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: Completed
• Conditions: Osteoarthritis, Knee; Knee Replacement
• Intervention / Treatment: Behavioral: Mindfulness-based Cognitive Behavioral Therapy

Detailed Description

The present study seeks to collect pilot data on a brief mindfulness-based cognitive-behavioral treatment to determine the feasibility of this intervention and its potential benefits. The study includes 6 total contacts, 1 visit before surgery and 3 after surgery, and 2 phone calls. The last visit will be about 6 months after surgery. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold. The research takes place at the Brigham & Women's Pain Management Center, 850 Boylston St, Chestnut Hill.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital Pain Management Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 45 or older,
2. Meet the American College of Rheumatology criteria for knee OA,
3. Scheduled to undergo total knee arthroplasty,
4. Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

1. Cognitive impairment preventing completion of study assessment procedures.
2. Myocardial infarction within the past 12 months.
3. Presence of Severe Raynaud's or severe neuropathy,
4. Active vasculitis or severe peripheral vascular disease,
5. Current infection,
6. Use of oral steroids,
7. Recent history of substance abuse or dependence,
8. Known anemia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based CBT; All participants will receive four individual mindfulness-based CBT sessions.	Behavioral: Mindfulness-based Cognitive Behavioral Therapy; 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.
No Intervention: Treatment as Usual; All participants will undergo surgery as usual, with no additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI)	Measure of pain severity and pain interference	baseline
Brief Pain Inventory (BPI)	Measure of pain severity and pain interference	6-week
Brief Pain Inventory (BPI)	Measure of pain severity and pain interference	3-months
Brief Pain Inventory (BPI)	Measure of pain severity and pain interference	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Sensory Testing (QST)	Measures of responses to standardized stimuli	baseline
Quantitative Sensory Testing (QST)	Measures of responses to standardized stimuli	3-months
Pain Catastrophizing Scale	Assess catastrophic thinking related to pain	baseline
Pain Catastrophizing Scale	Assess catastrophic thinking related to pain	6-week
Pain Catastrophizing Scale	Assess catastrophic thinking related to pain	3-months
Pain Catastrophizing Scale	Assess catastrophic thinking related to pain	6-months
PROMIS-SF	Measures anxiety and depression symptoms	baseline
PROMIS-SF	Measures anxiety and depression symptoms	6-week
PROMIS-SF	Measures anxiety and depression symptoms	3-months
PROMIS-SF	Measures anxiety and depression symptoms	6-months
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)	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)	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)	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)	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: Brigham and Women's Hospital
• Investigators: Principal Investigator: Robert Edwards, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Pester BD, Wilson JM, Yoon J, Lazaridou A, Schreiber KL, Cornelius M, Campbell CM, Smith MT, Haythornthwaite JA, Edwards RR, Meints SM. Brief Mindfulness-Based Cognitive Behavioral Therapy is Associated with Faster Recovery in Patients Undergoing Total Knee Arthroplasty: A Pilot Clinical Trial. Pain Med. 2023 Jun 1;24(6):576-585. doi: 10.1093/pm/pnac183.

Helpful Links

• Local site recruitment link

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CBT
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2010P000978-p

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No