Actively Recruiting
Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain
Led by University of Colorado, Denver · Updated on 2026-03-31
110
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
H
Hospital for Special Surgery, New York
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Pain Reprocessing Therapy (PRT) as a treatment for adults experiencing chronic knee pain after knee replacement surgery. The study compares PRT to usual care to see which approach better relieves pain and affects related factors such as anxiety, depression, and sleep. This phase 2 trial also investigates how PRT may impact brain activity related to pain using EEG neuroimaging. Participants assigned to the PRT group will receive eight weekly 50-minute therapy sessions delivered remotely via video calls. PRT combines education about pain origins, mindfulness techniques, and positive emotional experiences to help patients reconceptualize pain as reversible brain activity rather than physical damage. The usual care group will continue their current pain management routines for the same eight-week period. During the study, participants will complete questionnaires assessing pain intensity, interference, depression, anxiety, fatigue, and opioid use at approximately 12, 18, and 26 weeks after randomization. Those in the PRT group may opt to participate in an EEG test to measure brain activity related to pain. The trial includes safety and follow-up assessments, with study participation lasting several months.
CONDITIONS
Brief Title
Pain Reprocessing Therapy in Post-Operative Knee Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Completed a primary knee replacement surgery at least 3 months prior without complications
- Full mechanical joint function as determined by the treating physician
- Average knee pain of 4 or higher on a 0 to 20 scale in the last week
- At least two moderate ratings on a 12-item shortened Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
- Chronic knee pain lasting at least 6 months before surgery
- Proficient in English
You will not qualify if you...
- Unwilling to participate in telehealth visits
- No post-operative knee pain after 3 months
- Active suicidal thoughts with intent or recent suicide attempts within 5 years
- Recent inpatient psychiatric hospitalization within 5 years
- Current psychosis or mania
- Active or recent substance abuse within 2 years
- Unstable living conditions or major life events interfering with study participation
- Planned major surgery or medical event in next 6 months
- Lack of suitable conditions for telehealth (computer/tablet, internet, quiet room) for next 2 months
- Anticipated major employment or housing changes in next 6 months
- Neurological conditions that may interfere with treatment (evaluated case-by-case)
- Self-reported autoimmune diseases
- Legal actions or disability claims related to pain in past 2 years or planned in next 6 months
- Unable or uncomfortable with dry cap EEG (only excludes EEG testing, not study participation)
- History of abnormal EEGs
- Previous bilateral total knee arthroplasty (TKA) surgery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Approximately 8 weeks
Participants randomized to Pain Reprocessing Therapy attend eight weekly 50-minute remote psychotherapy sessions focusing on reconceptualizing pain as reversible brain activity. Participants in usual care continue their current pain management routine for approximately eight weeks.
8 weekly remote therapy sessions for PRT participants; usual care participants continue their routine without additional study visits
Duration - Approximately 18 weeks following treatment
Participants are assessed for pain intensity, pain interference, depression, anxiety, fatigue, and opioid use at multiple timepoints after treatment completion.
3 follow-up visits approximately at 12, 18, and 26 weeks post-randomization
Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Active, Not Recruiting
2
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
A
Allina Nocon, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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