Prediction of Outcomes Following Total Knee Replacement- Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Knee Replacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mindfulness-based CBT

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

Group Type EXPERIMENTAL

Mindfulness-based Cognitive Behavioral Therapy

Intervention Type 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.

Treatment as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based Cognitive Behavioral Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No