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Trial record 86 of 130 for:    Complex Regional Pain Syndrome

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

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ClinicalTrials.gov Identifier: NCT02837822
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Michel Prud'Homme, CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Complex Regional Pain Syndrome Failed Back Surgery Syndrome Device: Spinal cord stimulator Procedure: Implantation of a spinal cord stimulator Not Applicable

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients
Study Start Date : October 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT02837822


Locations
United States, Ohio
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Canada
CHU de Québec - Université Laval
Québec, Canada, G1J 1Z4
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Michel Prud'Homme, MD, PhD Chu de Québec - Université Laval

Responsible Party: Michel Prud'Homme, MD, PhD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02837822     History of Changes
Other Study ID Numbers: 2015-2072
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Michel Prud'Homme, CHU de Quebec-Universite Laval:
Spinal Cord Stimulation
Quantitative Sensory Testing

Additional relevant MeSH terms:
Syndrome
Chronic Pain
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Failed Back Surgery Syndrome
Pain
Back Pain
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Postoperative Complications