Pain Reprocessing Therapy in Post-Operative Knee Pain

NCT06800209 | Recruiting Phase 2 DMC

• 1 other identifier: 24-2140
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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. The main questions the study aims to answer are:

1. 1.Does PRT help lower pain in people who have chronic knee pain after knee surgery?
2. 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. 3.How does PRT impact the brain?
4. 4.Be randomly assigned to receive either PRT or usual care.
5. 5.Complete questionnaires about their pain and health.
6. 6.If in the PRT group, have eight weekly therapy sessions over video calls with a therapist.
7. 7.If interested, may also take part in an optional EEG test to measure brain activity related to pain.

Conditions

Pain, Chronic; Knee Pain Chronic

Keywords

chronic pain; Pain Reprocessing Therapy; knee pain; total knee replacement; Total Knee Arthroplasty; mind-body; mindfulness; TKA; PRT

Outcome Measures

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.

  Approximately 12, 18, and 26 weeks post-randomization

Secondary Outcomes (5)

• Pain interference

  Approximately 12, 18, and 26 weeks post-randomization

• Depression

  Approximately 12, 18, and 26 weeks post-randomization

• Anxiety

  Approximately 12, 18, and 26 weeks post-randomization

• Fatigue

  Approximately 12, 18, and 26 weeks post-randomization

• Opioid Use

  Approximately 12, 18, and 26 weeks post-randomization

Study Arms (2)

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.

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.

Other: Usual care

Interventions

Pain reprocessing therapy (PRT) BEHAVIORAL

A promising new psychotherapy for chronic pain.

Pain reprocessing therapy (PRT)

Usual care OTHER

Participants will be asked to continue to do whatever they are currently doing to manage their pain.

Also known as: Treatment as usual

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.
• Are unable or uncomfortable with completing a dry cap EEG.
• Has had a history of abnormal EEGs.
• Had bilateral TKA

Sponsors & Collaborators

• Hospital for Special Surgery, New York: collaborator
• University of Colorado, Denver: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Allina Nocon, PhD

CONTACT

212-774-2572; Complexjoint@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be completed via automated transmission of a REDCap link, and as such is inherently blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 29, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Complete, clean, de-identified copies of the data components described above, along with data dictionaries and metadata, will be publicly posted along with data use agreements by the online publication date of the primary aims in a peer-reviewed journal.
• Access Criteria: Data Use Agreements will ask users to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants. Investigators will consult, as needed, with Cornell Data Services (CDS), formerly known as Cornell Research Data Management Service Group (RDMSG). As described in the Cornell Roybal Center's overall data-sharing plan, through the Cornell Roybal Center Investigator Development Program, investigators will have access to instruction and assistance to address requests for information that ensure research transparency and reproducibility: documentation on study aims; hypotheses/research questions; variable sources (e.g., outcome variables, covariates); measure/index construction; and publication information.

Locations

US (2)