Brain MRI for Knee OA

NCT05986513 | Unknown

• 1 other identifier: OAKneeMRI
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

It has been estimated that 300 million people worldwide have osteoarthritis (OA), and this has increased by 97% over the past 25 years. OA is degenerative joint disease that has joint cartilage break down and causes the surrounding bone to change and rub. The pain and loss of mobility experienced by people with knee OA can seriously reduce quality of life, while pain management causes significant healthcare spending. Unfortunately, the pain associated with OA is complex and difficult to treat other than to have a total knee replacement surgery to replace the damaged bone and surrounding tissues with artificial ones. Our research study plans to use advanced magnetic resonance imaging techniques and novel analysis methods to determine if specific parts of the brain are responsible for difficult to describe and diagnose aspects of chronic pain. This study will help us better understand the effects of chronic pain in the brain and the results will help guide future research into new therapeutic options that would focus on relieving the brain dysfunction caused by chronic pain.

Conditions

Chronic Pain; Central Sensitisation; Knee Osteoarthritis

Keywords

functional magnetic resonance imaging; diffusion tensor imaging; nociplastic pain

Outcome Measures

Primary Outcomes (1)

• Group and individual differences at baseline and post-intervention

  The primary objective is to determine if chronic pain, more specifically chronic nociplastic pain, causes neuroplastic brain alterations. It is hypothesized that people with localized chronic pain (OA-Knee) and widespread chronic pain (OA-Knee+Body) would exhibit abnormal brain function (e.g., network connectivity and ROI complexity) and reduced microstructural integrity of brain white matter, that would also be proportionately associated with pain sensitivity and mental state, in comparison to similarly aged individuals with knee osteoarthritis without chronic pain.

  2 hours

Secondary Outcomes (1)

• Presence of neuroinflammation

  2 hours

Study Arms (3)

OA-PF

ACTIVE COMPARATOR

Individuals with knee OA without knee or bodily pain. All participants will complete the same study protocol with pre- post-perturbation MRI scans and pain assessment questionnaires, as well as breath samples collected at multiple time points during the study visit.

Behavioral: Cold Pressor Gel Test

OA-Knee

EXPERIMENTAL

Individuals with knee OA with localized knee pain. All participants will complete the same study protocol with pre- post-perturbation MRI scans and pain assessment questionnaires, as well as breath samples collected at multiple time points during the study visit.

Behavioral: Cold Pressor Gel Test

OA-Knee+Body

EXPERIMENTAL

Individuals with knee OA with localized knee pain and widespread bodily pain. All participants will complete the same study protocol with pre- post-perturbation MRI scans and pain assessment questionnaires, as well as breath samples collected at multiple time points during the study visit.

Behavioral: Cold Pressor Gel Test

Interventions

Cold Pressor Gel Test BEHAVIORAL

This test will allow the research team to induce a painful sensation in participants in a safe, non-invasive, standardized, and short-lasting manner. The protocol for the cold pressor gel test is simple: participants will place their non-dominant hand in the container of cold water for as long as they can up to a maximum of two minutes. If it becomes too painful or uncomfortable during those two minutes, participants can remove their hand from the container. It should be noted again that this is not a treatment for knee OA or chronic pain and will be used to investigate the effects of acute pain in the brain of individuals with a chronic pain condition.

OA-Knee; OA-Knee+Body; OA-PF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis and radiographic evidence of knee OA (by rheumatologist).
• For the two experimental groups (Groups OA-Knee and OA-Knee+Body), participants must have experienced chronic pain related to their knee OA (\>3 months) on most days of each month.
• Participants in Group OA-Knee+Body must:
• Exhibit chronic knee pain and widespread bodily pain at \>3 Michigan Body Map regions.
• Meet the Kosek criteria for nociplastic pain: i) the duration/regionality/type of pain, ii) history of hypersensitivities, iii) comorbidity identification, and iv) evoked pain hypersensitivity \[19\]
• Participants must be able to speak and understand English.

You may not qualify if:

• Unable to provide consent (e.g., poor English language skills, etc.)
• History of liver or kidney disease
• MRI contraindications:
• Pacemaker
• Stent
• Joint prothesis
• Implanted devices
• Claustrophobia
• Pregnant
• Permanent piercings
• Chronic/abusive use of alcohol and/or illicit drugs
• Previous clinical diagnosis of fibromyalgia, a multisite pain disorder, a systemic inflammatory disorder (e.g., rheumatoid arthritis, myopathy), depression, post-traumatic stress disorder
• Previous stroke or moderate/severe traumatic brain injury, subarachnoid hemorrhage, or intracranial hemorrhage
• Use of psychotropic medications
• Control subjects (Group OA-PF) also cannot have a history of chronic pain or knee pain caused by osteoporosis or osteoarthritis

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• McMaster University: collaborator

Study Sites (2)

Imaging Research Centre, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8P 2J5, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

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Related Links

• Bombardier C, Hawker G, Mosher D. (2011) The impact of arthritis in Canada: today and over the next 30 years. The Arthritis Alliance of Canada.
• International Association for the Study of Pain (IASP). IASP Terminology. \[Accessed on 30 November 2022\].

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis, Knee; Nociplastic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Dinesh Kumbhare, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Michael D Noseworthy, PhD, PEng

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinesh Kumbhare, MD, PhD

CONTACT

416 597 3422; dinesh.kumbhare@uhn.ca

Ethan Danielli, PhD

CONTACT

ethan.danielli@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The MRI analysis methods are quantitative and unbiased by convention. Furthermore, they will require the researcher to input the age and sex of the participant and indicate if the participant was a healthy control or experimental to allow for group comparisons, but that will not influence the analyses or outcomes.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Adults who have been clinically diagnosed with knee osteoarthritis (pain free, localized knee pain, or knee and widespread pain) will all receive the same intervention and study protocol.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 31, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)