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

NCT05570240 | Completed

• 1 other identifier: VGHKS19-CT2-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis; Neuroinflammatory Response

Keywords

Chronic pain; Knee osteoarthritis; Cognitive deficits

Outcome Measures

Primary Outcomes (3)

• The Western Ontario and McMaster universities Osteoarthritis Index (WOMAC)

  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)

  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

  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 Outcomes (1)

• The geriatric depression scale (GDS-15)

  The GDS-15 questionnaire were measured on the day before their surgery.

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hopital

Kaohsiung City, Zuoying Dist, 813414, Taiwan

Location

Related Publications (12)

• Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

  PMID: 20699159 RESULT

• Kyrkanides S, Tallents RH, Miller JN, Olschowka ME, Johnson R, Yang M, Olschowka JA, Brouxhon SM, O'Banion MK. Osteoarthritis accelerates and exacerbates Alzheimer's disease pathology in mice. J Neuroinflammation. 2011 Sep 7;8:112. doi: 10.1186/1742-2094-8-112.

  PMID: 21899735 RESULT

• Huang SW, Wang WT, Chou LC, Liao CD, Liou TH, Lin HW. Osteoarthritis increases the risk of dementia: a nationwide cohort study in Taiwan. Sci Rep. 2015 May 18;5:10145. doi: 10.1038/srep10145.

  PMID: 25984812 RESULT

• Li X, Tong Q, Gao J, Liu C; Alzheimer's Disease Neuroimaging Initiative; Liu Y. Osteoarthritis Was Associated With a Faster Decline in Hippocampal Volumes in Cognitively Normal Older People. Front Aging Neurosci. 2020 Aug 14;12:190. doi: 10.3389/fnagi.2020.00190. eCollection 2020.

  PMID: 32922280 RESULT

• Wu L, Wang X, Ye Y, Liu C. Association of Osteoarthritis With Changes in Structural Neuroimaging Markers Over Time Among Non-demented Older Adults. Front Aging Neurosci. 2021 Aug 10;13:664443. doi: 10.3389/fnagi.2021.664443. eCollection 2021.

  PMID: 34447303 RESULT

• Clark AK, Malcangio M. Fractalkine/CX3CR1 signaling during neuropathic pain. Front Cell Neurosci. 2014 May 7;8:121. doi: 10.3389/fncel.2014.00121. eCollection 2014.

  PMID: 24847207 RESULT

• Grace PM, Hutchinson MR, Maier SF, Watkins LR. Pathological pain and the neuroimmune interface. Nat Rev Immunol. 2014 Apr;14(4):217-31. doi: 10.1038/nri3621. Epub 2014 Feb 28.

  PMID: 24577438 RESULT

• Montague K, Malcangio M. The therapeutic potential of targeting chemokine signalling in the treatment of chronic pain. J Neurochem. 2017 May;141(4):520-531. doi: 10.1111/jnc.13927. Epub 2017 Feb 24.

  PMID: 27973687 RESULT

• Subbarayan MS, Joly-Amado A, Bickford PC, Nash KR. CX3CL1/CX3CR1 signaling targets for the treatment of neurodegenerative diseases. Pharmacol Ther. 2022 Mar;231:107989. doi: 10.1016/j.pharmthera.2021.107989. Epub 2021 Sep 4.

  PMID: 34492237 RESULT

• Cappoli N, Tabolacci E, Aceto P, Dello Russo C. The emerging role of the BDNF-TrkB signaling pathway in the modulation of pain perception. J Neuroimmunol. 2020 Dec 15;349:577406. doi: 10.1016/j.jneuroim.2020.577406. Epub 2020 Sep 24.

  PMID: 33002723 RESULT

• Malfait AM, Miller RE, Block JA. Targeting neurotrophic factors: Novel approaches to musculoskeletal pain. Pharmacol Ther. 2020 Jul;211:107553. doi: 10.1016/j.pharmthera.2020.107553. Epub 2020 Apr 18.

  PMID: 32311372 RESULT

• Tang J, Bair M, Descalzi G. Reactive Astrocytes: Critical Players in the Development of Chronic Pain. Front Psychiatry. 2021 May 28;12:682056. doi: 10.3389/fpsyt.2021.682056. eCollection 2021.

  PMID: 34122194 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Cognition Disorders

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chun-Hsien Wen, Physician

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Chen-Hsiu Chen, Physician

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

• Yuan-Yi Chia, Director

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

• Chih-Chi Tsai, RA

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: August 7, 2019
• Primary Completion: April 21, 2021
• Study Completion: April 22, 2021
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

TW (1)