Chronic Pain Clinical Trial
Official title:
Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients
NCT number | NCT02837822 |
Other study ID # | 2015-2072 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | May 2018 |
Verified date | July 2018 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | CHU de Québec - Université Laval | Québec | |
United States | University of Toledo Medical Center | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and at least 6 months post-implantation |
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