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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00305890 |
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.
Condition | Intervention | Phase |
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Osteoarthritis |
Behavioral: Lifestyle Behavioral Weight Management Program Behavioral: Pain-Coping Skills Training Other: Standard Care |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Duke University Pain Prevention: Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee |
Estimated Enrollment: | 280 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will partake in a lifestyle behavioral weight management program for 24 weeks.
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Behavioral: Lifestyle Behavioral Weight Management Program
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.
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2: Experimental
Participants will partake in pain-coping skills training for 24 weeks.
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Behavioral: Pain-Coping Skills Training
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. |
3: Experimental
Participants will partake in lifestyle behavioral weight management program plus pain-coping skills training for 24 weeks.
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Behavioral: Lifestyle Behavioral Weight Management Program
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.
Behavioral: Pain-Coping Skills Training
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. |
4: Active Comparator
Participants will receive standard care for 24 weeks.
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Other: Standard Care
Standard care will include routine medical care.
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Osteoarthritis is a chronic, degenerative joint disorder that does not have a cure. While OA can occur at almost any joint, it most commonly occurs in the knee. Obesity is a significant risk factor for the development of knee OA and is associated with faster disease progression. Biomechanical inflammation and cognitive behavioral changes related to obesity can exacerbate OA pain and disability. The purpose of this study is to develop more effective ways to treat individuals with knee OA. Specifically, the study will compare the effectiveness of a lifestyle behavioral weight management program, pain-coping skills training, and standard care in improving OA symptoms and day-to-day function in obese individuals with OA in one or both knees.
The study treatment groups will meet for a total of 6 months. Participants will be randomly assigned to one of four conditions: 1) lifestyle behavioral weight management program, 2) pain-coping skills training, 3) lifestyle behavioral weight management program plus pain-coping skills training, or 4) standard care. The lifestyle behavioral weight management program will focus on lifestyle, exercise, attitudes, relationships, and nutrition. The pain-coping skills training will focus on minimizing maladaptive over-reactions and enhancing adaptive strategies to control and decrease pain. Standard care will include routine medical care.
Participants in the first three conditions will attend 12 weekly group sessions, followed by 6 every-other-week group sessions. After completing treatment, participants will receive monthly follow-up telephone calls to facilitate the post-treatment transition. There will be a total of four evaluations during this study: immediately prior to treatment, immediately after treatment, and 6 and 12 months following the end of treatment. During each evaluation, blood and urine will be collected to analyze disease biomarkers. An exercise treadmill test and height, weight, and body mass index measures will be used to assess aerobic fitness. Lower extremity function will be measured with the "Up and Go" performance test. Participants will also be videotaped while walking to evaluate gait and will be asked to fill out a series of questionnaires. Medication use will be reviewed during an interview. During the first evaluation, x-rays will be taken to measure disease activity.
Participants completing the study intervention and all four follow-up evaluations will be eligible to join the second part of the study examining the relationship between food intake, mood, activity level, and pain. Participants will complete a series of questionnaires at baseline and 2-day diaries in which they rate mood, pain, and activity level and they record food intake triggered at random times throughout the day. A follow-up visit to complete additional questionnaires will be conducted 6 months later. Blood samples will also be collected for future analysis of genetic markers of pain sensitivity.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Duke Medical Center ( Dr. Francis Keefe ) |
Study ID Numbers: | P01 AR50245, NIAMS-4927, 1P01AR50245-03 |
Study First Received: | March 20, 2006 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00305890 History of Changes |
Health Authority: | United States: Federal Government |
Body Weight Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Pain Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |