Clinical trial NCT04328701: Prediction of Outcomes Following Total Knee Replacement- Pilot
Official title: Prediction of Outcomes Following Total Knee Replacement- Pilot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Knee Replacement
Keywords: CBT
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: baseline
measure: Brief Pain Inventory (BPI)
timeFrame: 6-week
measure: Brief Pain Inventory (BPI)
timeFrame: 3-months
measure: Brief Pain Inventory (BPI)
timeFrame: 6-months
Secondary outcomes:
measure: Quantitative Sensory Testing (QST)
timeFrame: baseline
measure: Quantitative Sensory Testing (QST)
timeFrame: 3-months
measure: Pain Catastrophizing Scale
timeFrame: baseline
measure: Pain Catastrophizing Scale
timeFrame: 6-week
measure: Pain Catastrophizing Scale
timeFrame: 3-months
measure: Pain Catastrophizing Scale
timeFrame: 6-months
measure: PROMIS-SF
timeFrame: baseline
measure: PROMIS-SF
timeFrame: 6-week
measure: PROMIS-SF
timeFrame: 3-months
measure: PROMIS-SF
timeFrame: 6-months
measure: The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
timeFrame: baseline
measure: The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
timeFrame: 6-week
measure: The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
timeFrame: 3-months
measure: The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
timeFrame: 6-months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital Pain Management Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.