Oxidative Balance in Opioid Therapy

Study Overview
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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.

Official Title
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Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy

Conditions
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Opioids, Pain

Intervention / Treatment
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* Diagnostic Test: biochemical measurements


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy | Diagnostic Test: biochemical measurements<br>* TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)<br>|
| Active Comparator: Control Group<br>Control Group - 14 patients, healthy volunteers. | Diagnostic Test: biochemical measurements<br>* TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurological condition, opioids, oxidative balance, pain