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Completed

NCT Number: NCT02664896

Pain Phenotypes in Knee Osteoarthritis

Recently, the medical community has learned damage to the knee joint may be one of many possible reasons for pain in knee osteoarthritis. Psychological factors and other aspects of brain function seem to play an important role in the pain experience. Although research studies have examined these factors on an individual basis, no study has examined all of these factors in the same population. Furthermore, some measures of brain function- having to do with perception of the painful body part- have yet to be examined in knee osteoarthritis. The investigators plan to study many of these variables in a group of people with knee osteoarthritis, as well in some healthy controls (without knee pain), in order to establish the relative importance of these measures in contributing to pain, as well as validate new measures of perception in people with knee osteoarthritis. We also plan to use a statistical tool- known as latent profile analysis- to look at subgroups of knee osteoarthritis pain. The hypothesis is that different people experience pain in knee osteoarthritis for different reasons. This study will be the first study to use all of these different variables- which can be reproduced in a clinical setting- to look for different subgroups of knee osteoarthritis pain. Ultimately, the goal is to help clinicians better prioritize and target interventions to individual patients. The investigators believe this will lead to better outcomes and fewer treatment complications currently associates with pharmaceutical and surgical interventions that are widely used to treat knee osteoarthritis.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

In a 2011 statement to the Food and Drug Administration, the Osteoarthritis Research Society International (OARSI) identified the "phenotyping" of OA pain as a research priority to "better target pain therapies to individual patients." Successful identification of pain phenotypes will allow new interventions to be tested in homogeneous populations of patients presenting with similar pain pathophysiology, ultimately enhancing treatment effects in defined populations for whom interventions are determined safe and effective. Clinical populations of knee OA are clearly heterogeneous, spanning wide age ranges and encompassing patients with a wide variety of functional abilities. The pain experience in knee OA may be similarly individualized and complex; some patients may present with pain that appears attributable to classic signs of joint damage, while others may present with pain due to psychological distress or central mechanisms. Changes in somatosensory processing and pain threshold are also known to occur with aging. However, the scientific community has yet to examine these variables concurrently in the same study population. Therefore, the relative importance of each of these measures in determining pain severity across the lifespan is unknown. It is also unknown whether these variables (or interactions between variables) are representative of different pain phenotypes in knee OA. This is an important yet unresolved question; a patient with high levels of psychological distress and low levels of joint damage may warrant a different intervention strategy than the traditional knee-directed approach. On the other hand, someone with increased psychological distress in addition to severe joint damage may benefit from traditional interventions that are further augmented with other impairment-specific interventions. This sort of targeted approach is the topic of current research in other chronic pain populations, where a similar conceptual model, composed of peripheral, psychological and central components to the pain experience (among others), is recognized.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50-85
  • Diagnosed with Knee Osteoarthritis by a physician or by ACR clinical criteria

Exclusion criteria

  • sensory dysfunction due to injury (i.e. known nerve damage)
  • neurological diagnosis affecting sensory or motor function (e.g. stroke, Parkinson's Disease, multiple sclerosisetc.)

Healthy Volunteers eligibility criteria:

  • Age 50-85
  • Do not possess knee osteoarthritis diagnosis
  • do not have knee pain
  • do not have a history major knee trauma or lower extremity trauma or surgery
  • do not have any other pain condition

Treatment and study plan

Knee Osteoarthritis

Other

Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs.

Healthy Control

Other

Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements.

Primary outcomes

  1. Knee Pain Measured by Visual Analog Scale (VAS)

    Time frame: Baseline

Secondary outcomes

  1. Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter

    Time frame: Baseline

  2. Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter

    Time frame: Baseline

  3. Knee Range of Motion

    Time frame: Baseline

  4. Girth for Swelling Measurement of Knee

    Time frame: Baseline

  5. Tactile Threshold Test

    Time frame: Baseline

  6. Two Point Discrimination Test

    Time frame: Baseline

  7. Gait Speed Test

    Time frame: Baseline

  8. Five Time Sit-To-Stand

    Time frame: Baseline

  9. Pressure/Pain Threshold Test

    Time frame: Baseline

  10. Pressure/Pain Threshold Test Conditioned Pain Modulation

    Time frame: Baseline

  11. Laterality Recognition Test

    Time frame: Baseline

  12. Perception of Limb Size Test

    Time frame: Baseline

  13. Comorbidity Index

    Time frame: Baseline

  14. Intermittent and Constant Osteoarthritis Pain: Knee Version

    Time frame: Baseline

  15. KOOS Knee Survey

    Time frame: Baseline

  16. Arthritis Efficacy Scale

    Time frame: Baseline

  17. Tampa Scale for Kinesiophobia

    Time frame: Baseline

  18. Pain Catastrophizing Scale

    Time frame: Baseline

  19. Center for Epidemiologic Studies Depression Scale

    Time frame: Baseline

  20. Inflammatory Cytokines

    Time frame: Baseline

    IL-1beta, IL-6, IL-8, TNF, C-Reactive Protein

  21. Kellgren-Lawrence Grade of Knee Radiographs

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Determination of Pain Phenotypes in Older Adults With Knee Osteoarthritis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2016
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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