Pain Phenotypes in Knee Osteoarthritis

NCT02664896 | Completed

• 1 other identifier: 12-1188
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Pain

Keywords

Knee pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Pain Measured by Visual Analog Scale (VAS)

  Baseline

Secondary Outcomes (21)

• 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

Study Arms (2)

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

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

Interventions

Knee Osteoarthritis OTHER

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

Knee Osteoarthritis Cohort

Healthy Control OTHER

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

Healthy Subject Cohort

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

• 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.

  PMID: 26414884 BACKGROUND

• 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.

  PMID: 24179141 BACKGROUND

• 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.

  PMID: 18687271 BACKGROUND

• 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.

  PMID: 18240195 BACKGROUND

• 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.

  PMID: 1540789 BACKGROUND

Biospecimen

Retention: NONE RETAINED

1mL of whole blood will be taken for analysis of inflammatory factors including IL-1beta, IL-6, IL-8, TNF, and C-Reactive Protein. Samples will be stored at University of Colorado Hospital until analysis is complete. Samples will then be destroyed.

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer E Stevens-Lapsley, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 27, 2016
• Study Start: April 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

US (1)