๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to learn which treatment works better for veterans with chronic neck or back pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain).
The main questions the study aims to answer are:
1. Which treatment works better for lowering pain: PRT, CBT, or usual care?
2. How do the effects of PRT compare with CBT and usual care in terms of pain relief and other factors such as emotional functioning, quality of life, anxiety, and pain medication use?
Participants will:
1. Be randomly assigned to receive either PRT, CBT, or usual care.
2. Complete questionnaires about their pain and health.
3. If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Adults (18 and older)
* Be veterans
* Have a history of chronic back or neck pain defined as pain at least half the days of the last 6 months.
* Have moderate or greater pain, defined as pain intensity โฅ4 in the past week
Exclusion Criteria:
Clinical presentation suggestive of back pain that is secondary or peripheral in nature, including self-reported leg pain that is worse than back pain (indicative of radiculopathy or sciatica), spine surgery within the past 6 months, fall, motor vehicle accident or other trauma related to back pain in the past 6 months, back pain due to an inflammatory disorder, infection, or malignant etiology as determined per medical provider review, known sensory abnormality in trunk or legs, recent large (\>20 lbs) unexplained weight loss, difficulty controlling bowels (to screen out cauda equina syndrome), and self-reported diagnoses of specific inflammatory disorders (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, and polymyositis).
Additionally, patients who meet any of the following criteria are ineligible due to anticipated difficulties complying with study procedures:
* Moderate or severe cognitive impairment
* Unstable or severe untreated mental health condition, including active suicidal ideation
* Unstable or end-stage medical disease including active cancer
* Back surgery planned within the next 6 months
* Inability to communicate by telephone or video, including inability due to housing instability
* Current pain-related litigation outside the VA (service connection-related applications are not excluded)
* Having engaged in CBT or PRT for chronic pain in the past 6 months
* Participants may be excluded based on the discretion of PIs Ashar and Frank
๐
What it tests
- Pain reprocessing therapy (PRT)
- Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
- Usual Care
VA Eastern Colorado Health Care System
Aurora, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.