Clinical trial NCT02664896: Pain Phenotypes in Knee Osteoarthritis
Official title: Determination of Pain Phenotypes in Older Adults With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Pain
Keywords: Knee pain
Knee Osteoarthritis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 187
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subject population will include 50-85 year olds who experience knee pain and have been diagnosed with knee osteoarthritis by a physician. Additionally, a healthy control cohort will be recruited. This cohort will also be 50-85 years old but will deny having any pain and will not be diagnosed with knee osteoarthritis.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Pain Measured by Visual Analog Scale (VAS)
timeFrame: Baseline
Secondary outcomes:
measure: Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
timeFrame: Baseline
measure: Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
timeFrame: Baseline
measure: Knee Range of Motion
timeFrame: Baseline
measure: Girth for Swelling Measurement of Knee
timeFrame: Baseline
measure: Tactile Threshold Test
timeFrame: Baseline
measure: Two Point Discrimination Test
timeFrame: Baseline
measure: Gait Speed Test
timeFrame: Baseline
measure: Five Time Sit-To-Stand
timeFrame: Baseline
measure: Pressure/Pain Threshold Test
timeFrame: Baseline
measure: Pressure/Pain Threshold Test Conditioned Pain Modulation
timeFrame: Baseline
measure: Laterality Recognition Test
timeFrame: Baseline
measure: Perception of Limb Size Test
timeFrame: Baseline
measure: Comorbidity Index
timeFrame: Baseline
measure: Intermittent and Constant Osteoarthritis Pain: Knee Version
timeFrame: Baseline
measure: KOOS Knee Survey
timeFrame: Baseline
measure: Arthritis Efficacy Scale
timeFrame: Baseline
measure: Tampa Scale for Kinesiophobia
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline
measure: Inflammatory Cytokines
timeFrame: Baseline
measure: Kellgren-Lawrence Grade of Knee Radiographs
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E Stevens-Lapsley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kittelson AJ, Stevens-Lapsley JE, Schmiege SJ. Determination of Pain Phenotypes in Knee Osteoarthritis: A Latent Class Analysis Using Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2016 May;68(5):612-20. doi: 10.1002/acr.22734.
citation: Kittelson AJ, George SZ, Maluf KS, Stevens-Lapsley JE. Future directions in painful knee osteoarthritis: harnessing complexity in a heterogeneous population. Phys Ther. 2014 Mar;94(3):422-32. doi: 10.2522/ptj.20130256. Epub 2013 Oct 31.
citation: Brandt KD, Dieppe P, Radin EL. Etiopathogenesis of osteoarthritis. Rheum Dis Clin North Am. 2008 Aug;34(3):531-59. doi: 10.1016/j.rdc.2008.05.011.
citation: Maillefert JF, Roy C, Cadet C, Nizard R, Berdah L, Ravaud P. Factors influencing surgeons' decisions in the indication for total joint replacement in hip osteoarthritis in real life. Arthritis Rheum. 2008 Feb 15;59(2):255-62. doi: 10.1002/art.23331.
citation: McAlindon TE, Cooper C, Kirwan JR, Dieppe PA. Knee pain and disability in the community. Br J Rheumatol. 1992 Mar;31(3):189-92. doi: 10.1093/rheumatology/31.3.189.