Clinical trial NCT03748290: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Cord Injuries
Central Pain Syndrome
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2018-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Central Pain: monitored for any complaints
timeFrame: 12 weeks
measure: Central neuropathic pain severity: McGill pain questionnaire
timeFrame: 12 weeks
measure: Pain modulation capacity - Visual analog scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center rehabilitaion facility
Study officials:
affiliation: Sheba Medical Center
name: Gabi Zeilig, Prof.
role: PRINCIPAL_INVESTIGATOR
References: