An interventional study of SPRINT percutaneous peripheral nerve stimulator placed in Back Pain, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
To assess changes in pain, physical function, health-related quality of life, and cost-effectiveness in patients with low back pain, without symptoms of radiculopathy, that have not responded to conservative or traditional interventional measures and are having a SPRINT percutaneous peripheral nerve stimulator placed as standard of care. Patients will be assessed periodically (by questionnaire) after the placement of the SPRINT, FDA approved 60 day, percutaneous peripheral nerve stimulator, targeting the bilateral medial branches at the suspected level of pain generation. Neither the manufacturer nor the FDA are involved or will have access to data from this study.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Assessment of Pain Numeric Rating Scale (0-10) response after placement of SPRINT percutaneous peripheral nerve stimulator for chronic low back pain. 0 being no pain and 10 being the worst pain.
Time frame: 2 months
| Milestone | Axial Low Back Pain |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
Assessment of Pain Numeric Rating Scale (0-10) response after placement of SPRINT percutaneous peripheral nerve stimulator for chronic low back pain. 0 being no pain and 10 being the worst pain.
| score on a scale | Axial Low Back Pain |
|---|---|
| Pain Numeric Rating Scale (NRS) Response From SPRINT Percutaneous Peripheral Nerve Stimulator | 3.17 (0 to 10) |
Collected over up to 21 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Axial Low Back Pain | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Axial Low Back Pain |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 6 |
| Sex: Female, Male(Participants) | Axial Low Back Pain |
|---|---|
| Female | 3 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Axial Low Back Pain |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
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