ClinicalTrials.gg
CompletedNCT03344913Updated Sep 7, 2022

Biologic Mechanisms for Pain Variation After Physical Activity in Osteoarthritis

An interventional study of Walking in Osteoarthritis, Knee, Pain and Physical Activity, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 796 studies in Osteoarthritis, Knee with a site in United States — 110 open to participants now, 153 under way, 15 of them phase 3. Osteoarthritis, Knee · United States.

Enrollment
620th of 691
13 · median 72
Started
2018
with 54 others
No phase
376 of 796
55 open now
Registered
376th of 796
by date

Among the 796 studies in Osteoarthritis, Knee with a site in United States, this one is the 620th largest by enrollment of the 691 interventional ones that give a count, is one of 55 that started in 2018, is one of 376 with no phase, and was the 376th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

110 of the 796 studies in Osteoarthritis, Knee with a site in United States are open now. Recruiting first, the newest first:

105 more — sign in →

All 110 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study 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.

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).

03

Conditions studied

  • Osteoarthritis, Knee
  • Pain
  • Physical Activity
  • Mitochondrial Pathology
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • unable to pass the evaluation to sign consent
  • diagnosis of rheumatoid arthritis
  • diagnosis of gout
  • diagnosis of heart failure
  • diagnosis of
  • diagnosis of diabetes
  • diagnosis of Parkinson's disease
  • diagnosis of Alzheimer's disease
  • diagnosis of disease
  • currently taking long-term medications such as methotrexate
  • weight less than 110 lbs.
  • direct employee of the PI
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    Adults with knee Osteoarthritis

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

    Behavioral: Walking

  • Active comparator
    Healthy controls

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

    Behavioral: Walking

Interventions

  • BehavioralWalking

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

06

What researchers measure

Primary outcomes

  1. Pain sensitivity

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

    Time frame: 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

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

Secondary outcomes

  1. platelet mitochondrial function

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: after six weeks of walking for 30 minutes

07

Study locations

1 site
  • University of Maryland, Baltimore
    Baltimore, Maryland 21201, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No — This is a pilot study with a very small sample size.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Aug 2022, 51 months.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 51 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2017
First posted
Nov 17, 2017
StartActual
May 7, 2018
Primary completionActual
Aug 24, 2022
CompletionActual
Aug 24, 2022
Last update
Sep 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03344913
Responsible party
Jennifer Klinedinst (Associate Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Nov 17, 2017
Start date
May 7, 2018
Primary completion
Aug 24, 2022
Completion
Aug 24, 2022
Last update
Sep 7, 2022

Study contacts

Jennifer Klinedinst, PhD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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