- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328701
Prediction of Outcomes Following Total Knee Replacement- Pilot (POKR-p)
This study seeks to examine multiple risk factors as predictors of pain and function following total knee arthroplasty (TKA). Risk factors will be measured pre-surgically using psychophysical testing procedures, multimodal evaluation of sleep, standardized questionnaires. Additionally, this study will collect pilot data on a brief mindfulness-based cognitive-behavioral treatment that may help to improve long-term TKA outcomes.
The pilot study compared TKA patients that received brief mindfulness-based cognitive behavioral therapy (MBCBT) to the treatment-as-usual (TAU) group from the parent study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Brigham and Women's Hospital Pain Management Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 45 or older,
- Meet the American College of Rheumatology criteria for knee OA,
- Scheduled to undergo total knee arthroplasty,
- Facility with the English language that is adequate to complete study procedures
Exclusion Criteria:
- Cognitive impairment preventing completion of study assessment procedures.
- Myocardial infarction within the past 12 months.
- Presence of Severe Raynaud's or severe neuropathy,
- Active vasculitis or severe peripheral vascular disease,
- Current infection,
- Use of oral steroids,
- Recent history of substance abuse or dependence,
- Known anemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness-based CBT
All participants will receive four individual mindfulness-based CBT sessions.
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Mindfulness-based CBT methods are based on pain self-management paradigms, and involve the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing), the enhancement of self-efficacy for managing pain, and training in the use of adaptive pain-coping strategies such as relaxation, distraction, and self-talk.
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NO_INTERVENTION: Treatment as Usual
All participants will undergo surgery as usual, with no additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (BPI)
Time Frame: baseline
|
Measure of pain severity and pain interference
|
baseline
|
Brief Pain Inventory (BPI)
Time Frame: 6-week
|
Measure of pain severity and pain interference
|
6-week
|
Brief Pain Inventory (BPI)
Time Frame: 3-months
|
Measure of pain severity and pain interference
|
3-months
|
Brief Pain Inventory (BPI)
Time Frame: 6-months
|
Measure of pain severity and pain interference
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative Sensory Testing (QST)
Time Frame: baseline
|
Measures of responses to standardized stimuli
|
baseline
|
Quantitative Sensory Testing (QST)
Time Frame: 3-months
|
Measures of responses to standardized stimuli
|
3-months
|
Pain Catastrophizing Scale
Time Frame: baseline
|
Assess catastrophic thinking related to pain
|
baseline
|
Pain Catastrophizing Scale
Time Frame: 6-week
|
Assess catastrophic thinking related to pain
|
6-week
|
Pain Catastrophizing Scale
Time Frame: 3-months
|
Assess catastrophic thinking related to pain
|
3-months
|
Pain Catastrophizing Scale
Time Frame: 6-months
|
Assess catastrophic thinking related to pain
|
6-months
|
PROMIS-SF
Time Frame: baseline
|
Measures anxiety and depression symptoms
|
baseline
|
PROMIS-SF
Time Frame: 6-week
|
Measures anxiety and depression symptoms
|
6-week
|
PROMIS-SF
Time Frame: 3-months
|
Measures anxiety and depression symptoms
|
3-months
|
PROMIS-SF
Time Frame: 6-months
|
Measures anxiety and depression symptoms
|
6-months
|
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time Frame: baseline
|
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
|
baseline
|
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time Frame: 6-week
|
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
|
6-week
|
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time Frame: 3-months
|
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
|
3-months
|
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time Frame: 6-months
|
24 items and is a well-validated, widely-used outcomes measure that yields three indices specific to osteoarthritis: 1) pain, 2) disability and 3) joint stiffness, which are sensitive to treatment, with internal consistency coefficients for all scales above 0.8.
|
6-months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010P000978-p
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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