Peripheral Nerve Stimulation for Back
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|ClinicalTrials.gov Identifier: NCT04538430|
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Device: SPRINT percutaneous peripheral nerve stimulator placed||Not Applicable|
Low back pain is one of a few conditions which affects all individuals through the lifespan. The etiology of low back pain is multifactorial and in many cases self-limiting, however it also is the leading cause for working age adults to be disabled with more than $87 billion spent on low back pain disorders in 2013. Listhesis of a vertebral body, chronic compression fractures, lumbar disc herniation, and internal disc disruptions are some primary anatomical abnormalities that can cause back pain and do not have great targeted treatments. that may more common in these younger age groups reaching 39-42% with a predicted probability above 60% until age 50y. While the natural history of back pain suggests most individuals will return to a prior level of function in 3-6 months, there is a high rate of recurrent episodes which can cause short-term disability. Continued back pain can lead to decreased activity levels and accelerate degenerative changes in the disc and facet joints as described by Kirkaldy-Willis.
Current guidelines for treatment of axial low back pain include a 6-12-week course of conservative care including medications, therapy, acupuncture, chiropractic and exercise before an interventional paradigm of injections and/or surgical treatment. For those individuals who do not improve with conservative care and have predominately axial pain, options are limited as success rates from epidural steroid injections and surgery are 50% or less. Other treatments include chymopapain injection, intradiscal electrothermal annuloplasty (IDET), nucleoplasty, methylene blue injection. All of which have 50% or less likelihood of reducing pain more than 50%, although much of this data is from uncontrolled or prospective case-control studies only.
Peripheral Nerve Stimulation (PNS) recently gained FDA approval as an interventional treatment of chronic back pain. PNS involves a minimally invasive percutaneous microelectrode connected to an external impulse generator that adheres to the skin for up to 60 days and then the entire system is removed. It is theorized that the neuromodulatory effects of PNS interrupts the chronic pain cycle and allowing healthy recovery of afferent signaling and limiting and perhaps reversing the maladaptive cortical plasticity involved in chronic pain. There have been two prospective cohort studies published this year, both of which showed meaningful clinical improvement in pain and function scores. One of these studies (Cohen et al.) showed that more than 50% of the patients had greater than 50% improvement in pain at one year after undergoing 2 months of implanted PNS treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medial Branch Peripheral Nerve Stimulation for Refractory Axial Back Pain|
|Actual Study Start Date :||November 22, 2019|
|Estimated Primary Completion Date :||November 22, 2024|
|Estimated Study Completion Date :||July 1, 2025|
Axial Low Back Pain
Patient diagnosed with axial low back pain not responding to conservative measures and no symptoms of radiculopathy, that is scheduled to have a SPRINT percutaneous peripheral nerve stimulator placed as standard of care.
Device: SPRINT percutaneous peripheral nerve stimulator placed
Placement of a SPRINT percutaneous peripheral nerve stimulator targeting the bilateral medial branches at the suspected level of pain generation. This procedure is done as standard of care.
- Pain Numeric Rating Scale (NRS) response from SPRINT percutaneous peripheral nerve stimulator [ Time Frame: 5 years ]Assessment of Pain Numeric Rating Scale response after placement of SPRINT percutaneous peripheral nerve stimulator for chronic low back pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538430
|Contact: Shellie S Cunningham, BSemail@example.com|
|Contact: Talmage Morrisfirstname.lastname@example.org|
|United States, Utah|
|University of Utah Orthopaedic Center||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Shellie S Cunningham, BS 801-587-5488 email@example.com|