AzTrials
AzTrials

Osteoarthritis, KneeNCT03344913

Biologic Mechanisms for Pain Variation After Physical Activity in Osteoarthritis

A study testing Walking in people with Osteoarthritis, Knee and Pain, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee, Pain, Physical Activity
What is being tested?
Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
7 May 2018to 24 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Bioenergetics, Inflammation, and Protein Expression as Mechanisms for Variation in Pain Sensitivity After Physical Activity in Adults With Knee Osteoarthritis

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.

Read the detailed description

Osteoarthritis (OA) in the knee is characterized by chronic inflammatory pain that is not necessarily associated with the amount of joint damage.1 Clinical practice guidelines recommend physical activity (PA) for osteoarthritis pain,2 but uptake of PA among adults with OA is very low.3 One reason for this is that while PA can reduce pain among adults with lower extremity OA,4,5 it does so differentially, decreasing pain sensitivity for about half of adults with OA but actually increasing pain sensitivity for the other half.6 Further, a recent meta-analysis revealed that engaging in a single type of PA (e.g. aerobic exercise or resistance training) reduces OA knee pain, but there was large heterogeneity in the results which could not be explained by age, sex, BMI, alignment in the knee, disease severity, or baseline pain.5 One of the goals of developing individualized PA interventions for adults with OA is to elucidate the mechanisms by which PA reduces OA pain and for whom PA most effectively diminishes the pain.

Aerobic physical activity, such as walking, increases cellular capacity for energy generation (ATP production) via oxidative phosphorylation up to 2-fold by stimulating mitochondrial biogenesis.7,8 This phenomenon occurs not only in skeletal muscle,7 but also in brain cells,9,10 liver cells,9,11,12 adipose tissue,13 kidney cells,12 and leukocytes14 indicating that PA likely increases metabolic demand systemically. Moreover, PA is thought to create adaptive changes in the activity and/or abundance of proteins involved in processes related to mitochondrial function.8 Mitochondrial function, including energy generation through oxidative phosphorylation; inflammation; and mitochondrial related protein expression are key features in osteoarthritis15,16 and chronic inflammatory pain.17,18 Animal models of inflammatory pain demonstrate a cellular metabolic shift from oxidative phosphorylation to glycolysis in chronic inflammatory states via the pyruvate dehydrogenase kinase 2/4 (PKD2/4)-pyruvate dehydrogenase (PDH)-lactic acid axis.19 This results in an increase in lactic acid production in the affected area. The ensuing acidic microenvironment amplifies the nociceptive response via recruitment of additional pro-algesic proinflammatory cytokines which "activate nociceptors and spinal glia to cause peripheral and central sensitizations, respectively".19 Thus, improvement in the capacity to generate ATP through oxidative phosphorylation, and associated reduction of glycolysis, may reduce pain sensitivity. However, while a large body of animal and correlational data supports a strong link between oxidative potential and pain outcomes, experimental evidence of cause and effect remains sparse, especially in humans.8

The investigators are hypothesizing that individual differences in systemic cellular bioenergetic function, inflammation, and protein expression influence the effect of PA to reduce pain sensitivity in adults with knee OA. The purpose of this quasi-experimental pilot study is to test mitochondrial bioenergetics (oxidative phosphorylation, mitochondrial content) in platelets, inflammation (cytokines) and protein expression as mechanisms for variation in pain sensitivity 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 knee osteoarthritis. The investigators will address the following specific aims and hypotheses in a sample of 40 adults with radiologic evidence of hip or knee OA and 20 age/gender matched healthy controls:

Aim 1: To examine the effects of a six week (three days/week) walking program on pain thresholds in adults with knee OA as compared to healthy controls H1.1: Pain sensitivity (Quantitative Sensory Testing) will increase in approximately 50% of adults with OA and decrease in approximately 50% of adults with OA after acute and long-term PA.

H1.2: Pain sensitivity will decrease in healthy controls after acute and long-term PA.

Aim2: To test the role of mitochondrial bioenergetics (oxidative phosphorylation, mitochondrial content) as a mechanism for variation in pain sensitivity after PA in older adults with knee OA.

H2.1: Pain sensitivity is negatively associated with mitochondrial function (oxidative phosphorylation, mitochondrial content) in platelets at baseline, after acute PA and long-term PA H2.2: Healthy controls will have higher capacity for oxidative phosphorylation in platelets than OA participants.

Aim3: To test the role of inflammation as a mechanism for variation in pain sensitivity after physical activity in older adults with knee OA.

H3.1: Pain sensitivity is positively associated with increased circulating proinflammatory cytokines (c-reactive protein, interleukin (IL)-1, IL-1β, IL-6, IL-10, tumor necrosis factor (TNF)-α, PGES) at baseline, after acute and long-term PA.

Aim 4: To generate hypotheses regarding the role of proteomics in variation in pain sensitivity after physical activity (immediacy following and after six weeks of walking program) Changes in protein expression will depend on the half-life of the protein being expressed which can range from minutes to days.8 Thus, it is important to examine adaptive changes in protein expression in both the short (minutes/day post PA) and long term (days/weeks between bouts of physical activity).

Being tested
Walking
Medical subject headings
Osteoarthritis, Knee, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WalkingBehavioural

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

Study groups in NCT03344913
Study groupRoleWhat they receive
Adults with knee OsteoarthritisActive comparatorwalking 30 minutes per day, three days/week for 6 weeks.
Receives: Behavioral: Walking
Healthy controlsActive comparatorwalking 30 minutes per day, three days/week for 6 weeks.
Receives: Behavioral: Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain sensitivity

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

    Measured: Baseline and immediately after 30 minutes of walking

  2. Pain sensitivity

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

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

Secondary outcomes (6)
  1. platelet mitochondrial function

    platelet oxygen consumption as indicator of cellular energy production via oxidative phosphorylation or glycolysis; mitochondrial copy number; mitochondrial proteins

    Measured: immediately after 30 minutes of walking

  2. platelet mitochondrial function

    platelet oxygen consumption as indicator of cellular energy production via oxidative phosphorylation or glycolysis; mitochondrial copy number; mitochondrial proteins

    Measured: after six weeks of walking for 30 minutes

  3. Inflammatory markers in plasma

    c-reactive protein (CRP), Interleukin (IL)-1, IL-1β, IL-6, IL-10, Tumor Necrosis factor-alpha (TNF-α), prostaglandin-e (PGES)

    Measured: immediately after 30 minutes of walking

  4. Inflammatory markers in plasma

    c-reactive protein (CRP), Interleukin (IL)-1, IL-1β, IL-6, IL-10, Tumor Necrosis factor-alpha (TNF-α), prostaglandin-e (PGES)

    Measured: after six weeks of walking for 30 minutes

  5. Platelet protein signatures

    Platelet protein signatures will be explored using nanocapillary liquid chromatography-mass spectrometry (LC-MS/MS) coupled to an Orbitrap MS that combines two mass analyzers to allow simultaneous precursor ion scans from which relative quantitative data is derived between two groups (hi and low pain groups) and fragmentation data from which peptide sequence matches are made.

    Measured: immediately after 30 minutes of walking

  6. Platelet protein signatures

    Platelet protein signatures will be explored using nanocapillary liquid chromatography-mass spectrometry (LC-MS/MS) coupled to an Orbitrap MS that combines two mass analyzers to allow simultaneous precursor ion scans from which relative quantitative data is derived between two groups (hi and low pain groups) and fragmentation data from which peptide sequence matches are made.

    Measured: after six weeks of walking for 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start7 May 2018
  3. Primary completion24 Aug 2022
  4. Study completion24 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03344913
Sponsor's protocol ID
HP-00076861
Other IDs
1P30NR016579-01
Status last verified
Sep 2022
First submitted
8 Nov 2017
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a pilot study with a very small sample size.

Publications

  • 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.

    PubMed 35302959

Questions about this trial

What is this clinical trial studying?

A study testing Walking in people with Osteoarthritis, Knee and Pain, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain sensitivity (time frame: Baseline and immediately after 30 minutes of walking). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03344913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in