Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis

October 24, 2018 updated by: Duke University

Duke University Pain Prevention: Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Morreene Rd. Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychological impairment
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain
Physical disability
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain
Joint stiffness
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain
Activity level
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain
Physical activities
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain

Secondary Outcome Measures

Outcome Measure
Time Frame
Physiological measures of disease activity
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain
Gait measures
Time Frame: Measured immediately, 6 months, and 12 months following treatment: pain
Measured immediately, 6 months, and 12 months following treatment: pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Francis Keefe, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008156
  • P01AR050245 (U.S. NIH Grant/Contract)
  • NIAMS-4927
  • 1P01AR050245-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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