Prophylactic Pregabalin Treatment Following Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin 75mg.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Spinal Cord Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Overview
Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.
Detailed description
Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.
Interventions
- Drug Pregabalin 75mg
Pregabalin 75 mg twice a day
Primary outcome measures
- Central pain [Time frame: 1 year]
- McGill Pain Questionnaire [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Loewenstein Rehabilitation Hospital — Raanana
Identifiers
NCT: NCT06066918 · 0012-19-LOE