Pain Reprocessing Therapy for persistent knee pain after knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic pre-operative knee pain who continue to have pain three months after a primary knee replacement are randomized to eight weekly telehealth PRT sessions or to usual post-operative care. Participants complete questionnaires on pain intensity, function, anxiety, depression, and sleep, and a subset may undergo optional EEG to measure brain activity related to pain. The PRT intervention uses cognitive, exposure-based, and somatic techniques to help patients reconceptualize pain as reversible brain-driven activity rather than ongoing tissue damage. Outcomes and mediation analyses will measure clinical effects at post-treatment and over longitudinal follow-up and test psychological and neurobiological mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Where it's running

• Hospital for Special Surgery
  New York, New York, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Active not recruiting

Study contacts

• Principal investigator: Cary Reid, MD, PhD — Weill Medical College of Cornell University
• Study coordinator: Allina Nocon, PhD
• Email: Complexjoint@hss.edu
• Phone: 212-774-2572

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.