NCT06800209 Pain Reprocessing Therapy in Post-Operative Knee Pain
| NCT ID | NCT06800209 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Pain, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2025-08-13 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06800209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06800209 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06800209 currently recruiting?
Yes, NCT06800209 is actively recruiting participants. Contact the research team at Complexjoint@hss.edu for enrollment information.
Where is the NCT06800209 trial being conducted?
This trial is being conducted at Aurora, United States, New York, United States.
Who is sponsoring the NCT06800209 clinical trial?
NCT06800209 is sponsored by University of Colorado, Denver. The trial plans to enroll 110 participants.