Prediction of Outcomes Following Total Knee Replacement- Pilot

Osteoarthritis, Knee Clinical Trial

— POKR-p  

Official title:

Prediction of Outcomes Following Total Knee Replacement- Pilot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04328701
• Other study ID #: 2010P000978-p
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Knee Replacement
• Osteoarthritis, Knee

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

External Links

•   Local site recruitment link