Pain Phenotypes in Knee Osteoarthritis

Pain Clinical Trial

Official title:

Determination of Pain Phenotypes in Older Adults With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664896
• Other study ID #: 12-1188
• Status: Completed
• Phase: N/A
• First received: December 18, 2015
• Last updated: June 14, 2016
• Start date: April 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• Knee Osteoarthritis
Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs.
• Healthy Control
Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements.

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain Measured by Visual Analog Scale (VAS)		Baseline	No
Secondary	Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter		Baseline	No
Secondary	Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter		Baseline	No
Secondary	Knee Range of Motion		Baseline	No
Secondary	Girth for Swelling Measurement of Knee		Baseline	No
Secondary	Tactile Threshold Test		Baseline	No
Secondary	Two Point Discrimination Test		Baseline	No
Secondary	Gait Speed Test		Baseline	No
Secondary	Five Time Sit-To-Stand		Baseline	No
Secondary	Pressure/Pain Threshold Test		Baseline	No
Secondary	Pressure/Pain Threshold Test Conditioned Pain Modulation		Baseline	No
Secondary	Laterality Recognition Test		Baseline	No
Secondary	Perception of Limb Size Test		Baseline	No
Secondary	Comorbidity Index		Baseline	No
Secondary	Intermittent and Constant Osteoarthritis Pain: Knee Version		Baseline	No
Secondary	KOOS Knee Survey		Baseline	No
Secondary	Arthritis Efficacy Scale		Baseline	No
Secondary	Tampa Scale for Kinesiophobia		Baseline	No
Secondary	Pain Catastrophizing Scale		Baseline	No
Secondary	Center for Epidemiologic Studies Depression Scale		Baseline	No
Secondary	Inflammatory Cytokines	IL-1beta, IL-6, IL-8, TNF, C-Reactive Protein	Baseline	No
Secondary	Kellgren-Lawrence Grade of Knee Radiographs		Baseline	No