Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain

Central neuropathic pain (CNP) is defined as chronic pain due to injury or disease in the central nervous system. This pain is most common among people with a spinal cord injuries (SCI), with a prevalence of about 50%. The central pain usually develops within a few months of spinal cord injury - and this period is significance in terms of this research work. This pain is one of the most complex and challenging pain syndromes. One of the reasons for this stems from its adherence to most treatments. Another reason is that there is partial information about the mechanism responsible for its development. Animal studies suggest that it is possible to prevent and / or reduce its development or reduce its strength by preventive treatment (given immediately after the injury). Currently, the treatments found to prevent or reduce central pain in animals are anti Inflammation and neuronal excitability suppressors such as interleukin 10.

The purpose of this study,is to explore whether pre-treatment with pregabalin prior to the development of the central pain will prevent the incidence of pain or reduce its intensity by improving pain regulation and reducing hypersensitivity.

The goal of the pharmacotherapy is to reduce the hypersensitivity- lyrica is used to reduce chronic neuropathic pain by reducing the degree of hypersensitivity in the pain system.

the objectives of this study are to examine whether early treatment of central pain can prevent or reduce the incidence of pain by improving pain regulation and reducing hypersensitivity. That is, whether there will be a difference between those who take Lyrica-Pregabalin (a drug that reduces hypersensitivity of pain) compared to placebo.

Methods: A randomized, double-blind, placebo-controlled study in which people with a fresh SCI will receive lyrica or placebo as soon as possible from their arrival at the rehabilitation hospital for 2-3 months during which pain system characteristics will be measured and monitored for central pain development.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries; Central Pain Syndrome
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gabi Zeilig, Prof.; Phone Number: 972-3-5303725; Email: gabi.zeilig@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center rehabilitaion facility
    • Contact: Gabriel Zeilig, MD; Phone Number: 972-3-5303725; Email: Gabi.Zeilig@sheba.health.gov.il
    • Principal Investigator: Gabriel Zeilig, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People with a Spinal injury below C3 2-3 weeks after the injury
• Cognitive, mental, and verbal state (understanding and speech) that allows for voluntary cooperation in research and compliance with instructions

Exclusion Criteria:

• Pregnant women
• Other neurological diseases (such as head trauma)
• Other systemic diseases that affect the sensation (such as uncontrolled diabetes).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: People with a SCI who will receive Lyrica 75mg for 12 weeks	Drug: Pregabalin; Pregabalin 75 mg for 12 weeks; Other Names: Lyrica
PLACEBO_COMPARATOR: People with a SCI who will receive Placebo for 12 weeks	Drug: Placebo Oral Tablet; Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Pain: monitored for any complaints	Subjects will be constantly monitored for any complaints of pain and the pain will be diagnosed. Upon a diagnosis of central neuropathic pain, the first outcome is achieved	12 weeks
Central neuropathic pain severity: McGill pain questionnaire	Two major quantitative parameters are derived: (1) the number of words chosen (NWC) by the subject from a list of descriptors (total score ranges between 0-19), and (2) the pain rating index (PRI)- based on summing the rank values of these words (total score ranges between 0-65). Higher values represent worse outcome.	12 weeks
Pain modulation capacity - Visual analog scale (VAS)	0=no pain, 10=most intense pain imaginable, Higher values in the VAS represent worse outcome. This outcome will be assessed with the conditioned pain modulation and the temporal summation experimental paradigms. The Conditioned Pain Modulation (CPM) paradigm is an experimental paradigm the results of which indicate on the capacity of the pain modulation systems. The magnitude of CPM will be the outcome measure and it is calculated by subtracting a pain rating on the VAS of a noxious stimulus administered alone and in the presence of another, remote stimulus. The temporal summation of pain (TSP) paradigm is an experimental paradigm the results of which indicate on the level of excitability of the pain system. The magnitude of TSP will be the outcome measure and it is calculated by subtracting a pain rating on the VAS given at the termination of a continuous noxious stimulus from that given at the beginning of the same stimulus.	12 weeks

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Tel Aviv University
• Investigators: Principal Investigator: Gabi Zeilig, Prof., Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 4686-17-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes