Prediction of Outcomes Following Total Knee Replacement- Pilot

Not Applicable

Active, not recruiting

• Conditions: Knee Replacement; Osteoarthritis, Knee
• Interventions: Behavioral: Mindfulness-based Cognitive Behavioral Therapy

• Registration Number: NCT04328701
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Primary Completion: 2021-04-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based CBT	Mindfulness-based Cognitive Behavioral Therapy	All participants will receive four individual mindfulness-based CBT sessions.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	6-months	Measure of pain severity and pain interference

Secondary Outcome Measures

Name	Time	Method
Quantitative Sensory Testing (QST)	3-months	Measures of responses to standardized stimuli
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)	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.
Pain Catastrophizing Scale	6-months	Assess catastrophic thinking related to pain
PROMIS-SF	6-months	Measures anxiety and depression symptoms

Trial Locations

Locations (1)

Brigham and Women's Hospital Pain Management Center; 🇺🇸 Chestnut Hill, Massachusetts, United States