Preventing central pain after spinal cord injury with Pregabalin
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
This study is testing if giving Pregabalin to people with spinal cord injuries early on can help prevent them from developing central pain during their rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loewenstein Hospital Academic / other |
| Locations | 1 site (Raanana) |
| Trial ID | NCT06066918 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Pregabalin in preventing the development of central pain in patients who have experienced a spinal cord injury (SCI) and are undergoing rehabilitation. Patients who arrive at the rehabilitation center within three months of their injury will be divided into two groups: one receiving Pregabalin and the other receiving standard care without the medication. The study will follow these participants over a period of three months to assess the incidence of central pain development in both groups. This approach seeks to determine if early intervention with Pregabalin can mitigate pain outcomes in SCI patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have sustained a spinal cord injury within the last three months and have not yet developed central pain.
Not a fit: Patients who are pregnant, have pre-existing neuropathic pain, or are currently taking Pregabalin will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of central pain in patients recovering from spinal cord injuries.
How similar studies have performed: While the use of Pregabalin for neuropathic pain is established, this specific preventative approach following spinal cord injury is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 or creatinine clearance \<60 * Sensitivity to lactose
Where this trial is running
Raanana
- Loewenstein Rehabilitation Hospital — Raanana, Israel (Recruiting)
Study contacts
- Principal investigator: Amiram Catz, Catz — Loewenstein Rehabilitation Hospital
- Study coordinator: Amiram Catz, Prof.
- Email: amiramc@clalit.org.il
- Phone: 972-9-770-9934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.