Pain Reprocessing Therapy in Post-Operative Knee Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pain reprocessing therapy (PRT)
- Usual care
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Hospital for Special Surgery, New York
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov