Osteoarthritis, KneeNCT02664896
Pain Phenotypes in Knee Osteoarthritis
An observational study of Osteoarthritis, Knee and Pain, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- Knee Osteoarthritis
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 50-85
- Diagnosed with Knee Osteoarthritis by a physician or by ACR clinical criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- Knee Osteoarthritis, Healthy Control
- Keywords
- Knee pain, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee OsteoarthritisOther
Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs.
Healthy ControlOther
Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Healthy Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain Measured by Visual Analog Scale (VAS)
Measured: Baseline
Secondary outcomes (21)
Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Measured: Baseline
Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Measured: Baseline
Knee Range of Motion
Measured: Baseline
Girth for Swelling Measurement of Knee
Measured: Baseline
Tactile Threshold Test
Measured: Baseline
Two Point Discrimination Test
Measured: Baseline
Gait Speed Test
Measured: Baseline
Five Time Sit-To-Stand
Measured: Baseline
Pressure/Pain Threshold Test
Measured: Baseline
Pressure/Pain Threshold Test Conditioned Pain Modulation
Measured: Baseline
Laterality Recognition Test
Measured: Baseline
Perception of Limb Size Test
Measured: Baseline
Comorbidity Index
Measured: Baseline
Intermittent and Constant Osteoarthritis Pain: Knee Version
Measured: Baseline
KOOS Knee Survey
Measured: Baseline
Arthritis Efficacy Scale
Measured: Baseline
Tampa Scale for Kinesiophobia
Measured: Baseline
Pain Catastrophizing Scale
Measured: Baseline
Center for Epidemiologic Studies Depression Scale
Measured: Baseline
Inflammatory Cytokines
IL-1beta, IL-6, IL-8, TNF, C-Reactive Protein
Measured: Baseline
Kellgren-Lawrence Grade of Knee Radiographs
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer E Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664896
- Sponsor's protocol ID
- 12-1188
- Status last verified
- Jun 2016
- First submitted
- 18 Dec 2015
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26414884Kittelson 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.
PubMed 24179141Brandt 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.
PubMed 18687271Maillefert 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.
PubMed 18240195McAlindon 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.
PubMed 1540789
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Pain Phenotypes in Older Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02664896
- Acronym / sponsor ID
- 12-1188
- Conditions
- Osteoarthritis, Knee, Pain
- Keywords
- Knee pain, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis Cohort | – | Other: Knee OsteoarthritisSubjects with knee osteoarthritis will be asked to participate in the knee osteoarthritis testing session. This group will participate in 1 three hour testing session. |
| Healthy Subject Cohort | – | Other: Healthy ControlHealthy subjects will be asked to participate in the healthy control testing session. This group will participate in 1 two hour testing session. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 50-85
- Diagnosed with Knee Osteoarthritis by a physician or by ACR clinical criteria
Key exclusion criteria (8 listed)
- 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.)
- Age 50-85
- Do not possess knee osteoarthritis diagnosis
- do not have knee pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee OsteoarthritisQuestionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs. | Other | Knee Osteoarthritis Cohort |
| Healthy ControlQuestionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements. | Other | Healthy Subject Cohort |
Primary outcome
Knee Pain Measured by Visual Analog Scale (VAS)
Time frame: Baseline
21 secondary outcomes
Quadriceps Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Time frame: Baseline
Hamstrings Strength Testing with CSMI Humac Norm Isokinetic Dynamonmeter
Time frame: Baseline
Knee Range of Motion
Time frame: Baseline
Girth for Swelling Measurement of Knee
Time frame: Baseline
Tactile Threshold Test
Time frame: Baseline
Two Point Discrimination Test
Time frame: Baseline
Gait Speed Test
Time frame: Baseline
Five Time Sit-To-Stand
Time frame: Baseline
Pressure/Pain Threshold Test
Time frame: Baseline
Pressure/Pain Threshold Test Conditioned Pain Modulation
Time frame: Baseline
Laterality Recognition Test
Time frame: Baseline
Perception of Limb Size Test
Time frame: Baseline
Comorbidity Index
Time frame: Baseline
Intermittent and Constant Osteoarthritis Pain: Knee Version
Time frame: Baseline
KOOS Knee Survey
Time frame: Baseline
Arthritis Efficacy Scale
Time frame: Baseline
Tampa Scale for Kinesiophobia
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: Baseline
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline
Inflammatory Cytokines
Time frame: Baseline
Kellgren-Lawrence Grade of Knee Radiographs
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 26414884Kittelson 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.
- Background: PubMed 24179141Kittelson 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.
- Background: PubMed 18687271Brandt 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.
- Background: PubMed 18240195Maillefert 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.
- Background: PubMed 1540789McAlindon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain Measured by Visual Analog Scale (VAS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664896, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.