Pain Phenotypes in Knee Osteoarthritis

Determination of Pain Phenotypes in Older Adults With 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.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Other: Knee Osteoarthritis; Other: Healthy Control

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.

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver, Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee Osteoarthritis Cohort; Subjects with knee osteoarthritis will be asked to participate in the knee osteoarthritis testing session. This group will participate in 1 three hour testing session.	Other: Knee Osteoarthritis; Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs.
Healthy Subject Cohort; Healthy subjects will be asked to participate in the healthy control testing session. This group will participate in 1 two hour testing session.	Other: Healthy Control; Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee Pain Measured by Visual Analog Scale (VAS)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter		Baseline
Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter		Baseline
Knee Range of Motion		Baseline
Girth for Swelling Measurement of Knee		Baseline
Tactile Threshold Test		Baseline
Two Point Discrimination Test		Baseline
Gait Speed Test		Baseline
Five Time Sit-To-Stand		Baseline
Pressure/Pain Threshold Test		Baseline
Pressure/Pain Threshold Test Conditioned Pain Modulation		Baseline
Laterality Recognition Test		Baseline
Perception of Limb Size Test		Baseline
Comorbidity Index		Baseline
Intermittent and Constant Osteoarthritis Pain: Knee Version		Baseline
KOOS Knee Survey		Baseline
Arthritis Efficacy Scale		Baseline
Tampa Scale for Kinesiophobia		Baseline
Pain Catastrophizing Scale		Baseline
Center for Epidemiologic Studies Depression Scale		Baseline
Inflammatory Cytokines	IL-1beta, IL-6, IL-8, TNF, C-Reactive Protein	Baseline
Kellgren-Lawrence Grade of Knee Radiographs		Baseline

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jennifer E Stevens-Lapsley, PT, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Knee pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 12-1188