Management of Pain Associated With Failed Back Surgery Syndrome

NCT ID: NCT05324761

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Failed Back Surgery Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregabalin

A dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm

Group Type ACTIVE_COMPARATOR

Pregabalin 75mg

Intervention Type DRUG

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.

Gabapentin

A dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm

Group Type ACTIVE_COMPARATOR

Gabapentin 300mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Previous spine surgery and subsequent chronic back pain

Exclusion Criteria

* Patients with connective tissue diseases
* Patients with psychiatric illnesses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Kindy College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Laith Thamer Al-Ameri

assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laith Al-Ameri

Role: STUDY_DIRECTOR

University of Baghdad - Al-Kindy College of Medicine

Locations

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Laith Thamer Al-Ameri

Baghdad, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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13 Al-KindyCM

Identifier Type: -

Identifier Source: org_study_id

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