Comparing two implanted pain relief devices for chronic back pain

Plain-English translation of NCT07091123 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated September 2026 · How we translate trials

What is this trial?

This trial compares two implanted devices designed to relieve chronic back pain in people who haven't found relief through other treatments. One device, called spinal cord stimulation, works by sending electrical pulses to reduce pain signals. The other, called an intrathecal drug delivery system (or pain pump), delivers pain medication directly into the fluid around your spine. The study lets you try both treatments as temporary tests before deciding which one—if either—to have surgically implanted permanently.

Doctors know both of these devices can help some people with severe back pain, but there's no clear evidence about which treatment works better for individual patients. This study exists to let patients safely test both options and choose based on their own experience, rather than guessing which device might help them most.

Do you qualify?

You likely qualify if…

you are at least 30 years old
you have had spine surgery in the past on your lower or mid-back
your back pain is severe and mostly in your back (not your legs), and hasn't improved with physical therapy, medications, or steroid injections
you have passed a psychological evaluation and are stable on your current pain medications
you are willing to temporarily reduce strong opioid pain medications if needed before the trial begins

You likely don't qualify if…

you are pregnant
you are taking more than 15 mg per day of morphine-equivalent opioids and cannot reduce this amount
you have an active infection or a bleeding disorder, or take blood-thinning medications you cannot safely stop
you have a weakened immune system that would make implanted devices risky for you
you are allergic to bupivacaine or fentanyl (the medications used in the pain pump test)

What participation looks like

You will have two separate trial periods—one testing each device—spaced about 2 to 4 weeks apart. In each trial, a temporary device is placed using a needle procedure, and you'll wear it for 8 to 23 hours while going about your day. After both trials are complete, you'll visit the clinic to fill out questionnaires describing which treatment relieved your pain better. If either treatment reduces your pain by at least 50%, you can choose to have that device surgically implanted as a permanent solution. If neither helps enough, the study ends without any implant. The study's formal data collection finishes after these trials and questionnaires; any follow-up care after an implant would be regular clinic visits as normal.

Comparing two implanted pain relief devices for chronic back pain

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)