Skip to main content
OpenTrials
Completed

NCT Number: NCT04328701

Prediction of Outcomes Following Total Knee Replacement- Pilot

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Knee Replacement Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Cognitive Behavioral Therapy

Behavioral

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.

Primary outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: baseline

    Measure of pain severity and pain interference

  2. Brief Pain Inventory (BPI)

    Time frame: 6-week

    Measure of pain severity and pain interference

  3. Brief Pain Inventory (BPI)

    Time frame: 3-months

    Measure of pain severity and pain interference

  4. Brief Pain Inventory (BPI)

    Time frame: 6-months

    Measure of pain severity and pain interference

Secondary outcomes

  1. Quantitative Sensory Testing (QST)

    Time frame: baseline

    Measures of responses to standardized stimuli

  2. Quantitative Sensory Testing (QST)

    Time frame: 3-months

    Measures of responses to standardized stimuli

  3. Pain Catastrophizing Scale

    Time frame: baseline

    Assess catastrophic thinking related to pain

  4. Pain Catastrophizing Scale

    Time frame: 6-week

    Assess catastrophic thinking related to pain

  5. Pain Catastrophizing Scale

    Time frame: 3-months

    Assess catastrophic thinking related to pain

  6. Pain Catastrophizing Scale

    Time frame: 6-months

    Assess catastrophic thinking related to pain

  7. PROMIS-SF

    Time frame: baseline

    Measures anxiety and depression symptoms

  8. PROMIS-SF

    Time frame: 6-week

    Measures anxiety and depression symptoms

  9. PROMIS-SF

    Time frame: 3-months

    Measures anxiety and depression symptoms

  10. PROMIS-SF

    Time frame: 6-months

    Measures anxiety and depression symptoms

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: POKR-p

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Mar 31, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.