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

Mass General Brigham

Status: Active, not recruiting

Conditions: Knee Replacement; Osteoarthritis, Knee

Treatments: Behavioral: Mindfulness-based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04328701

2010P000978-p

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mindfulness-based CBT

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-based Cognitive Behavioral Therapy

Treatment as Usual

No Intervention group

Description:

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