Prophylactic Pregabalin Treatment Following Spinal Cord Injury

June 18, 2025 updated by: amiram-catz, Loewenstein Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ra'anana, Israel
        • Recruiting
        • Loewenstein Rehabilitation Hospital
        • Contact:
          • Sara Lipkin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
no treatment
Experimental: Pregabalin
Pregabalin 75 mg X2
Drug: Pregabalin 75mg
Pregabalin 75 mg twice a day
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central pain
Time Frame: 1 year
development of central pain by interview (yes /no )
1 year
McGill Pain Questionnaire
Time Frame: 3 months
Range 0 -78. higher scores mean worse outcome.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loewenstein Hospital

Investigators

  • Principal Investigator: Amiram Catz, Catz, Loewenstein Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Estimated)

February 5, 2026

Study Completion (Estimated)

February 5, 2026

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0012-19-LOE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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