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Behavioral Intervention

Pain Reprocessing Therapy for Chronic Knee Pain (REJOICE Trial)

Aurora, CO

N/A

Waitlist Available

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Major surgery or other major medical event planned in the coming 6 months

Self-reported diagnosis of an autoimmune disease: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, polymyositis, or other autoimmune disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12, 18, and 26 weeks post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if Pain Reprocessing Therapy (PRT) can help adults with knee pain after knee replacement surgery compared to regular care. The study will look at whether PRT can reduce chronic

Who is the study for?

This trial is for adults with chronic knee pain after knee replacement surgery. Participants will be randomly assigned to receive either Pain Reprocessing Therapy (PRT) or usual post-surgery care and must be willing to complete questionnaires and possibly undergo an EEG test.

What is being tested?

The study aims to determine if PRT can reduce chronic knee pain more effectively than the usual care following knee surgery. It involves eight weekly therapy sessions via video calls and measures outcomes like pain relief, anxiety, depression, sleep quality, and brain activity related to pain.

What are the potential side effects?

Since PRT is a psychological therapy involving no medication or invasive procedures, side effects are minimal but may include temporary increases in emotional distress due to discussing painful experiences.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major surgeries or medical events planned in the next 6 months.

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I have been diagnosed with an autoimmune disease like rheumatoid arthritis or Lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12, 18, and 26 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12, 18, and 26 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12, 18, and 26 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain intensity

Secondary study objectives

Anxiety

Depression

Fatigue

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 Intervention

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 mean completion time of the PRT arm, and may be adjusted at mid-enrollment to match treatment arm length more closely.

Group II: Pain reprocessing therapy (PRT)Experimental Treatment1 Intervention

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 one assessment and education telehealth session with a physician followed by 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.

0 / 2Eligibility criteria met