Recruiting
Phase 2

PRT vs. Usual Care

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06800209

Conditions

Pain, Chronic

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pain reprocessing therapy (PRT)

Usual care

Study Details

Brief summary:

The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) can help adults with knee pain after knee replacement surgery. The study is comparing PRT to usual care (the regular treatment people get after surgery) to see which works better for relieving pain.

The main questions the study aims to answer are:

1. Does PRT help lower pain in people who have chronic knee pain after knee surgery?
2. How do the effects of PRT compare with usual care in terms of pain relief and other factors such as anxiety, depression, and sleep?
3. How does PRT impact the brain?

Participants will:

1. Be randomly assigned to receive either PRT or usual care.
2. Complete questionnaires about their pain and health.
3. If in the PRT group, have eight weekly therapy sessions over video calls with a therapist.
4. If interested, may also take part in an optional EEG test to measure brain activity related to pain.

Conditions

Pain, Chronic

Knee Pain Chronic

Study ID

NCT06800209

Start date

Aug 13, 2025

Status verified date

Mar, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients are deemed eligible at 3 months post-operatively if: The patient completed a primary knee replacement \[surgery completed without complication and patient exhibits full mechanical joint function, as determined by the treating physician (good range of motion, stability, and wound healing; absence of swelling)\] and patient reports last week average knee pain ≥ 4 of 20 and at least two questions rated 'moderate' on A 12-item shortened version (ShortMAC) of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
  • Reported pre-operative chronic knee pain of at least 6 months duration prior to surgery
  • The procedure was a primary (not a revision) knee replacement
  • Proficient in English

Exclusion Criteria:

  • Patients who are not willing to participate in a telehealth visit.
  • Patients with pre-op chronic pain but who do not have post-operative pain after the three month time period.
  • Active suicidal ideation with intent, recent history of suicide attempt, or self-harm behaviors within the past 5 years (including non-suicidal self-harm).
  • Recent history of inpatient psychiatric hospitalization within the past 5 years.
  • Active, current psychosis or mania.
  • Active, current substance abuse, or problems with substance abuse within the past 2 years.
  • Instability in living conditions or major interfering life events:

  • Major surgery or other major medical event planned in coming 6 months.
  • Uncertain whether they will have suitable conditions for telehealth appointments over the next 2 months, including access to a computer or tablet, reliable high-speed internet, and a quiet, comfortable room that is consistently available.
  • Major, interfering changes in employment or housing anticipated over the next 6 months.
  • Neurological conditions (e.g., Alzheimer's, dementia, mild cognitive impairment, Huntington's disease, multiple sclerosis, cerebral palsy). This will be case-by-case decision made by PI to determine if the condition may interfere with treatment and warrant exclusion.
  • Self-reported diagnosis of an autoimmune disease (e.g., rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, polymyositis, or another autoimmune disorder).
  • Currently or plan to be involved in lawsuits related to pain in next 6 months, currently or plan to apply for any disability payments related to the pain in next 6 months, or received legal settlement or other disability payments related to the pain over past 2 years.

EEG Exclusion Criteria (patients can still be enrolled as long as they meet all other eligibility criteria; however, they will not undergo EEG testing):

  • Are unable or uncomfortable with completing a dry cap EEG.
  • Has had a history of abnormal EEGs.
  • Had bilateral TKA

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pain reprocessing therapy (PRT)

PRT has five components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend eight 50-minute, therapist-led sessions. Pacing will be weekly, for approximately eight weeks.Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely delivered.

other: Usual Care

Participants will be asked to continue whatever they are already doing to care for their knee pain. Length of the usual care condition will be eight weeks, the expected completion time of the PRT arm.

Interventions

Pain reprocessing therapy (PRT)

A promising new psychotherapy for chronic pain.

Usual care

Participants will be asked to continue to do whatever they are currently doing to manage their pain.

Primary outcome measure

  • Pain intensity [ Time Frame: Approximately 12, 18, and 26 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Allina Nocon, PhD

212-774-2572Complexjoint@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Allina Nocon, PhD

212-774-2572

Principal Investigator:

Thomas Sculco, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 5, 2026

Last verified

Mar, 2026

Keywords

  • chronic pain
  • Pain Reprocessing Therapy
  • knee pain
  • total knee replacement
  • Total Knee Arthroplasty
  • mind-body
  • mindfulness
  • TKA
  • PRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.