Management of Pain Associated With Failed Back Surgery Syndrome

April 28, 2023 updated by: Laith Thamer Al-Ameri, Al-Kindy College of Medicine

Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome

Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.

our study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Laith Thamer Al-Ameri

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Previous spine surgery and subsequent chronic back pain

Exclusion Criteria:

  • Patients with connective tissue diseases
  • Patients with psychiatric illnesses

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
A dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm
Drug: Pregabalin 75mg
Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.
Active Comparator: Gabapentin
A dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm
Drug: Gabapentin 300mg
Each patient complaining of pain associated with spine surgery who is randomly enrolled this arm of the study and start the specific medication of the arm with the recommended dose and duration for a period of one month, patient will be followed regularly regarding compliance to doses and to register any side effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in Neuropathic pain management
Time Frame: outcome will be assessed one month after the initiation of medication
Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain
outcome will be assessed one month after the initiation of medication

Collaborators and Investigators

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

Sponsor

Al-Kindy College of Medicine

Investigators

  • Study Director: Laith Al-Ameri, University of Baghdad - Al-Kindy College of Medicine

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)

April 25, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 Al-KindyCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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