Oxidative Balance in Opioid Therapy

The oxidative - antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative - antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Opioids Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urszula Kosciuczuk

Bialystok, 15-276, Poland

About this study

The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

minimally, 6 months opioid therapy in chronic Low- Back Pain

Exclusion criteria

depression, steroids- local or systemic administration

Treatment and study plan

biochemical measurements

Diagnostic Test

TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)

Primary outcomes

oxidative balance

Time frame: 6 months of opioids therapy

measurements of total oxidative capacity and total antioxidative capacity
cognitive state

Time frame: 6 months of opioids therapy

measurements of Brain-derived Neurotrophic Function

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jan 13, 2020
Registry last updated: Feb 18, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed