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NCT04227223 Clinical Trial

Oxidative Balance in Opioid Therapy

Pain Clinical Trial

Official title:
Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04227223
Other study ID # R-I-002/307/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2019
Est. completion date February 15, 2021

Study information
Verified date February 2021
Source Medical University of Bialystok
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 15, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - minimally, 6 months opioid therapy in chronic Low- Back Pain Exclusion Criteria: - depression, steroids- local or systemic administration

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• biochemical measurements
TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)

Locations
Country Name City State
Poland Urszula Kosciuczuk Bialystok

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

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