The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Phase: NA
Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Sponsor: Loewenstein Hospital

Title of protocol: The Effect of Preventive Drug Therapy on Central Pain in Patients 
with Spinal Cord Lesions 
Date: February 1, 2023 
Version: 8 
Primary investigator: Amiram Catz, MD, PhD  
IRB-number: 0012-19-LOE 
 
Objectives:  
To examine whether preventative pregabalin treatment prevents the development of 
neuropathic pain following spinal cord lesions (SCL).  
Setting: 
The Spinal Rehabilitation Department, Loewenstein Rehabilitation Medical Center, 
Raanana, Israel. 
Study design: 
Non-randomized, interventional study. 
Methods: 
Participants: 50 SCL patients. Inclusion criteria: age 18 and above; up to 3 months 
following traumatic or non-traumatic SCL; ability to give informed consent and 
cooperate. Exclusion criteria: pregnancy; neurological or other medical conditions 
that may interfere with sensation; neuropathic-like pain before recruitment (described 
as painful sensation of electric current, burning, numbness, tingling, pricking, or 
squeezing); being treated with pregabalin; blood creatinine levels >1.2; creatinine 
clearance <60; sensitivity to lactose. Informed consents will be obtained from the 
patients who conformed with the inclusion/exclusion criteria. Participants who do not 
cooperate, wish to withdraw, develop pregabalin side effects, or are transferred to 
another hospital, where treatment of the pain is changed, will be removed from the 
study.   
Treatment: Participants will be sequentially allocated to 2 groups. One group will 
include 2/3 of the patients and will receive preventive pregabalin for 12 weeks; the 
second (control) group will include the other 1/3 of the patients and will not receive 
preventative analgesics. The dose of the preventive pregabalin will be 75mg1 (once 
daily) for the first 3 days, and 75mg2, for the rest of the treatment period, followed 
by a week of gradual dosage decrease until the preventive treatment stops.   
In case of pain without neuropathic characteristics, treatment will be with paracetamol 
or NSAIDs, according to the decision of the attending physician in the Spinal 
Rehabilitation Department. If neuropathic pain, as described above, is diagnosed, the 
pregabalin dose may be increased up 600 mg/day in total. If the pain persists, the drug 
therapy may change according to the policy of the department.  

Follow-up: Demographic and clinical data will be collected from the patients' 
medical records.  
Before starting the preventive treatment, and at 6 and 12 weeks from start (and at the 
respective periods for the control group), patients will complete the following 
questionnaires: background data (only before start), 0-10 visual analogue scale for 
pain (VAS), the Pain Catastrophizing Scale, the Depression Anxiety and Stress Scale 
(DASS), the Body Vigilance Scale (BVS), and the DSM-V for post-traumatic stress 
disorder. At those times and at 3 and 9 weeks from start, patients will be interviewed 
about the development of pain. If pain is reported at the interviews or between them, 
patients will be asked to complete the McGill Pain Questionnaire to help characterize 
it.   
A physician in the Spinal Rehabilitation Department will interview patients in the 
pregabalin group about one month after the start of treatment to identify suicidal 
thoughts, which are possible side effect.  
At 6 and 12 months after being included in the study, participants will be interviewed 
about the development of pain to investigate the long-term effect of the treatment; if 
needed, they will complete the McGill Pain Questionnaire.  
In case of discharge from the Spinal Rehabilitation Department before 12 weeks from 
inclusion in the study, treatment and follow-up will continue. Adverse events will be 
reported according to the Israeli Ministry of Health regulations.