NCT06800209

Pain Reprocessing Therapy in Post-Operative Knee Pain

Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators recently developed a novel psychological treatment called Pain Reprocessing Therapy (PRT). Using a combination of cognitive, exposure-based, and somatic psychotherapy techniques, PRT aims to promote patients' reconceptualization of pain as due to reversible, non-dangerous brain activity rather than peripheral pathology. Critically, PRT aims to reduce or eliminate pain, rather than merely increase functioning. In the first trial of PRT (N = 151), 66% of patients randomized to PRT were pain-free or nearly pain-free at post-treatment, compared to fewer than 20% of those in the placebo and usual care control groups. This trial was limited to chronic back pain and the efficacy and mechanisms of PRT for chronic post-operative knee pain are unknown. Additionally, how the effects of PRT will generalize to telehealth treatment is not known. Developing scalable, effective, non-pharmacological chronic pain treatments and testing their efficacy in underserved populations is an urgent societal need. Accordingly, this study also tests a remotely delivered PRT intervention. Aim 1 of this study is to test the comparative efficacy of PRT vs. usual care on pain intensity and other pain-related outcomes at post-treatment and longitudinal follow-up. Aim 2 of this study is to test hypothesized psychological and neurobiological mechanisms of PRT with mediation analyses and longitudinal EEG neuroimaging.

Conditions

• Pain, Chronic
• Knee Pain Chronic

Interventions

Type	Name	Description
BEHAVIORAL	Pain reprocessing therapy (PRT)	A promising new psychotherapy for chronic pain.
OTHER	Usual care	Participants will be asked to continue to do whatever they are currently doing to manage their pain.

Timeline

• Start date: 2025-08-13
• Primary completion: 2027-09-30
• Completion: 2028-09-29
• First posted: 2025-01-29
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States