroep
Investigators
Study Chair: Markus W Hollmann, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Frank Wille, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Director: Jennifer S Breel, MPA Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party: Jennifer Breel, Study Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02112474     History of Changes
Other Study ID Numbers: MDT-HF-2013
NL43067.018.13 ( Other Identifier: CCMO )
2013_281 ( Other Identifier: METC Academic_Medical _Center )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Failed Back Surgery Syndrome
Neuropathic pain
Leg Pain
Chronic Pain
Spinal Cord Stimulation
Neurostimulation

Additional relevant MeSH terms:
Neuralgia
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Back Pain
Postoperative Complications
Pathologic Processes