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

Primary Purpose

Chronic Pain, Complex Regional Pain Syndrome, Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spinal cord stimulator
Implantation of a spinal cord stimulator
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring Spinal Cord Stimulation, Quantitative Sensory Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toledo Medical Center
  • CHU de Québec - Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stimulation Off

Stimulation On

Arm Description

Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn Off during the experiment.

Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn On during the experiment.

Outcomes

Primary Outcome Measures

Change in sensory thresholds
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2016
Last Updated
July 16, 2018
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT02837822
Brief Title
Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients
Official Title
Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Complex Regional Pain Syndrome, Failed Back Surgery Syndrome
Keywords
Spinal Cord Stimulation, Quantitative Sensory Testing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Off
Arm Type
Active Comparator
Arm Description
Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn Off during the experiment.
Arm Title
Stimulation On
Arm Type
Active Comparator
Arm Description
Patients receiving the intervention "implantation with a spinal cord stimulator". The system is turn On during the experiment.
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulator
Other Intervention Name(s)
Dorsal column stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Implantation of a spinal cord stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sensory thresholds
Description
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.
Time Frame
Baseline and at least 6 months post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Prud'Homme, MD, PhD
Organizational Affiliation
Chu de Québec - Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
CHU de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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