Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis
NCT03360500
Arthritis, Behavior
São Carlos, São Paulo, Brazil
View Trial DetailsNCT Number: NCT03033238
The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
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Notify Me45 year–79 year
All sexes
Observational
University of Alabama at Birmingham, Birmingham, Alabama, United States
MOST study participants in the "Existing Cohort" (3,026 subjects) were enrolled in the original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an additional 1,500 "New Cohort" participants with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for "New Cohort" Participants:
Exclusion criteria
for "New Cohort" Participants:
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire
Time frame: Change from baseline (144-month) at 168-month follow-up contact
Incidence of cartilage loss on MRI extending to the bone
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire
Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Self- report
Time frame: Change from baseline (144-month) at 168-month follow-up contact
Worsening cartilage scores, bone marrow lesion, or meniscal damage
Time frame: Change from baseline (144-month) at 168-month follow-up contact
Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment
Time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Self-report
Time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Self-report
University of California, San Francisco
Other
Multicenter Osteoarthritis Study (MOST) Second Renewal
Acronym: MOST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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