Pain Reprocessing Therapy in Post-Operative Knee Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pain reprocessing therapy (PRT)
BehavioralA promising new psychotherapy for chronic pain.
Usual care
Other interventionParticipants will be asked to continue to do whatever they are currently doing to manage their pain.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Pain reprocessing therapy (PRT)Experimental treatment 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity
Last-week average pain intensity is assessed using the 5-item pain subscale of the 12-item shortened version (ShortMAC) of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The ShortMAC assesses pain severity and its impact on functioning. It consists of 12 total items, including 5 pain items and 7 pain interference items. The 5 pain items measure pain on a scale of 0-4, with 0 indicating no pain and 4 indicating extreme pain.
Time frame
Approximately 12, 18, and 26 weeks post-randomizationSecondary outcomes
1
Pain interference
Pain interference is assessed using the 7-item pain interference subscale of the 12-item shortened version (ShortMAC) of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The ShortMAC assesses pain severity and its impact on functioning. It consists of 12 total items including 5 pain items and 7 pain interference items. The 7 pain interference items measure pain interference in the last week on a scale of 0-4, with 0 indicating no difficulty and 4 indicating extreme difficulty or inability to perform an activity.
Time frame
Approximately 12, 18, and 26 weeks post-randomization2
Depression
Depression is assessed using the 8-item depression subscale of the Patient-Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. Each item in the PROMIS-SF depression subscale is rated on a 5-point scale of 1 (never) to 5 (always).
Time frame
Approximately 12, 18, and 26 weeks post-randomization3
Anxiety
Anxiety is assessed using the 8-item anxiety subscale of the Patient-Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. Each item in the PROMIS-SF anxiety subscale is rated on a 5-point scale of 1 (never) to 5 (always).
Time frame
Approximately 12, 18, and 26 weeks post-randomization4
Fatigue
Fatigue is assessed using the 8-item sleep disturbance subscale of the Patient-Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. 7 of the 8 items in the PROMIS-SF sleep disturbance subscale are rated on a 5-point scale of 1 (not at all) to 5 (very much) while 1 item is rated on a 5-point scale of 1 (very poor) to 5 (very good).
Time frame
Approximately 12, 18, and 26 weeks post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Hospital for Special Surgery, New York
Collaborator
University of Colorado, Denver
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov