Oxidative Balance in Opioid Therapy

NCT04227223 | Completed

• 1 other identifier: R-I-002/307/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Opioids

Keywords

neurological condition; opioids; oxidative balance; pain

Outcome Measures

Primary Outcomes (2)

• oxidative balance

  measurements of total oxidative capacity and total antioxidative capacity

  6 months of opioids therapy

• cognitive state

  measurements of Brain-derived Neurotrophic Function

  6 months of opioids therapy

Study Arms (2)

Study Group

EXPERIMENTAL

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

Diagnostic Test: biochemical measurements

Control Group

ACTIVE COMPARATOR

Control Group - 14 patients, healthy volunteers.

Diagnostic Test: biochemical measurements

Interventions

biochemical measurements DIAGNOSTIC_TEST

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

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• depression, steroids- local or systemic administration

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Urszula Kosciuczuk

Bialystok, 15-276, Poland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Urszula Kosciuczuk

  Medical University in Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 13, 2020
• Study Start: September 25, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)