OsteoarthritisNCT00305890
Weight Management and Coping Skills Training For Patients With Knee Osteoarthritis
A study testing Lifestyle Behavioral Weight Management Program and Pain-Coping Skills Training in people with Osteoarthritis, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lifestyle Behavioral Weight Management Program and Pain-Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Morreene Rd. Clinic
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Lifestyle Behavioral Weight Management Program, Pain-Coping Skills Training, Standard Care
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Behavioral Weight Management ProgramBehavioural
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.
Pain-Coping Skills TrainingBehavioural
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.
Standard CareOther
Standard care will include routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will partake in a lifestyle behavioral weight management program for 24 weeks. Receives: Behavioral: Lifestyle Behavioral Weight Management Program |
| 2 | Experimental | Participants will partake in pain-coping skills training for 24 weeks. Receives: Behavioral: Pain-Coping Skills Training |
| 3 | Experimental | Participants will partake in lifestyle behavioral weight management program plus pain-coping skills training for 24 weeks. Receives: Behavioral: Lifestyle Behavioral Weight Management Program; Behavioral: Pain-Coping Skills Training |
| 4 | Active comparator | Participants will receive standard care for 24 weeks. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological impairment
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Physical disability
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Joint stiffness
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Activity level
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Physical activities
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Secondary outcomes (2)
Physiological measures of disease activity
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Gait measures
Measured: Measured immediately, 6 months, and 12 months following treatment: pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startJan 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Francis Keefe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305890
- Sponsor's protocol ID
- Pro00008156
- Other IDs
- P01AR050245, NIAMS-4927, 1P01AR050245-03
- Status last verified
- Aug 2013
- First submitted
- 20 Mar 2006
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27090577
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke University Pain Prevention: Weight Management and Coping Skills Training For Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00305890
- Acronym / sponsor ID
- Pro00008156
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle Behavioral Weight Management ProgramParticipants will partake in a lifestyle behavioral weight management program for 24 weeks. |
| 2 | Experimental | Behavioral: Pain-Coping Skills TrainingParticipants will partake in pain-coping skills training for 24 weeks. |
| 3 | Experimental | Behavioral: Lifestyle Behavioral Weight Management Program, Behavioral: Pain-Coping Skills TrainingParticipants will partake in lifestyle behavioral weight management program plus pain-coping skills training for 24 weeks. |
| 4 | Active comparator | Other: Standard CareParticipants will receive standard care for 24 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Behavioral Weight Management ProgramThe 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. | Behavioural | 1, 3 |
| Pain-Coping Skills TrainingThe 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. | Behavioural | 2, 3 |
| Standard CareStandard care will include routine medical care. | Other | 4 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Derived from this study: PubMed 27090577Huebner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Keefe, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Behavioral Weight Management Program and Pain-Coping Skills Training in people with Osteoarthritis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological impairment (time frame: Measured immediately, 6 months, and 12 months following treatment: pain). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00305890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.