Pain Reprocessing Therapy in Post-Operative Knee Pain

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06800209
Phase
PHASE2
Status
Recruiting

Conditions

  • Knee Pain Chronic
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 29, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pain reprocessing therapy (PRT)
    PRT has five components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend eight 50-minute, therapist-led sessions. Pacing will be weekly, for approximately eight weeks.Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely delivered.
  • Other: Usual Care
    Participants will be asked to continue whatever they are already doing to care for their knee pain. Length of the usual care condition will be eight weeks, the expected completion time of the PRT arm.

Primary Outcome Measure

Pain intensity [ Time Frame: Approximately 12, 18, and 26 weeks post-randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Hospital for Special SurgeryNew YorkNew York10021
Allina Nocon, PhD
212-774-2572
Thomas Sculco, MD (PRINCIPAL_INVESTIGATOR)

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