Evaluating pain treatment effectiveness for veterans with chronic low back pain

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

This study focuses on veterans suffering from chronic low back pain (cLBP) and aims to identify the most effective non-surgical and non-pharmacological treatment options. It employs a sequential randomized, pragmatic, 2-step comparative effectiveness design, where the first step compares continued care and active monitoring to internet-based pain self-management and an enhanced physical therapy intervention. Those who do not experience significant pain relief in the first step will be randomized in the second step to receive either yoga, spinal manipulation therapy, or cognitive behavioral therapy. The study is designed to address the high prevalence and impact of cLBP among veterans, particularly in light of the opioid crisis.

Why it matters

Who can join: the full rules

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 and willing 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. Back surgery within the last 6 months, or 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

Where it's running

• Phoenix VA Health Care System, Phoenix, AZ
  Phoenix, Arizona, United States Recruiting
• VA Loma Linda Healthcare System, Loma Linda, CA
  Loma Linda, California, United States Recruiting
• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• Orlando VA Healthcare System, Orlando, FL
  Orlando, Florida, United States Recruiting
• Atlanta VA Medical and Rehab Center, Decatur, GA
  Decatur, Georgia, United States Recruiting

Study contacts

• Study coordinator: Brandon J Stevenson, MSW BS
• Email: Brandon.Stevenson@va.gov
• Phone: (319) 388-0581

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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.