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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04328701
Other study ID # 2010P000978-p
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 2023

Study information

Verified date February 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 2023
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Brigham and Women's Hospital Pain Management Center Chestnut Hill Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory (BPI) Measure of pain severity and pain interference baseline
Primary Brief Pain Inventory (BPI) Measure of pain severity and pain interference 6-week
Primary Brief Pain Inventory (BPI) Measure of pain severity and pain interference 3-months
Primary Brief Pain Inventory (BPI) Measure of pain severity and pain interference 6-months
Secondary Quantitative Sensory Testing (QST) Measures of responses to standardized stimuli baseline
Secondary Quantitative Sensory Testing (QST) Measures of responses to standardized stimuli 3-months
Secondary Pain Catastrophizing Scale Assess catastrophic thinking related to pain baseline
Secondary Pain Catastrophizing Scale Assess catastrophic thinking related to pain 6-week
Secondary Pain Catastrophizing Scale Assess catastrophic thinking related to pain 3-months
Secondary Pain Catastrophizing Scale Assess catastrophic thinking related to pain 6-months
Secondary PROMIS-SF Measures anxiety and depression symptoms baseline
Secondary PROMIS-SF Measures anxiety and depression symptoms 6-week
Secondary PROMIS-SF Measures anxiety and depression symptoms 3-months
Secondary PROMIS-SF Measures anxiety and depression symptoms 6-months
Secondary The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) 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. baseline
Secondary The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) 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. 6-week
Secondary The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) 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. 3-months
Secondary The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC) 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. 6-months
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