Pain Reprocessing Therapy (PRT)
BehavioralA promising new psychotherapy for chronic pain.
NCT Number: NCT06800209
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EEG Exclusion Criteria (patients can still be enrolled as long as they meet all other eligibility criteria; however, they will not undergo EEG testing):
A promising new psychotherapy for chronic pain.
Participants will be asked to continue to do whatever they are currently doing to manage their pain.
Other names: Treatment as usual
Time frame: Approximately 12, 18, and 26 weeks post-randomization
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-randomization
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-randomization
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-randomization
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-randomization
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-randomization
Opioid Use is assessed via patient-reported medication logs
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain
Acronym: REJOICE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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