Pain Reprocessing Therapy for persistent knee pain after knee replacement
Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain
This trial will test whether Pain Reprocessing Therapy (PRT) delivered by video can reduce persistent knee pain in adults who still have meaningful pain three months after knee replacement.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06800209 on ClinicalTrials.gov |
What this trial studies
Adults with chronic pre-operative knee pain who continue to have pain three months after a primary knee replacement are randomized to eight weekly telehealth PRT sessions or to usual post-operative care. Participants complete questionnaires on pain intensity, function, anxiety, depression, and sleep, and a subset may undergo optional EEG to measure brain activity related to pain. The PRT intervention uses cognitive, exposure-based, and somatic techniques to help patients reconceptualize pain as reversible brain-driven activity rather than ongoing tissue damage. Outcomes and mediation analyses will measure clinical effects at post-treatment and over longitudinal follow-up and test psychological and neurobiological mechanisms.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults who had a primary knee replacement, reported chronic knee pain before surgery, and continue to have moderate pain (average ≥4/20 and specific WOMAC criteria) at three months post-op.
Not a fit: Patients without ongoing pain at three months, those who had a revision rather than a primary knee replacement, those unwilling to use telehealth, or those with exclusionary psychiatric or medical conditions are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, PRT could provide a scalable, non-drug therapy that reduces or even eliminates chronic post-operative knee pain and improves mood and sleep.
How similar studies have performed: A prior randomized trial of PRT for chronic back pain (N=151) showed large benefits (about 66% pain-free or nearly pain-free post-treatment versus <20% for controls), but PRT has not yet been tested for chronic post-operative knee pain or widely by telehealth.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Active_not_recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Allina Nocon, PhD
- Email: Complexjoint@hss.edu
- Phone: 212-774-2572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.