Why Participate?
Clinical research is an important step in the development of any new treatment. Research studies can help advance our understanding of how new or FDA-cleared treatments work in people with medical conditions.
There is no guarantee that participating in the RESET study will improve your low back pain. However, by choosing to participate in this study, you are contributing to research that may improve our understanding of chronic low back pain and lead to better treatment options for people in the future.
About the Study
The 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. Up to 230 participants will be enrolled at about 30 study sites in the United States.
To learn more about the RESET study, click on the video below.
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.
The SPRINT 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.
To learn more about how the SPRINT PNS system works, click on the video below.
FAQs
Is the SPRINT PNS System FDA-cleared?
Yes, the SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
- Symptomatic relief of post-traumatic pain
- Symptomatic relief of post-operative pain
The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.
What is the purpose of the RESET study?
To compare the SPRINT® Peripheral Nerve Stimulation (PNS) System to standard of care treatments for low back pain and determine if SPRINT PNS can reduce your chronic low back pain, improve function, and reduce the need for pain medications.
How long will the RESET study last?
You will be enrolled in the study for about 2 years and 2 months.
Does it cost anything to participate?
No, all study-related procedures and SPRINT PNS will be provided at no cost to you. Additionally, you may be eligible for compensation for completing study visits and reimbursement for study-related travel expenses. Please ask your study team for more information.
What if this study is not a good fit for me?
You can choose to leave the study at any time, for any reason. Choosing to not participate in this study will not affect your future medical care.
Am I guaranteed to receive treatment for my chronic low back pain as part of the RESET study?
Yes. Half the study participants will be randomly assigned to initially receive treatment with the SPRINT PNS System. The other half will initially receive appropriate standard of care treatment, which could include injections, radiofrequency ablation (RFA), spinal cord stimulation (SCS), surgery, or other treatments recommended by their doctor. Participants who were not initially assigned to receive SPRINT PNS may be eligible to receive SPRINT PNS after one year.
Where are the leads implanted?
The leads will be placed near nerves in the area of your low back pain.
What does stimulation feel like?
Stimulation may feel different for everyone, but most people report that SPRINT PNS creates comfortable massaging, tingling, or pulsing sensations in the low back that may reduce pain and the need for pain medications.
What are the possible side effects?
All treatments and research studies come with some risks. The most common side effects of the SPRINT PNS System are skin irritation and erythema (redness), which usually go away within a few days. The study staff will review all of the potential benefits and risks with you and answer any questions you may have.
Are there any restrictions while using SPRINT PNS?
You can go about most of your normal activities while using SPRINT PNS. Before taking a shower, you will need to disconnect the pulse generator. Bathing and swimming must be avoided.
Can I continue taking pain medications?
You may continue taking pain medications (opioid or non-opioid) that your healthcare provider has prescribed or recommended.
What happens after the leads are removed at the end of the 60-day treatment?
Most people have reported significant pain relief for up to 1 year after treatment with SPRINT PNS. You will be asked to periodically rate the intensity of your chronic low back pain for up to 2 years after treatment. You will also be asked to attend 6 follow up visits with the study team during this time.
