Pain Reprocessing Therapy in Post-Operative Knee Pain
United States110 participantsStarted 2025-08-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity
Timeframe: Approximately 12, 18, and 26 weeks post-randomization
Trial details
NCT IDNCT06800209
SponsorWeill Medical College of Cornell University