Clincosm LogoSign in Get a demo

Oxidative Balance in Opioid Therapy

Sponsor
Medical University of Bialystok (Other)
Overall Status
Completed
CT.gov ID
NCT04227223
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
16.7
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: biochemical measurements
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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. IThe 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)
Primary Purpose:
Diagnostic
Official Title:
Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy
Actual Study Start Date :
Sep 25, 2019
Actual Primary Completion Date :
Feb 15, 2021
Actual Study Completion Date :
Feb 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

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

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

Control Group - 14 patients, healthy volunteers.

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

Outcome Measures

Primary Outcome Measures

  1. oxidative balance [6 months of opioids therapy]

    measurements of total oxidative capacity and total antioxidative capacity

  2. cognitive state [6 months of opioids therapy]

    measurements of Brain-derived Neurotrophic Function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • minimally, 6 months opioid therapy in chronic Low- Back Pain
Exclusion Criteria:
  • depression, steroids- local or systemic administration

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urszula Kosciuczuk Bialystok Poland 15-276

Sponsors and Collaborators

  • Medical University of Bialystok

Investigators

  • Principal Investigator: Urszula Kosciuczuk, Medical University in Bialystok

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Bialystok
ClinicalTrials.gov Identifier:
NCT04227223
Other Study ID Numbers:
  • R-I-002/307/2019
First Posted:
Jan 13, 2020
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medical University of Bialystok
neurological condition
opioids
oxidative balance
pain

Study Results

No Results Posted as of Feb 18, 2021