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Chronic Low Back Pain Research Study
Study OverviewThe RESET study is comparing the SPRINT® Peripheral Nerve Stimulation (PNS) System to standard of care treatments for chronic low back pain to determine if SPRINT PNS can reduce your low back pain, improve function, and reduce the need for pain medications.
What is the SPRINT® Peripheral Nerve Stimulation (PNS) System?The SPRINT Peripheral Nerve Stimulation (PNS) System is an FDA-cleared, medication-free pain management option that has been studied extensively for low back pain, shoulder pain, post-amputation pain, and post-operative pain. The SPRINT PNS System uses two small leads made of very fine wire (about twice the size as a human hair) which are placed into your back by a doctor in a simple outpatient procedure. The leads are connected to a small, wearable device that delivers mild electrical pulses directly to nerves in the back for 60 days. You control the level of stimulation to your comfort level with a hand-held remote. The stimulating leads are removed at the end of the 60-day treatment, which may provide significant long-term pain relief. SPRINT PNS does not involve permanent implants and allows you to maintain most of your routine activities without worrying about side effects like nerve destruction or addiction to pain medication. It is a low-risk alternative to more invasive or irreversible treatments such as ablation, permanent implants, or surgery.
What to Expect
If you decide to participate, and this study is a good fit for you, you will be randomly assigned to one of two groups. Half the study participants will receive SPRINT PNS. The other half will initially receive standard of care treatment, with an option to receive SPRINT PNS after 12 months.
If you are in the group that receives SPRINT PNS, you will have a minor procedure to place the SPRINT PNS leads. The SPRINT PNS System will be left in place for up to 60 days, after which the leads will be removed in the doctor’s office.
All study-related procedures and SPRINT PNS will be provided at no cost to you. You will be paid a small amount for your time and completing study visits. You may also be eligible for study-related travel reimbursement.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
- Experienced low back pain for more than 6 months
- Additional low back pain screening criteria
- 21 to 75 years old
- Female or Male
CONTACT THE RESEARCH TEAM TO LEARN MORE ABOUT THIS STUDY