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Mindfulness Therapy for Knee Replacement (POKR-p Trial)
N/A
Waitlist Available
Led By Robert Edwards, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare a mindfulness-based cognitive-behavioral treatment to the standard treatment for patients undergoing total knee arthroplasty, in order to study the long-term effects of the treatment on pain and function.
Eligible Conditions
- Osteoarthritis
- Knee Replacement
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brief Pain Inventory (BPI)
Secondary study objectives
PROMIS-SF
Pain Catastrophizing Scale
Quantitative Sensory Testing (QST)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-based CBTExperimental Treatment1 Intervention
All participants will receive four individual mindfulness-based CBT sessions.
Group II: Treatment as UsualActive Control1 Intervention
All participants will undergo surgery as usual, with no additional intervention.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,584 Total Patients Enrolled
17 Trials studying Osteoarthritis
29,910 Patients Enrolled for Osteoarthritis
Robert Edwards, PhDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
35 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a recent history of drug or alcohol addiction.You have severe Raynaud's disease or severe nerve damage.You have severe inflammation of your blood vessels or significant disease in your blood vessels outside of your heart.You are going to have knee replacement surgery.You have had a heart attack in the last year.You are currently taking oral steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual
- Group 2: Mindfulness-based CBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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