The Relationship Between Chronic OA Pain and Cognition Deficits in OA Patients.

October 4, 2022 updated by: Chun-Hsien Wen, Kaohsiung Veterans General Hospital.

The goal of this observational study is to learn about the association between pain characteristics and cognitive functions in chronic knee osteoarthritis. The main questions it aims to answer are:

  1. If pain characteristics affect cognitive functions in severe knee OA patients?
  2. If concentration of neuroinflammation mediators were raised in severe knee OA patients with comparing with control group participants?

Participants will receive pain and cognition questionnaire before surgery and their blood and CSF will be collected for further analysis of neuroinflammation mediators.

Study Overview

Status

Completed

Conditions

Detailed Description

In the previous studies, which revealed that because neural systems involved in cognition and pain processing are closely linked, they may affect with each other. In addition to sensory symptoms, cognitive functioning is thought to be affected in chronic pain patients. Pain uses cognitive resources, alters neural plasticity and affects expression and activity of a variety of chemical and cellular neuromediators. There are several brain regions such as amygdala and hippocampus which are most commonly activated during pain processing.Osteoarthritis (OA) of the knee is one of the leading causes of disability among noninstitutionalized elderly adults. One population-based study revealed that osteoarthritis increases the risk of cognitive deficits diseases such as dementia. However the possible mechanism had not be elucidated. Recent study revealed that OA-induced hyperalgesia was associated with increased nerve growth factor (NGF)/tropomycin receptor kinase A (TrkA) signaling. NGF activation of extracellular signal-regulated kinase (ERK)/ mitogen-activated protein kinase (MAPK) may play a role in centralization of OA pain. Otherwise NGF has also been shown to produce a dramatic upregulation of brain-derived neurotrophic factor (BDNF) in trkA-expressing dorsal root ganglion (DRG) cells, and there is now growing evidence that BDNF may serve as a central regulator of excitability and is a neuromodulate or of central pain processing. On the other hand, in previous studies they showed that BDNF plays a critical role in synaptic plasticity, memory processes and storage of long-term memory. The BDNF/tropomycin receptor kinase B (TrkB) system in the hippocampus plays a crucial role not only in the memory acquisition, but also in the retention and / or recall of spatial memory.

Besides ongoing pain in chronic knee OA is characterized by increased brain activity in limbic-affective regions thus providing novel evidence for a strong emotional component of arthritis pain. There are feedback loops exist between pain, emotion and cognition. How is the role of BDNF in such loop? The objective of the study was the evaluation of association between pain characteristics and cognitive functions in severe knee OA patients. Besides, we will try to explore the possible mechanisms by which chronic OA like pain develops to cognitive deficits in animal models. The relationship between BDNF levels in body fluids (serum and CSF) and pain characteristics and cognitive function was also evaluated in the whole sample.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zuoying Dist
      • Kaohsiung city, Zuoying Dist, Taiwan, 813414
        • Kaohsiung Veterans General Hopital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with chronic knee osteoarthritis pain who will receive total knee replacement surgery. They have no other chronic pain except chronic knee pain. Furthermore they did not have any cerebral diseases such as stroke or brain tumor.

Description

Inclusion Criteria:

  • OA patients who were scheduled to receive elective surgery which need spinal anesthesia.
  • Age is more than 20 years old.
  • American Society of Anesthesiologists (ASA) class I-III.

Exclusion Criteria:

  • Unwilling to participate.
  • Age is lesser than 20 years old.
  • Autoimmune diseases.
  • Previous knee injury or infection history.
  • Brain region disease ex: stroke or brain tumor...etc.
  • Mild cognitive impairment, dementia or other neurodegenerative diseases.
  • Cancer.
  • With other chronic pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OA group
Knee osteoarthritis patients who were scheduled to receive elective total knee replacement surgery which need spinal anesthesia.
Control group
Control group patients were scheduled to receive elective general surgery or urological surgery with spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster universities Osteoarthritis Index (WOMAC)
Time Frame: The WOMAC questionnaire were measured on the day before their surgery.
The WOMAC questionnaire has been used to assess subjects with OA of the hip or knee and consists of 24 items divided into 3 subscales: self-perception of pain (5 items), joint stiffness (2 items), and functional performance (17 items) during the previous 72 h.
The WOMAC questionnaire were measured on the day before their surgery.
The cognitive abilities screening instrument (CASI)
Time Frame: The CASI questionnaire were measured on the day before their surgery.
The CASI has been commonly used in dementia research and clinical practice to evaluate a subject's cognitive abilities.
The CASI questionnaire were measured on the day before their surgery.
Glia mediators of neuroinflammation
Time Frame: All blood and CSF samples were obtained before spinal anesthesia.
Glia mediators of neuroinflammation include interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor α (TNF α), BDNF and fractalkine.
All blood and CSF samples were obtained before spinal anesthesia.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The geriatric depression scale (GDS-15)
Time Frame: The GDS-15 questionnaire were measured on the day before their surgery.
The GDS-15 was used for evaluation of emotion especially for participant of age > 65. years old.
The GDS-15 questionnaire were measured on the day before their surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Chun-Hsien Wen, Physician, Kaohsiung Veterans General Hospital.
  • Study Director: Chen-Hsiu Chen, Physician, Kaohsiung Veterans General Hospital.
  • Study Director: Yuan-Yi Chia, Director, Kaohsiung Veterans General Hospital.
  • Study Chair: Chih-Chi Tsai, RA, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2019

Primary Completion (Actual)

April 21, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS19-CT2-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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