Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
Duke University Pain Prevention: Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee
4 other identifiers
interventional
412
1 country
1
Brief Summary
Osteoarthritis (OA) occurs when the cartilage between two bones becomes worn down, and the bones begin to rub against each other in the joint. This often leads to pain, swelling, decreased joint motion, and the formation of bone spurs (tiny growths of new bone). Being overweight increases the risk of developing OA and fastens disease progression. This study will evaluate two different programs, lifestyle behavioral weight management and pain-coping skills training, in reducing the effects of knee OA in obese individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 20, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 25, 2018
August 1, 2013
5.7 years
March 20, 2006
October 24, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
Psychological impairment
Measured immediately, 6 months, and 12 months following treatment: pain
Physical disability
Measured immediately, 6 months, and 12 months following treatment: pain
Joint stiffness
Measured immediately, 6 months, and 12 months following treatment: pain
Activity level
Measured immediately, 6 months, and 12 months following treatment: pain
Physical activities
Measured immediately, 6 months, and 12 months following treatment: pain
Secondary Outcomes (2)
Physiological measures of disease activity
Measured immediately, 6 months, and 12 months following treatment: pain
Gait measures
Measured immediately, 6 months, and 12 months following treatment: pain
Study Arms (4)
1
EXPERIMENTALParticipants will partake in a lifestyle behavioral weight management program for 24 weeks.
2
EXPERIMENTALParticipants will partake in pain-coping skills training for 24 weeks.
3
EXPERIMENTALParticipants will partake in lifestyle behavioral weight management program plus pain-coping skills training for 24 weeks.
4
ACTIVE COMPARATORParticipants will receive standard care for 24 weeks.
Interventions
The lifestyle behavioral weight management program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain. Participants will attend 12 weekly group sessions, followed by 6 every-other-week group sessions.
Eligibility Criteria
You may qualify if:
- Meets the American College of Rheumatology criteria for OA
- Radiographic evidence of OA affecting one or both knees
- Complaints of chronic knee pain (pain on most days for at least 6 months prior to study entry)
- No other major weight-bearing joint affected by OA
You may not qualify if:
- Any significant medical condition or disease that would make study participation unsafe or increase the risk of a significant adverse experience during the course of the study (e.g., myocardial infarction in the 6 months prior to study entry)
- Currently involved in a regular exercise program
- An abnormal cardiac response to exercise, such as exercise-induced BT or an abnormal blood pressure response
- A body mass index (BMI) greater than 42
- A non-OA inflammatory arthropathy
- Currently using oral corticosteroids on a regular basis
- Anticipate to have a knee surgery in the next 18 months (or before the anticipated date of their study completion)
- Knee surgery (arthroscopic or knee replacement) within a year of enrollment
- Intraarticular steroid or hyaluronan knee injections in one of both knees within 3 months of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University Morreene Rd. Clinic
Durham, North Carolina, 27705, United States
Related Publications (1)
Huebner JL, Landerman LR, Somers TJ, Keefe FJ, Guilak F, Blumenthal JA, Caldwell DS, Kraus VB. Exploratory secondary analyses of a cognitive-behavioral intervention for knee osteoarthritis demonstrate reduction in biomarkers of adipocyte inflammation. Osteoarthritis Cartilage. 2016 Sep;24(9):1528-34. doi: 10.1016/j.joca.2016.04.002. Epub 2016 Apr 16.
PMID: 27090577DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Keefe, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2006
First Posted
March 22, 2006
Study Start
January 1, 2004
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
October 25, 2018
Record last verified: 2013-08