Trial record 8 of 207 for:    Paresthesia

The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
Diakonessenhuis, Utrecht
Rijnstate Hospital
Rijnland Ziekenhuis
Information provided by (Responsible Party):
Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02112474
First received: March 25, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention
Failed Back Surgery Syndrome
Neuropathic Pain
Device: Spinal Cord Stimulation
Device: Group 1
Device: Group 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Pain suppression by means of Spinal Cord Stimulation [ Time Frame: 24 days and 12 months ] [ Designated as safety issue: No ]
    Primary endpoint is measured using pain scores (VAS) via a multi-day diary


Secondary Outcome Measures:
  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Energy use of the battery at different frequencies

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of subjects with 50% reduction in pain according to the Dutch Neuromodulation Society criteria

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of rescue medication in the first month

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of amplitude adjustments in trial period

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Discomfort due to stimulation

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in disability

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject satisfaction

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in employment status

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in sleep pattern

  • Quality of Life and pain suppression (long term) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Monitoring of long term adverse reaction to both stimulation types


Estimated Enrollment: 30
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 130 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 130 Hertz and sub-perception paraesthesias

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112474

Contacts
Contact: Frank Wille, M.D. +31205669111 ext 64032 f.wille@amc.uva.nl
Contact: Jennifer S Breel, MPA +31882505037 j.s.breel@amc.uva.nl

Locations
Netherlands
Rijnstate Hospital Not yet recruiting
Velp, Gelderland, Netherlands, 883 AZ
Contact: Jan Willem Kallewaard, M.D.    +31880058888    jkallewaard@rijnstate.nl   
Sub-Investigator: Jan Willem Kallewaard, M.D         
Academic Medical Center Not yet recruiting
Amsterdam, North Holland, Netherlands, 1105 AZ
Contact: Frank Wille, M.D.    +31205669111 ext 64032    f.wille@amc.uva.nl   
Contact: Jennifer S Breel, MPA    +31882505037    j.s.breel@amc.uva.nl   
Principal Investigator: Frank Wille, M.D.         
Sub-Investigator: Jennifer S Breel, MPA         
Rijnland Hospital Not yet recruiting
Leiderdorp, South Holland, Netherlands, 2353 GA
Contact: Robert Sie, M.D.    +31715828282    r.sie@rijnland.nl   
Sub-Investigator: Robert Sie, M.D.         
Diakonessenhuis Not yet recruiting
Zeist, Utrecht, Netherlands, 3700 BA
Contact: Frank Wille, M.D.    +31205669111 ext 64032    f.wille@amc.uva.nl   
Contact: Jennifer S Breel, MPA    +31882505037    j.s.breel@amc.uva.nl   
Principal Investigator: Frank Wille, M.D.         
Sub-Investigator: Jennifer S Breel, MPA         
Sponsors and Collaborators
Jennifer Breel
Diakonessenhuis, Utrecht
Rijnstate Hospital
Rijnland Ziekenhuis
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)
  More Information

No publications provided

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, 2013_281
Study First Received: March 25, 2014
Last Updated: April 10, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by 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

ClinicalTrials.gov processed this record on August 27, 2014