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OpenTrials
Completed

NCT Number: NCT05324761

Management of 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

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laith Thamer Al-Ameri

Baghdad, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Previous spine surgery and subsequent chronic back pain

Exclusion criteria

  • Patients with connective tissue diseases
  • Patients with psychiatric illnesses

Treatment and study plan

Pregabalin 75mg

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 300mg

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Al-Kindy College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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