Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00305890
First received: March 20, 2006
Last updated: July 11, 2014
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Physical disability [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]
  • Joint stiffness [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]
  • Activity level [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]
  • Physical activities [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physiological measures of disease activity [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]
  • Gait measures [ Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305890

Locations
United States, North Carolina
Duke University Morreene Rd. Clinic
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis Keefe, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00305890     History of Changes
Other Study ID Numbers: Pro00008156, P01AR050245, NIAMS-4927, 1P01AR50245-03
Study First Received: March 20, 2006
Last Updated: July 11, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014