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Prophylactic Pregabalin Treatment Following Spinal Cord Injury

The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06066918
Enrollment
50
Registered
2023-10-04
Start date
2021-07-13
Completion date
2026-02-05
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries, Spinal Cord Diseases

Brief summary

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

Pregabalin 75 mg twice a day

Sponsors

Loewenstein Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Central pain1 yeardevelopment of central pain by interview (yes /no )
McGill Pain Questionnaire3 monthsRange 0 -78. higher scores mean worse outcome.

Countries

Israel

Contacts

Primary ContactAmiram Catz, Prof.
amiramc@clalit.org.il972-9-770-9934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026