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Management of Pain Associated With Failed Back Surgery Syndrome

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Phase 4
Locations
Iraq
Study Type
Interventional
Intervention
Pregabalin 75mg
Gabapentin 300mg
Sponsored by
Al-Kindy College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring Pregabalin, Gabapentin, neuropathic pain, spine surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Previous spine surgery and subsequent chronic back pain

Exclusion Criteria:

  • Patients with connective tissue diseases
  • Patients with psychiatric illnesses

Sites / Locations

  • Laith Thamer Al-Ameri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pregabalin

Gabapentin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy in Neuropathic pain management
Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain

Secondary Outcome Measures

Full Information

First Posted
March 20, 2022
Last Updated
April 28, 2023
Sponsor
Al-Kindy College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05324761
Brief Title
Management of Pain Associated With Failed Back Surgery Syndrome
Official Title
Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Kindy College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
Pregabalin, Gabapentin, neuropathic pain, spine surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
A dose of 75 mg of Pregabalin twice daily for one month will be prescribed to each patient enrolled this study arm
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
A dose of 300 mg of Gabapentin twice daily for one month will be prescribed to each patient enrolled this study arm
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg
Intervention Description
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
Intervention Name(s)
Gabapentin 300mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy in Neuropathic pain management
Description
Visual analogue scale pain, minimum score is 0, maximum is 10, the higher ther score the more severe pain
Time Frame
outcome will be assessed one month after the initiation of medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Previous spine surgery and subsequent chronic back pain Exclusion Criteria: Patients with connective tissue diseases Patients with psychiatric illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laith Al-Ameri
Organizational Affiliation
University of Baghdad - Al-Kindy College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Laith Thamer Al-Ameri
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Management of Pain Associated With Failed Back Surgery Syndrome

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