Pain Reprocessing Therapy in Post-Operative Knee Pain

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Pain Reprocessing Therapy (PRT) to see if it can help adults with ongoing knee pain after they have had knee replacement surgery. The study compares PRT to the usual care that people typically receive after their surgery to find out which method is more effective at reducing pain and improving overall well-being, including feelings of anxiety and depression, as well as sleep quality.

To participate, you need to be at least three months post-surgery, have had a successful knee replacement, and still be experiencing noticeable pain. If you join the trial, you'll be randomly assigned to either receive PRT—which involves eight weekly therapy sessions over video calls with a therapist—or the usual care. You'll also fill out surveys about your pain and health. Additionally, if you're interested, you can take part in an optional brain test (EEG) that looks at how your brain responds to pain. This study is currently recruiting participants, and it’s open to all genders aged 65 to 74.

Gender

ALL

Eligibility criteria

• 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 10 on Numeric Rating Scale (NRS).
• • 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.
• • Major surgery for lower extremity or spine within 1 year of the current primary TKA.
• • 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.