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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05324761
Other study ID # 13 Al-KindyCM
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 25, 2022
Est. completion date June 30, 2022

Study information

Verified date April 2023
Source Al-Kindy College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with Previous spine surgery and subsequent chronic back pain Exclusion Criteria: - Patients with connective tissue diseases - Patients with psychiatric illnesses

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Iraq Laith Thamer Al-Ameri Baghdad

Sponsors (1)

Lead Sponsor Collaborator
Al-Kindy College of Medicine

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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