Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Loewenstein Hospital

Status: Enrolling

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Treatments: Drug: Pregabalin 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06066918

0012-19-LOE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Pregabalin

Experimental group

Description:

Pregabalin 75 mg X2

Treatment:

Drug: Pregabalin 75mg

No treatment

No Intervention group

Description:

no treatment