Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients

July 16, 2018 updated by: Michel Prud'Homme, CHU de Quebec-Universite Laval

It's well known that Spinal cord stimulation (SCS) changes the perception of chronic pain in the area stimulated by epidural electrodes. However, we don't know the effect of this type of stimulation on the perception of external sensations (temperature, touch, pressure, and vibration) and sharp pain. Quantitative sensory testing (QST) is used to quantify somatosensory phenotype. This QST battery tests different subtypes of nerve fibres (Aβ, Aδ and C) involved in the transduction of sensory information from the periphery to the spinal cord.

The purpose of this study is to evaluate the effects of the SCS on sensory perceptions of patients with chronic pain (CRPS, FBSS). Sensorial perception tests will be carried out in accordance with a standardized procedure (Rolke et al. Pain, 2006). For non-implanted patients, an initial visit will be conducted before the operation. For all participants, two other visits will take place at least 6 months after the operation to perform the tests with and without stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal cord stimulation (SCS) is a reversible and minimally invasive neuromodulation technique employs for the treatment of chronic neuropathic pain. Even if SCS is an established technology for the management of complex regional pain syndrome (CRPS) and failed back surgery syndrome (FBSS), its impacts on the sensory perception system remain misunderstood.

The purpose of this study is to evaluate the effects of the SCS on sensory perceptions of patients with chronic pain (CRPS, FBSS). Sensorial perception tests will be carried out in accordance with a standardized procedure (Rolke et al. Pain, 2006) at the level of maximum pain area (painful leg), and at two non-painful areas (contralateral leg and ipsilateral arm). The thermode "Thermal Sensory Analyser TSA-II NeuroSensory Analyzer" and its complement "Vibratory Sensory Analyzer VSA-3000" (Medoc) will be used to assess warm, cold and vibratory detection thresholds, as well as heat and cold painful thresholds. Von Frey monofilaments (Bioseb) will be used to evaluate the mechanical detection threshold. The algometer "Force Ten ™ FDX Digital" (Wagner) will measure the pressure pain threshold. Dynamic mechanical allodynia will be assessed with a standardized brush (SENSELab Brush-05, Somedic). The Neuropen (Owen Mumford) will be used to test the temporal pain summation. Participants will be recruited through the neuromodulation clinic located in Enfant-Jésus Hospital (Québec, Canada).

For non-implanted patients, an initial visit will be conducted before the operation. For all participants, two other visits will take place at least 6 months after the operation to perform the tests with and without stimulation (the order of these visits will be randomized).

For each test, an average of the absolute differences (with-without stimulation) and its confidence interval will be calculated. The results will be considered significant with p values inferior to 0,05. All analyzes will be performed with SAS (SAS 9.3 Institute Inc, Cary, NC, USA).

The protocol was peer reviewed and approved by the Ethics Committee of Enfant-Jésus Hospital. All subjects will participate after written informed consent.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1J 1Z4
        • CHU de Québec - Université Laval
  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant with a diagnosis of CRPS or FBSS that meet International Association for the Study of Pain's criteria;
  • Pain in one leg;
  • Paresthesia area limited to the treated leg;
  • No changes in the programming patterns of the device for a minimum of 30 days before the tests;
  • Informed consent.

Exclusion Criteria:

- Wounds or infections at the painful site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Stimulation Off
Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn Off during the experiment.
Device: Spinal cord stimulator
Spinal cord stimulator is a reversible and minimally invasive neuromodulation device used for the treatment of various diseases related to chronic pain, including CRPS and FBSS. Briefly, this technology uses electrical pulses to generate action potentials in nerve cells that induce paresthesias (buzzing or tingling sensations) in the affected limb and can relieve pain.
Other Names:
  • Dorsal column stimulation
Procedure: Implantation of a spinal cord stimulator
The electrical pulses are induced by one or more electrodes surgically implanted into the epidural space. These electrodes are usually placed under the skin in the abdomen or upper buttock.
ACTIVE_COMPARATOR: Stimulation On
Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn On during the experiment.
Device: Spinal cord stimulator
Spinal cord stimulator is a reversible and minimally invasive neuromodulation device used for the treatment of various diseases related to chronic pain, including CRPS and FBSS. Briefly, this technology uses electrical pulses to generate action potentials in nerve cells that induce paresthesias (buzzing or tingling sensations) in the affected limb and can relieve pain.
Other Names:
  • Dorsal column stimulation
Procedure: Implantation of a spinal cord stimulator
The electrical pulses are induced by one or more electrodes surgically implanted into the epidural space. These electrodes are usually placed under the skin in the abdomen or upper buttock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sensory thresholds
Time Frame: Baseline and at least 6 months post-implantation
Sensorial perception tests will be carried out in accordance with a standardized procedure (Rolke et al. Pain, 2006). The thermode "Thermal Sensory Analyser TSA-II NeuroSensory Analyzer" and its complement "Vibratory Sensory Analyzer VSA-3000" (Medoc) will be used to assess warm, cold and vibratory detection thresholds, as well as heat and cold painful thresholds. Von Frey monofilaments (Bioseb) will be used to evaluate the mechanical detection threshold. The algometer "Force Ten ™ FDX Digital" (Wagner) will measure the pressure pain threshold. Dynamic mechanical allodynia will be assessed with a standardized brush (SENSELab Brush-05, Somedic). The Neuropen (Owen Mumford) will be used to test the temporal pain summation.
Baseline and at least 6 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Principal Investigator: Michel Prud'Homme, MD, PhD, CHU de Québec - Université Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (ESTIMATE)

July 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-2072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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