Management of Pain Associated With Failed Back Surgery Syndrome

NCT05324761 | Completed Phase 4

• 1 other identifier: 13 Al-KindyCM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Failed Back Surgery Syndrome

Keywords

Pregabalin; Gabapentin; neuropathic pain; spine surgery

Outcome Measures

Primary Outcomes (1)

• Efficacy in Neuropathic pain management

  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

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

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

Gabapentin

ACTIVE COMPARATOR

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

Interventions

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.

Pregabalin

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.

Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Previous spine surgery and subsequent chronic back pain

You may not qualify if:

• Patients with connective tissue diseases
• Patients with psychiatric illnesses

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead

Study Sites (1)

Laith Thamer Al-Ameri

Baghdad, Iraq

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Neuralgia

Interventions

Pregabalin; Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Laith Al-Ameri

  University of Baghdad - Al-Kindy College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 12, 2022
• Study Start: April 25, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)