Pain, ChronicPhase 2REJOICENCT06800209
Pain Reprocessing Therapy in Post-Operative Knee Pain
A Phase 2 study testing Pain reprocessing therapy (PRT) in people with Pain, Chronic and Knee Pain Chronic, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Knee Pain Chronic
- What is being tested?
- Pain reprocessing therapy (PRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2025to 29 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Active, current psychosis or mania.
- Active, current substance abuse, or problems with substance abuse within the past 2 years.
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- Instability in living conditions or major interfering life events:
- Major surgery or other major medical event planned in coming 6 months.
- Uncertain whether they will have suitable conditions for telehealth appointments over the next 2 months, including access to a computer or tablet, reliable high-speed internet, and a quiet, comfortable room that is consistently available.
- Major, interfering changes in employment or housing anticipated over the next 6 months.
- Neurological conditions (e.g., Alzheimer's, dementia, mild cognitive impairment, Huntington's disease, multiple sclerosis, cerebral palsy). This will be case-by-case decision made by PI to determine if the condition may interfere with treatment and warrant exclusion.
- Self-reported diagnosis of an autoimmune disease (e.g., rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, polymyositis, or another autoimmune disorder).
- Currently or plan to be involved in lawsuits related to pain in next 6 months, currently or plan to apply for any disability payments related to the pain in next 6 months, or received legal settlement or other disability payments related to the pain over past 2 years.
- EEG Exclusion Criteria (patients can still be enrolled as long as they meet all other eligibility criteria; however, they will not undergo EEG testing):
- Are unable or uncomfortable with completing a dry cap EEG.
- Has had a history of abnormal EEGs.
- Had bilateral TKA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Allina Nocon, PhD, 212-774-2572
Thomas Sculco, MD
About this study
Official title: Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain
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:
Read more
- Does PRT help lower pain in people who have chronic knee pain after knee surgery?
- How do the effects of PRT compare with usual care in terms of pain relief and other factors such as anxiety, depression, and sleep?
- How does PRT impact the brain?
Participants will:
- Be randomly assigned to receive either PRT or usual care.
- Complete questionnaires about their pain and health.
- If in the PRT group, have eight weekly therapy sessions over video calls with a therapist.
- If interested, may also take part in an optional EEG test to measure brain activity related to pain.
Read the detailed description
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.
- Conditions
- Pain, Chronic, Knee Pain Chronic
- Being tested
- Pain reprocessing therapy (PRT), Usual care
- Keywords
- chronic pain, Pain Reprocessing Therapy, knee pain, total knee replacement, Total Knee Arthroplasty, mind-body, mindfulness, TKA, PRT
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain reprocessing therapy (PRT)Behavioural
A promising new psychotherapy for chronic pain.
Usual careOther
Also called Treatment as usual
Participants will be asked to continue to do whatever they are currently doing to manage their pain.
| Study group | Role | What they receive |
|---|---|---|
| Pain reprocessing therapy (PRT) | Experimental | 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. Receives: Behavioral: Pain reprocessing therapy (PRT) |
| Usual Care | Other | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 12, 18, and 26 weeks post-randomization
Secondary outcomes (5)
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.
Measured: Approximately 12, 18, and 26 weeks post-randomization
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).
Measured: Approximately 12, 18, and 26 weeks post-randomization
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).
Measured: Approximately 12, 18, and 26 weeks post-randomization
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).
Measured: Approximately 12, 18, and 26 weeks post-randomization
Opioid Use
Opioid Use is assessed via patient-reported medication logs
Measured: Approximately 12, 18, and 26 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start13 Aug 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York, University of Colorado, Denver, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800209
- Sponsor's protocol ID
- 24-2140
- Other IDs
- P30AG022845, 24-2140
- Acronym
- REJOICE
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified project data publicly under Data Use Agreements that safeguard individual participant confidentiality and privacy. The study will produce the following types of data. All data will be available for sharing, except where noted, upon the date of the online publication of the results of the primary study aims: * Patient-reported outcomes: All patient-reported outcomes will be de-identified and shared in raw form. * Measures of treatment engagement: De-identified values (e.g., number of treatment sessions attended) will be shared in raw form. * EEG patient-level summary statistics (de-identified).
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Pain Reprocessing Therapy in Chronic Post-Operative Knee Pain
- ClinicalTrials.gov ID
- NCT06800209
- Acronym / sponsor ID
- REJOICE / 24-2140
- Conditions
- Pain, Chronic, Knee Pain Chronic
- Keywords
- chronic pain, Pain Reprocessing Therapy, knee pain, total knee replacement, Total Knee Arthroplasty, mind-body, mindfulness, TKA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York, University of Colorado, Denver, National Institute on Aging (NIA)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does PRT help lower pain in people who have chronic knee pain after knee surgery?
- How do the effects of PRT compare with usual care in terms of pain relief and other factors such as anxiety, depression, and sleep?
- How does PRT impact the brain?
Participants will:
- Be randomly assigned to receive either PRT or usual care.
- Complete questionnaires about their pain and health.
- If in the PRT group, have eight weekly therapy sessions over video calls with a therapist.
- If interested, may also take part in an optional EEG test to measure brain activity related to pain.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pain reprocessing therapy (PRT) | Experimental | Behavioral: 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. |
| Usual Care | Other | Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
- Active, current psychosis or mania.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain reprocessing therapy (PRT)A promising new psychotherapy for chronic pain. | Behavioural | Pain reprocessing therapy (PRT) |
| Usual careAlso: Treatment as usualParticipants will be asked to continue to do whatever they are currently doing to manage their pain. | Other | Usual Care |
Primary outcome
Pain intensity
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.
5 secondary outcomes
Pain interference
Time frame: Approximately 12, 18, and 26 weeks post-randomization
Depression
Time frame: Approximately 12, 18, and 26 weeks post-randomization
Anxiety
Time frame: Approximately 12, 18, and 26 weeks post-randomization
Fatigue
Time frame: Approximately 12, 18, and 26 weeks post-randomization
Opioid Use
Time frame: Approximately 12, 18, and 26 weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified project data publicly under Data Use Agreements that safeguard individual participant confidentiality and privacy. The study will produce the following types of data. All data will be available for sharing, except where noted, upon the date of the online publication of the results of the primary study aims: * Patient-reported outcomes: All patient-reported outcomes will be de-identified and shared in raw form. * Measures of treatment engagement: De-identified values (e.g., number of treatment sessions attended) will be shared in raw form. * EEG patient-level summary statistics (de-identified).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pain reprocessing therapy (PRT) in people with Pain, Chronic and Knee Pain Chronic, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allina Nocon, PhD (212-774-2572, Complexjoint@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Approximately 12, 18, and 26 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.