Clinical Trials

The effectiveness of Boston Scientific pain management solutions have been proven in a number of important clinical trials. Below you can find information about upcoming clinical trials focused on pain management.

The ENLITEN Study

No one understands chronic pain better than those who live with it every day.  Boston Scientific is conducting the ENLITEN Study to help raise our understanding of what chronic pain is REALLY like for people like you.

In the ENLITEN Study you will use a mobile app to answer questions about your pain, how it impacts your daily life, and how the different types of therapy you’re using to treat it are working.

To participate in the study, you must be:

22 years of age or older
Planning to receive or already using a commercially approved, interventional medical device therapy/procedure (e.g., a Spinal Cord Stimulator (SCS) system, or the Vertiflex^™Procedure^†) to treat your chronic pain
A current resident of the United States or District of Columbia
Comfortable reading, writing, and speaking English

You must also have a smartphone compatible with the study app and a valid email address.

If you would like to participate in the ENLITEN study, start by downloading the myStudyPartner+ Clinical Study App from your device’s app store. You can also scan this QR code with your smartphone camera to get the app.

Once you open the app, you will be asked to Allow Paste from Messages. Either Allow Paste or simply enter the ENLITEN study code, which is 124020266. You will then be prompted to answer a few questions to see if you are a candidate to participate in the study. If you are, you will receive an email with a consent form and instructions on how to begin your participation in the study.

The FAST™ Study

Chronic pain affects 1 in 5 adults, and can impact nearly every aspect of daily life - from work performance, to family life, to social interactions.¹ For many people, this pain affects the lower back and/or legs, and can be caused by a variety of underlying conditions.

If you’ve struggled with chronic low back and/or leg pain for at least 6 months that has not responded to other treatments, you may be a candidate for the FAST Study. The study uses the WaveWriter™ Spinal Cord Stimulator System - an FDA-approved, drug-free therapy shown to effectively relieve chronic pain and improve quality of life.^2,3

Explore the FAST Study

The SCOPE Study

If you’ve been living with dull or aching leg pain, numbness or cramping (with or without back pain), you may have lumbar spinal stenosis (LSS) - and you have options. One option is the Vertiflex^™ Procedure^†, a minimally-invasive medical solution that can help treat the root cause of LSS. The Vertiflex Procedure offers a safe and effective alternative to more invasive surgical options, with most people returning home the same day they receive the Vertiflex Procedure.

The Vertiflex Procedure is currently being offered at select US centers through a new clinical research study called the SCOPE Study. If you qualify and choose to join the SCOPE Study you will be treated by a local physician specialist, and will be compensated for your time and travel for attending follow-up visits to evaluate your progress.

Explore the SCOPE Study

^†Superion™ Indirect Decompression System.

References: 1. Dahlhamer J, Lucas J, Zelaya, C, et al. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults — United States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:1001–1006. 2. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS—LUMINA Study. Pain Med. 2017;18(8):1534-1548. 3. Thomson SJ, Kruglov D, Duarte RV. A spinal cord stimulation service review from a single centre using a single manufacturer over a 7.5 year follow-up period. Neuromodulation. 2017;20(6):589-599. N=321

Indications for Use. The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries.

Contraindications. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant.

Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.

Boston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.

Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For therapy that does not generate paresthesia (i.e. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. Contraindications, warnings, precautions, side effects. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level, scoliosis or spinous process fractures, osteoporosis, infection, allergy or reaction to any metal or implant or a high Body Mass Index. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Indications for Use: The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.

Warnings: The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. For appropriate guidance, consult the instructions for use for these active devices. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.