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Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

Primary Purpose

Spinal Cord Injuries, Central Pain Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Pregabalin
Placebo Oral Tablet
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sheba Medical Center rehabilitaion facilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

People with a SCI who will receive Lyrica 75mg for 12 weeks

People with a SCI who will receive Placebo for 12 weeks

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2018
Last Updated
November 18, 2018
Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT03748290
Brief Title
Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI
Official Title
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Central Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The placebo pills will be purchased from Trilog, which is licensed and licensed by the Ministry of Health to prepare random drug kits (the company has an agreement with Sheba). The drug will be used by the company that supplies the drug and placebo, so that the researchers in the study did not know which treatment was given to each patient. This information will be received at the end of the study, or if the subjects for any reason participate in the research
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
People with a SCI who will receive Lyrica 75mg for 12 weeks
Arm Type
Experimental
Arm Title
People with a SCI who will receive Placebo for 12 weeks
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Pregabalin 75 mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Central Pain: monitored for any complaints
Description
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
Time Frame
12 weeks
Title
Central neuropathic pain severity: McGill pain questionnaire
Description
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.
Time Frame
12 weeks
Title
Pain modulation capacity - Visual analog scale (VAS)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabi Zeilig, Prof.
Phone
972-3-5303725
Email
gabi.zeilig@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabi Zeilig, Prof.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center rehabilitaion facility
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Zeilig, MD
Phone
972-3-5303725
Email
Gabi.Zeilig@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Gabriel Zeilig, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

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