Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Oct 25, 2019

Keywords

ClinConnect Summary

This clinical trial is focused on finding the most effective ways to treat chronic low back pain (cLBP) in Veterans. Many Veterans experience cLBP, which can significantly interfere with daily activities. The study will compare different treatment approaches, including online pain management programs, enhanced physical therapy that combines education with exercise, and other therapies like yoga and cognitive behavioral therapy. The goal is to see which treatment helps reduce pain and improve daily functioning the most over a three-month period.

To participate, Veterans need to have low back pain that has lasted for at least six months and affects their daily life. They must be 18 years or older, able to attend in-person sessions, and have stable internet access. Participants will first try one of the initial treatments and, if they still need help after that, they may be randomly assigned to one of the additional therapies. Throughout the study, they will be monitored for a year to see how well the treatments work over time. If you're a Veteran dealing with chronic low back pain, this study could offer you a chance to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible to participate in this study, an individual must meet all the following criteria:
• • 1. Low back pain
• • 1. present for at least 6 months,
• • 2. present most days or everyday,
• • 3. interferes the most with activities considering all of the places where the patient experiences pain;
• • 2. Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
• • 3. Veteran age 18 years or older, either sex, any racial or ethnic background;
• • 4. Able to comprehend and willing to sign the study informed consent form;
• • 5. Able to attend in-person treatment sessions;
• • 6. Anticipate continuing care at the enrolling VA for the period of the study;
• • 7. Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.
• Exclusion Criteria:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Currently enrolled in any other interventional study unless exempted by CSP;
• • 2. Acute or chronic illness that would prevent the Veteran from receiving study treatments offered (e.g., uncontrolled hypertension, recent myocardial infarction within the last 6 months, unstable angina, acute congestive heart failure);
• • 3. Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
• • 4. Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
• • 5. Current severe alcohol or substance abuse use disorder;
• • 6. Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
• • 7. Undergoing evaluation for back surgery or planned back surgery;
• • 8. Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;
• • 9. Pregnancy;
• • 10. Refusal to provide written consent.