Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Cord Injuries Central Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Pregabalin 75 mg for 12 weeks

People with a SCI who will receive Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo Oral Tablet

Interventions

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Pregabalin

Pregabalin 75 mg for 12 weeks

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No