Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

NCT03748290 | Unknown Phase 4 FDA Drug

• 1 other identifier: 4686-17-SMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Central Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

EXPERIMENTAL

Drug: Pregabalin

People with a SCI who will receive Placebo for 12 weeks

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Pregabalin DRUG

Pregabalin 75 mg for 12 weeks

Also known as: Lyrica

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

Placebo Oral Tablet DRUG

Placebo Oral Tablet

People with a SCI who will receive Placebo for 12 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Sheba Medical Center rehabilitaion facility

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gabi Zeilig, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabi Zeilig, Prof.

CONTACT

972-3-5303725; gabi.zeilig@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurological Rehabilitation Department

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 20, 2018
• Study Start: August 23, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

IL (1)