Osteoarthritis, KneePOKR-pNCT04328701

Prediction of Outcomes Following Total Knee Replacement- Pilot

A study testing Mindfulness-based Cognitive Behavioral Therapy in people with Osteoarthritis, Knee and Knee Replacement, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 100 years
Conditions the study is for: Osteoarthritis, Knee, Knee Replacement
What is being tested?: Mindfulness-based Cognitive Behavioral Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2018to 30 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 45 or older,
Meet the American College of Rheumatology criteria for knee OA,
Scheduled to undergo total knee arthroplasty,
Facility with the English language that is adequate to complete study procedures

Who cannot join

Cognitive impairment preventing completion of study assessment procedures.
Myocardial infarction within the past 12 months.
Presence of Severe Raynaud's or severe neuropathy,
Active vasculitis or severe peripheral vascular disease,
Current infection,
Use of oral steroids,
Recent history of substance abuse or dependence,
Known anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital Pain Management Center
Chestnut Hill, Massachusetts, 02467

Other trials in United States

About this study

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.

Read the 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
Being tested: Mindfulness-based Cognitive Behavioral Therapy
Keywords: CBT
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-based Cognitive Behavioral TherapyBehavioural
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.

Study groups in NCT04328701
Study group	Role	What they receive
Mindfulness-based CBT	Experimental	All participants will receive four individual mindfulness-based CBT sessions. Receives: Behavioral: Mindfulness-based Cognitive Behavioral Therapy
Treatment as Usual	No intervention	All participants will undergo surgery as usual, with no additional intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Measured: baseline
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Measured: 6-week
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Measured: 3-months
Brief Pain Inventory (BPI)
Measure of pain severity and pain interference
Measured: 6-months

Secondary outcomes (14)

Quantitative Sensory Testing (QST)
Measures of responses to standardized stimuli
Measured: baseline
Quantitative Sensory Testing (QST)
Measures of responses to standardized stimuli
Measured: 3-months
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Measured: baseline
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Measured: 6-week
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Measured: 3-months
Pain Catastrophizing Scale
Assess catastrophic thinking related to pain
Measured: 6-months
PROMIS-SF
Measures anxiety and depression symptoms
Measured: baseline
PROMIS-SF
Measures anxiety and depression symptoms
Measured: 6-week
PROMIS-SF
Measures anxiety and depression symptoms
Measured: 3-months
PROMIS-SF
Measures anxiety and depression symptoms
Measured: 6-months
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.
Measured: baseline
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.
Measured: 6-week
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.
Measured: 3-months
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.
Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201830 Dec 2023

First posted31 Mar 2020
Study start1 Apr 2018
Primary completion30 Apr 2021
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04328701
Sponsor's protocol ID: 2010P000978-p
Acronym: POKR-p
Status last verified: May 2026
First submitted: 3 Feb 2020
Last updated: 20 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36394250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prediction of Outcomes Following Total Knee Replacement- Pilot
ClinicalTrials.gov ID: NCT04328701
Acronym / sponsor ID: POKR-p / 2010P000978-p
Conditions: Osteoarthritis, Knee, Knee Replacement
Keywords: CBT
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 30 Apr 2021 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 31 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Mindfulness-based CBT	Experimental	Behavioral: Mindfulness-based Cognitive Behavioral TherapyAll participants will receive four individual mindfulness-based CBT sessions.
Treatment as Usual	No intervention	–All participants will undergo surgery as usual, with no additional intervention.

Who may qualify

Ages: 45 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 45 or older,
Meet the American College of Rheumatology criteria for knee OA,
Scheduled to undergo total knee arthroplasty,
Facility with the English language that is adequate to complete study procedures

Key exclusion criteria (8 listed)

Cognitive impairment preventing completion of study assessment procedures.
Myocardial infarction within the past 12 months.
Presence of Severe Raynaud's or severe neuropathy,
Active vasculitis or severe peripheral vascular disease,
Current infection,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-based Cognitive Behavioral TherapyMindfulness-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.	Behavioural	Mindfulness-based CBT

Primary outcome

Brief Pain Inventory (BPI)
Time frame: baseline
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Time frame: 6-week
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Time frame: 3-months
Measure of pain severity and pain interference
Brief Pain Inventory (BPI)
Time frame: 6-months
Measure of pain severity and pain interference

14 secondary outcomes

Quantitative Sensory Testing (QST)
Time frame: baseline
Quantitative Sensory Testing (QST)
Time frame: 3-months
Pain Catastrophizing Scale
Time frame: baseline
Pain Catastrophizing Scale
Time frame: 6-week
Pain Catastrophizing Scale
Time frame: 3-months
Pain Catastrophizing Scale
Time frame: 6-months
PROMIS-SF
Time frame: baseline
PROMIS-SF
Time frame: 6-week
PROMIS-SF
Time frame: 3-months
PROMIS-SF
Time frame: 6-months
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time frame: baseline
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time frame: 6-week
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time frame: 3-months
The Western Ontario McMaster Universities Osteoarthritis Scale (WOMAC)
Time frame: 6-months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Derived from this study: PubMed 36394250Pester 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.
Local site recruitment linkLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Edwards, PhD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Cognitive Behavioral Therapy in people with Osteoarthritis, Knee and Knee Replacement, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (BPI) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04328701, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.