Back Pain Study

Information for Patients

What is Chronic Low Back Pain?

Chronic low back pain is defined as pain that lasts more than 3 months.  The pain is located in the low back and can worsen with bending, sitting, or even turning over in bed.  Sneezing or coughing can sometimes make the pain worse.  Occasionally, the pain can radiate to the buttocks or down a leg.

What Causes Low Back Pain?

There are many causes of low back pain and it can be due to strain of the muscles or ligaments of the back or injury to the bones or discs that comprise the spine. Often, we are unable to determine an exact event or injury responsible for chronic low back pain. 

What Treatments Are Available for Chronic Low Back Pain?

Chronic back pain is a very common medical problem.  Unfortunately, there are not many effective treatments for chronic low back pain (e.g. lasting more than 3 months).  Sometimes the pain will improve on its own.  Drug therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) are common. Another common treatment for moderate to severe chronic back pain is the use of opioid pain medications. However, opioid physical dependency is a potential side effect of extended opioid use. Our study aims to reduce these side effects with a complementary medication called Ondansetron.

What Can I Expect if I Choose to Participate in the Stanford Back Pain Study?

To determine your eligibility for the study, you will be given two cost-free medical screenings. The preliminary screening will be scheduled with our trained research assistants (RAs). If you are deemed eligible by our RAs, a second eligibility examination will be scheduled with our principal investigator, Dr. Larry Chu, MD, MS, Assistant Professor of Anesthesia at the Stanford University School of Medicine and Palo Alto Veterans Affairs Hospital. The purpose of these examinations is to gather additional information regarding your past medical history and to perform a physical examination to ensure that you do not have any serious back problems that might require other more immediate interventions.

If eligible, your first study date will consist of baseline questionnaires and tests, including a blood draw. After we finish testing, you will receive the study medications including the opioid pain medicine (MS Contin) and possibly Ondansetron. Instructions for this 30-day medication trial will be provided. Your second and final study date will include testing to measure whether Ondansetron can prevent physical dependency on opioid medications.

Will I be Paid to Participate in this Study?

The study is being sponsored by the National Institutes of Health. You will be paid $500 for your participation in this 5-week study.

I've Heard that Opioid Medicines such as Morphine are Addictive. Will I become Addicted to Morphine if I Participate in This Study?

While it is true that opioid medications have some potential for abuse, it is very unlikely that you will become addicted during this study for several reasons. First, the length of the study is limited to 5 weeks, after which you will be tapered off of the study medication. It is unlikely that you will become addicted during this short period of time when you will be closely monitored by a physician. Second, addiction is very unlikely if you do not have a history of addiction or substance abuse.

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