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Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305890
First Posted: March 22, 2006
Last Update Posted: July 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Duke University
  Purpose
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
Osteoarthritis Behavioral: Lifestyle Behavioral Weight Management Program Behavioral: Pain-Coping Skills Training Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duke University Pain Prevention: Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Psychological impairment [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]
  • Physical disability [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]
  • Joint stiffness [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]
  • Activity level [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]
  • Physical activities [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]

Secondary Outcome Measures:
  • Physiological measures of disease activity [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]
  • Gait measures [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ]

Enrollment: 412
Study Start Date: January 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will partake in a lifestyle behavioral weight management program for 24 weeks.
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.
Experimental: 2
Participants will partake in pain-coping skills training for 24 weeks.
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.
Experimental: 3
Participants will partake in lifestyle behavioral weight management program plus pain-coping skills training for 24 weeks.
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.
Active Comparator: 4
Participants will receive standard care for 24 weeks.
Other: Standard Care
Standard care will include routine medical care.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305890


Locations
United States, North Carolina
Duke University Morreene Rd. Clinic
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Francis Keefe, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00305890     History of Changes
Other Study ID Numbers: Pro00008156
P01AR050245 ( U.S. NIH Grant/Contract )
NIAMS-4927
1P01AR050245-03 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2006
First Posted: March 22, 2006
Last Update Posted: July 14, 2014
Last Verified: August 2013

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases