Oxidative Balance in Opioid Therapy

Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04227223

Enrollment

Registered

2020-01-13

Start date

2019-09-25

Completion date

2021-02-15

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioids, Pain

Keywords

neurological condition, opioids, oxidative balance, pain

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTbiochemical measurements

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

The serum 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. I

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* depression, steroids- local or systemic administration

Design outcomes

Primary

Measure	Time frame	Description
oxidative balance	6 months of opioids therapy	measurements of total oxidative capacity and total antioxidative capacity
cognitive state	6 months of opioids therapy	measurements of Brain-derived Neurotrophic Function

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026