Prediction of Outcomes Following Total Knee Replacement- Pilot (POKR-p)

February 8, 2023 updated by: Robert Edwards, Brigham and Women's Hospital

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

Active, not recruiting

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 (Anticipated)

40

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

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

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

45 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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.
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)
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

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

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.

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 (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ANTICIPATED)

December 1, 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)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

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

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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