Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03748290
Status:
UNKNOWN
Last Update Posted:
2018-11-20
First Post:
2018-11-12
Brief Title:
Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studyis 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
The purpose of this studyis 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None