NCT04328701

Prediction of Outcomes Following Total Knee Replacement- Pilot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Knee Replacement

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-04-30
• Completion: 2023-12-01
• First posted: 2020-03-31
• Last updated: 2023-02-10

Locations

1 site across 1 country: United States