Oxidative Balance in Opioid Therapy

NCT ID: NCT04227223

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2021-02-15

Brief Summary

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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

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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.

Conditions

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Pain Opioids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy

Group Type EXPERIMENTAL

biochemical measurements

Intervention Type DIAGNOSTIC_TEST

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

Control Group

Control Group - 14 patients, healthy volunteers.

Group Type ACTIVE_COMPARATOR

biochemical measurements

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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biochemical measurements

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* depression, steroids- local or systemic administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urszula Kosciuczuk

Role: PRINCIPAL_INVESTIGATOR

Medical University in Bialystok

Locations

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Urszula Kosciuczuk

Bialystok, , Poland

Site Status

Countries

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Poland

Other Identifiers

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R-I-002/307/2019

Identifier Type: -

Identifier Source: org_study_id

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