Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06800209

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Outpatient Treatment

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

Follow-up

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

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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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