Biologic Mechanisms for Pain Variation After Physical Activity in Osteoarthritis

NCT03344913 | Completed DMC

• 2 other identifiers: HP-000768611P30NR016579-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) in the knee is characterized by chronic inflammatory pain that is not necessarily related to the amount of joint damage. Clinical practice guidelines recommend physical activity (PA) for osteoarthritis pain, but most adults with OA do not engage in PA. One reason for this is that while PA can reduce OA related joint pain, it does not work for everyone. PA decreases pain sensitivity for about half of adults with OA but increases pain sensitivity for the other half. The investigators are hypothesizing that individual differences in how well cells work to make energy, inflammation, and different proteins available in blood cells explains who PA will work to reduce pain and who it won't among adults with OA. The purpose of this pilot study is to determine if blood cells' ability to make cellular energy, inflammation and proteins help explain the difference about who PA reduces activity for and who it doesn't. The investigators will compare these biologic factors and pain sensitivity before walking, immediately after 30 minutes of walking (i.e. "acute") and after six weeks of walking three times a week for 30 minutes (i.e. "long-term") in adults with hip or knee osteoarthritis. The investigators will also compare these results to adults without OA. The investigators will recruit a sample of 40 adults with radiologic (e.g x-ray or CT scan) evidence of hip or knee OA and 20 age/gender matched healthy adults without OA to address the following study aims: Aim 1: To examine the effects of a six week (three days/week) walking program on pain in adults with OA as compared to healthy controls. Aim 2: To test the cells' ability to make energy as a mechanism for variation in pain after "acute" and "long-term" PA in older adults with lower extremity osteoarthritis. Aim3: To test the role of inflammation as a mechanism for variation in pain after "acute" and "long-term" physical activity in adults with lower extremity osteoarthritis. Aim 4: To generate hypotheses regarding the role of proteomics in variation in pain after "acute" and "long-term" physical activity.

Conditions

Osteoarthritis, Knee; Pain; Physical Activity; Mitochondrial Pathology

Outcome Measures

Primary Outcomes (2)

• Pain sensitivity

  Change from baseline pain threshold/tolerance after 30 minutes of walking

  Baseline and immediately after 30 minutes of walking

• Pain sensitivity

  Change from baseline pain threshold/tolerance after six weeks of walking for 30 minutes three days/week

  Baseline and within 4 weeks after completing six weeks of walking for 30 minutes three days/week

Secondary Outcomes (6)

• platelet mitochondrial function

  immediately after 30 minutes of walking

• platelet mitochondrial function

  after six weeks of walking for 30 minutes

• Inflammatory markers in plasma

  immediately after 30 minutes of walking

• Inflammatory markers in plasma

  after six weeks of walking for 30 minutes

• Platelet protein signatures

  immediately after 30 minutes of walking

Study Arms (2)

Adults with knee Osteoarthritis

ACTIVE COMPARATOR

walking 30 minutes per day, three days/week for 6 weeks.

Behavioral: Walking

Healthy controls

ACTIVE COMPARATOR

walking 30 minutes per day, three days/week for 6 weeks.

Behavioral: Walking

Interventions

Walking BEHAVIORAL

walking 30 minutes per day, three days/week for 6 weeks with a member of study team.

Adults with knee Osteoarthritis; Healthy controls

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with Osteoarthritis:
• Age 50-80
• radiographic evidence of knee osteoarthritis (OA participants)
• self-report current non-smoker
• willing and able to walk for 30 minutes a day three days a week for six weeks at a location that is within 30 minutes from University of Maryland Baltimore
• speaks English
• Healthy Controls:
• Age 50-80
• self-reports no osteoarthritis
• self-report current non-smoker
• willing and able to walk for 30 minutes a day three days a week for six weeks at a location that is within 30 minutes from University of Maryland Baltimore
• speaks English

You may not qualify if:

• unable to pass the evaluation to sign consent
• diagnosis of rheumatoid arthritis
• diagnosis of gout
• diagnosis of heart failure
• diagnosis of chronic obstructive pulmonary disease
• diagnosis of diabetes
• diagnosis of Parkinson's disease
• diagnosis of Alzheimer's disease
• diagnosis of autoimmune disease
• currently taking long-term steroid medications such as methotrexate
• weight less than 110 lbs.
• direct employee of the PI

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Klinedinst NJ, Huang W, Nelson AK, Resnick B, Renn C, Kane MA, Dorsey SG. Inflammatory and Immune Protein Pathways Possible Mechanisms for Pain Following Walking in Knee Osteoarthritis. Nurs Res. 2022 Jul-Aug 01;71(4):328-335. doi: 10.1097/NNR.0000000000000593. Epub 2022 Mar 18.

  PMID: 35302959 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Jennifer Klinedinst, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Adults with knee osteoarthritis and healthy controls will both undergo the same walking intervention. The goal is to examine basic mechanism for pain sensitivity after walking.

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 17, 2017
• Study Start: May 7, 2018
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)