NCT04328701

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

February 3, 2020

Last Update Submit

February 8, 2023

Conditions

Osteoarthritis, KneeKnee Replacement

Keywords

CBT

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (14)

  • Quantitative Sensory Testing (QST)

    baseline

  • Quantitative Sensory Testing (QST)

    3-months

  • Pain Catastrophizing Scale

    baseline

  • Pain Catastrophizing Scale

    6-week

  • Pain Catastrophizing Scale

    3-months

  • +9 more secondary outcomes

Study Arms (2)

Mindfulness-based CBT

EXPERIMENTAL

All participants will receive four individual mindfulness-based CBT sessions.

Behavioral: Mindfulness-based Cognitive Behavioral Therapy

Treatment as Usual

NO INTERVENTION

All participants will undergo surgery as usual, with no additional intervention.

Interventions

Mindfulness-based Cognitive Behavioral TherapyBEHAVIORAL

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.

Mindfulness-based CBT

Eligibility Criteria

Age45 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (1)

  • 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.

    PMID: 36394250DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Robert Edwards, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: All participants will undergo quantitative sensory testing, physical functioning testing, and pain-related outcomes assessment. Participants in the intervention arm will undergo brief mindfulness-based cognitive behavioral sessions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

February 3, 2020

First Posted

March 31, 2020

Study Start

April 1, 2018

Primary Completion

April 30, 2021

Study Completion

December 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)