Pain Phenotypes in Knee Osteoarthritis

June 14, 2016 updated by: University of Colorado, Denver

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Knee Pain Measured by Visual Analog Scale (VAS)
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Time Frame: Baseline
Baseline
Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Time Frame: Baseline
Baseline
Knee Range of Motion
Time Frame: Baseline
Baseline
Girth for Swelling Measurement of Knee
Time Frame: Baseline
Baseline
Tactile Threshold Test
Time Frame: Baseline
Baseline
Two Point Discrimination Test
Time Frame: Baseline
Baseline
Gait Speed Test
Time Frame: Baseline
Baseline
Five Time Sit-To-Stand
Time Frame: Baseline
Baseline
Pressure/Pain Threshold Test
Time Frame: Baseline
Baseline
Pressure/Pain Threshold Test Conditioned Pain Modulation
Time Frame: Baseline
Baseline
Laterality Recognition Test
Time Frame: Baseline
Baseline
Perception of Limb Size Test
Time Frame: Baseline
Baseline
Comorbidity Index
Time Frame: Baseline
Baseline
Intermittent and Constant Osteoarthritis Pain: Knee Version
Time Frame: Baseline
Baseline
KOOS Knee Survey
Time Frame: Baseline
Baseline
Arthritis Efficacy Scale
Time Frame: Baseline
Baseline
Tampa Scale for Kinesiophobia
Time Frame: Baseline
Baseline
Pain Catastrophizing Scale
Time Frame: Baseline
Baseline
Center for Epidemiologic Studies Depression Scale
Time Frame: Baseline
Baseline
Inflammatory Cytokines
Time Frame: Baseline
IL-1beta, IL-6, IL-8, TNF, C-Reactive Protein
Baseline
Kellgren-Lawrence Grade of Knee Radiographs
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer E Stevens-Lapsley, PT, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-1188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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