Management of Pain Associated With Failed Back Surgery Syndrome

Sponsor

Al-Kindy College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05324761

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

27.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome	Drug: Pregabalin 75mg Drug: Gabapentin 300mg	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2022

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Efficacy in Neuropathic pain management [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