Back PainNCT04538430
Peripheral Nerve Stimulation for Back
A study testing SPRINT percutaneous peripheral nerve stimulator placed in people with Back Pain, run by University of Utah at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- SPRINT percutaneous peripheral nerve stimulator placed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 9 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years of age at day of enrollment.
- Clinical diagnosis of refractory low back pain for >3 months.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs at one or two levels.
- Back pain of at least 4/10 or higher using the Numerical Rating Scale (NRS).
- Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.
Who cannot join
- Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
- Contraindications to medial branch targeted PNS (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
- More than 2 levels of clinical proven pain.
- Active moderate to severe lumbar radiculopathy.
- Intradural disc herniation.
- Spinal fracture of posterior elements within the past 6 months.
Show all 22Show fewer
- Steroid injection in the spine within the last 30 days.
- Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.
- Prior fusion at level considered to be the source of the pain.
- Prior lumbar spine surgery within the last 6 months.
- AP diameter of spinal canal less than or equal to 9mm at level to be treated.
- Severe uncontrolled medical condition.
- Severe psychological illness.
- History of Inflammatory arthritis.
- Malignancy within past 5 years except basal cell or squamous cell skin cancer.
- Current use of equal to greater than 45mg morphine-equivalent per day of opioid use.
- A history of alcohol or drug abuse within past 5 years.
- Use of any investigational drug within past 30 days.
- Severe anaphylactic/anaphylactoid reaction to any medications used.
- Pending litigation involving subject's back pain.
- No insurance coverage for any subsequent tests or procedures.
- Inability or unwillingness to continue rehabilitation protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Medial Branch Peripheral Nerve Stimulation for Refractory Axial Back Pain
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.
Read the detailed description
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.
- Conditions
- Back Pain
- Being tested
- SPRINT percutaneous peripheral nerve stimulator placed
- Keywords
- Axial Low Back Pain, Peripheral Nerve Stimulation, Medial Branches
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRINT percutaneous peripheral nerve stimulator placedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Axial Low Back Pain | Other | 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. Receives: Device: SPRINT percutaneous peripheral nerve stimulator placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start22 Nov 2019
- Primary completion15 May 2021
- Study completion9 Sep 2021
Why it stopped: Due to COVID-19 and other factors this study was terminated early and the patients currently enrolled are being used as a small pilot study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zack McCormick, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538430
- Sponsor's protocol ID
- IRB 127414
- Status last verified
- Dec 2022
- First submitted
- 28 Aug 2020
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Branch Peripheral Nerve Stimulation for Refractory Axial Back Pain
- ClinicalTrials.gov ID
- NCT04538430
- Acronym / sponsor ID
- IRB 127414
- Conditions
- Back Pain
- Keywords
- Axial Low Back Pain, Peripheral Nerve Stimulation, Medial Branches
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 and other factors this study was terminated early and the patients currently enrolled are being used as a small pilot study.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 23 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axial Low Back Pain | Other | Device: SPRINT percutaneous peripheral nerve stimulator placedPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years of age at day of enrollment.
- Clinical diagnosis of refractory low back pain for >3 months.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs at one or two levels.
- Back pain of at least 4/10 or higher using the Numerical Rating Scale (NRS).
- Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.
Key exclusion criteria (22 listed)
- Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
- Contraindications to medial branch targeted PNS (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
- More than 2 levels of clinical proven pain.
- Active moderate to severe lumbar radiculopathy.
- Intradural disc herniation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPRINT percutaneous peripheral nerve stimulator placedPlacement 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. | Device | Axial Low Back Pain |
Primary outcome
Pain Numeric Rating Scale (NRS) Response From SPRINT Percutaneous Peripheral Nerve Stimulator
Time frame: 2 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPRINT percutaneous peripheral nerve stimulator placed in people with Back Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numeric Rating Scale (NRS) Response From SPRINT Percutaneous Peripheral Nerve Stimulator (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.