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

NCT02837822 | Completed

• 1 other identifier: 2015-2072
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

Spinal Cord Stimulation; Quantitative Sensory Testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stimulation Off

ACTIVE COMPARATOR

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

Device: Spinal cord stimulator; Procedure: Implantation of a spinal cord stimulator

Stimulation On

ACTIVE COMPARATOR

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

Device: Spinal cord stimulator; Procedure: Implantation of a spinal cord stimulator

Interventions

Spinal cord stimulator DEVICE

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.

Also known as: Dorsal column stimulation

Stimulation Off; Stimulation On

Implantation of a spinal cord stimulator PROCEDURE

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.

Stimulation Off; Stimulation On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Wounds or infections at the painful site.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (2)

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

CHU de Québec - Université Laval

Québec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Complex Regional Pain Syndromes; Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Postoperative Complications; Pathologic Processes; Back Pain

Study Officials

• Michel Prud'Homme, MD, PhD

  Chu de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: July 20, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

CA (1); US (1)