Back PainNCT03179202

Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System in people with Back Pain and Low Back Pain, run by SPR Therapeutics, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Back Pain, Low Back Pain
What is being tested?: SPRINT Peripheral Nerve Stimulation (PNS) System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 8 sitesUnited States
Study dates: 23 Jun 2017to 11 May 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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 21 years of age
Chronic low back pain

Who cannot join

Infection on or around the low back
Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
Implanted electronic device
Body Mass Index (BMI) > 40
Pregnant

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

The Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia, 25301
Duke University Medical Center
Durham, North Carolina, 27710
Hope Research Institute
Peoria, Arizona, 85381
Virginia iSpine Physicians
Richmond, Virginia, 23235
Premier Pain Centers
Shrewsbury, New Jersey, 07702
Integrated Pain Management Medical Group
Walnut Creek, California, 94598
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, 20006
Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).

Conditions: Back Pain, Low Back Pain
Being tested: SPRINT Peripheral Nerve Stimulation (PNS) System
Keywords: Electrical Stimulation, Neurostimulation, Neuromodulation, Back Pain, Low Back Pain
Medical subject headings: Back Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPRINT Peripheral Nerve Stimulation (PNS) SystemDevice
Also called SPRINT System, Smartpatch System, SPRINT, Smartpatch
The SPRINT PNS System is a device which delivers mild electrical stimulation to the muscles in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain.

Study groups in NCT03179202
Study group	Role	What they receive
Peripheral Nerve Stimulation	Experimental	All study subjects will have up to 4 Leads placed in their low back, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation. Receives: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
All subjects were asked to complete daily diaries to record their average pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 5 (BPI-5). The BPI-5 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated and percent reduction was determined. Subjects that achieved ≥30% reduction in pain, were considered successful.
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Number of Subjects That Experienced at Least One Study-Related Adverse Event
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Measured: Up to 15 months for each subject from baseline to the last study visit

Secondary outcomes (6)

Worst Pain Intensity
All subjects were asked to complete daily diaries to record their worst pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 3 (BPI-3). The BPI-3 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated. The mean score across all subjects for each time point is reported.
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a widely used assessment designed to measure the degree of disability in people with low back pain. This validated questionnaire includes topics concerning the intensity of pain, the subject's ability to perform normal daily activities such as personal care, walking, sitting, or standing, and how pain affects the subject's sex life, social life, and travel. The scale ranges from 0-100 and higher scores indicate greater disability due to low back pain. The mean score across all subjects at baseline and end of treatment (EOT) is reported here.
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Mean Change in Health-Related Quality of Life
The RAND 36-Item Short Form Health Survey is a widely accepted form used to quantify quality of life. The survey consists of 8 categories with a total of 36 questions regarding the subject's general health and activities. The survey assesses physical and emotional problems associated with pain during the past 4 weeks. Each category is scored on a 0-100 scale, where a higher score indicates a more favorable health state. The score for each category was calculated at baseline and End of Treatment (EOT) for each subject. The change in each category score from Baseline to EOT was then calculated for each subject (with a positive change indicating an increase in health-related quality of life). The mean and standard deviation of the subjects' changes in each category are presented below.
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory (BDI-II) is a validated, 21-question survey used to measure depression severity. Questions are rated on a scale from 0 to 3, and the scores from each question are totaled to provide an overall score ranging between 0 to 63. Scores from 0-13 indicate minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 indicates severe depression. The average total scores across subjects were calculated at baseline and end of treatment (EOT).
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Patient Global Impression of Change (PGIC) Survey
The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale where 1 represents "very much worse" and 7 represents "very much improved" as compared to before stimulation treatment. The subjects combine all the components of their experience into one overall score. The number of participants with each rating after 8 weeks of treatment is reported here.
Measured: 8-weeks post-Start of Treatment (SOT)
Pain Interference
Question 9 of the Brief Pain Inventory-Short Form (BPI-9) is a 7-part question that assesses the level of interference that subjects experience in their daily lives due to pain. The 7 categories are general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Subjects were asked to rate how much their low back pain interferes with each aspect on an 11-point numerical scale where 0 represents "Does Not Interfere" and 10 represents "Completely Interferes." The average of these 7 scores was calculated for each subject. The mean was taken across subjects for each time point.
Measured: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 201711 May 2021

First posted7 Jun 2017
Study start23 Jun 2017
Primary completion11 May 2021
Study completion11 May 2021

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.
Publications (2)Papers the sponsor has linked to this study.
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: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03179202
Sponsor's protocol ID: 0142-CSP-000
Status last verified: Jul 2022
First submitted: 1 Jun 2017
Last updated: 5 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Gilmore CA, Deer TR, Desai MJ, Li S, DePalma MJ, Cohen SP, Swan BD, McGee MJ, Boggs JW. Four-Year Follow-Up from a Prospective, Multicenter Study of Percutaneous 60-Day Peripheral Nerve Stimulation for Chronic Low Back Pain. Pain Ther. 2025 Jun;14(3):1103-1115. doi: 10.1007/s40122-025-00737-3. Epub 2025 Apr 22.
PubMed 40261580
Deer TR, Gilmore CA, Desai MJ, Li SC, DePalma MJ, Hopkins TJ, Burgher AH, Spinner DA, Cohen SP, McGee MJ, Boggs JW. Percutaneous Peripheral Nerve Stimulation of the Medial Branch Nerves for the Treatment of Chronic Axial Back Pain in Patients After Radiofrequency Ablation. Pain Med. 2021 Mar 18;22(3):548-560. doi: 10.1093/pm/pnaa432.
PubMed 33616178

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
ClinicalTrials.gov ID: NCT03179202
Acronym / sponsor ID: 0142-CSP-000
Conditions: Back Pain, Low Back Pain
Keywords: Electrical Stimulation, Neurostimulation, Neuromodulation, Back Pain, Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: SPR Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 23 Jun 2017 (actual)
Primary completion: 11 May 2021 (actual)
Study completion: 11 May 2021 (actual)
First posted: 7 Jun 2017 (actual)
Results: Posted 5 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Peripheral Nerve Stimulation	Experimental	Device: SPRINT Peripheral Nerve Stimulation (PNS) SystemAll study subjects will have up to 4 Leads placed in their low back, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

At least 21 years of age
Chronic low back pain

Key exclusion criteria (5 listed)

Infection on or around the low back
Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
Implanted electronic device
Body Mass Index (BMI) > 40
Pregnant

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 Peripheral Nerve Stimulation (PNS) SystemAlso: SPRINT System, Smartpatch System, SPRINT, SmartpatchThe SPRINT PNS System is a device which delivers mild electrical stimulation to the muscles in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain.	Device	Peripheral Nerve Stimulation

Primary outcome

Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
All subjects were asked to complete daily diaries to record their average pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 5 (BPI-5). The BPI-5 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated and percent reduction was determined. Subjects that achieved ≥30% reduction in pain, were considered successful.
Number of Subjects That Experienced at Least One Study-Related Adverse Event
Time frame: Up to 15 months for each subject from baseline to the last study visit
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.

6 secondary outcomes

Worst Pain Intensity
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Oswestry Disability Index (ODI)
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Mean Change in Health-Related Quality of Life
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Beck Depression Inventory (BDI-II)
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Patient Global Impression of Change (PGIC) Survey
Time frame: 8-weeks post-Start of Treatment (SOT)
Pain Interference
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)

Results and safety

Results posted to the registry on 5 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Consented Subjects	166	75

Primary outcome: Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity

Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment). Count of participants. Unit: Participants

Measure	Protocol Population n = 83
Value	58

Population analysed: Protocol Population presented. EOT data were not available for eight subjects.

Primary outcome: Number of Subjects That Experienced at Least One Study-Related Adverse Event

Time frame: Up to 15 months for each subject from baseline to the last study visit. Count of participants. Unit: Participants

Measure	Enrolled/Received Leads n = 99
Value	49

Population analysed: All enrolled subjects that received leads are presented.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 14 months for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled/Received Leads	4 of 99 (4%)	49 of 99 (49.5%)	1 of 99

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40261580Gilmore CA, Deer TR, Desai MJ, Li S, DePalma MJ, Cohen SP, Swan BD, McGee MJ, Boggs JW. Four-Year Follow-Up from a Prospective, Multicenter Study of Percutaneous 60-Day Peripheral Nerve Stimulation for Chronic Low Back Pain. Pain Ther. 2025 Jun;14(3):1103-1115. doi: 10.1007/s40122-025-00737-3. Epub 2025 Apr 22.
Derived from this study: PubMed 33616178Deer TR, Gilmore CA, Desai MJ, Li SC, DePalma MJ, Hopkins TJ, Burgher AH, Spinner DA, Cohen SP, McGee MJ, Boggs JW. Percutaneous Peripheral Nerve Stimulation of the Medial Branch Nerves for the Treatment of Chronic Axial Back Pain in Patients After Radiofrequency Ablation. Pain Med. 2021 Mar 18;22(3):548-560. doi: 10.1093/pm/pnaa432.
Sponsor's WebsiteLink provided by the sponsor.

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

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.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System in people with Back Pain and Low Back Pain, run by SPR Therapeutics, Inc. at 8 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 5 Aug 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?

Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity (time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179202, which also lists 2 linked publications.

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 5 Aug 2022.