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Low Back PainNCT04246281

The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System and Standard interventional management of low back pain in people with Low Back Pain and Back Pain, run by SPR Therapeutics, Inc. at 18 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

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Low Back Pain, Back Pain
What is being tested?
SPRINT Peripheral Nerve Stimulation (PNS) System and Standard interventional management of low back pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
18 sitesUnited States
Study dates
17 Jun 2020to 27 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic low back pain

Who cannot join

  • Body Mass Index (BMI) > 40
  • Prior lumbar surgery
  • Implanted electronic device
  • Pregnant

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Emory University

    Atlanta, Georgia, 30329

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Millennium Pain Center

    Bloomington, Illinois, 61704

  • Spine and Nerve Center of St. Francis Hospital

    Charleston, West Virginia, 25301

  • The Ohio State University

    Columbus, Ohio, 43210

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414

  • Duke University

    Durham, North Carolina, 27710

  • Denver Back Pain Specialists

    Greenwood Village, Colorado, 80111

  • Main Line Spine

    King of Prussia, Pennsylvania, 19406

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Northwest Speciality Hospital

    Post Falls, Idaho, 83854

  • Virginia iSpine Physicians

    Richmond, Virginia, 23235

  • Hunter Holmes McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • University of Utah

    Salt Lake City, Utah, 84108

  • Premier Pain Centers

    Shrewsbury, New Jersey, 07702

  • IPM Medical Group

    Walnut Creek, California, 94598

  • International Spine, Pain & 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 Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)

Being tested
SPRINT Peripheral Nerve Stimulation (PNS) System, Standard interventional management of low back pain
Keywords
Electrical Stimulation, Neuromodulation
Medical subject headings
Low Back Pain, 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

    The SPRINT System delivers mild electrical stimulation to the nerves in your low back. The SPRINT System includes up to two leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).

  • Standard interventional management of low back painProcedure or surgery

    Your doctor will determine which procedure or intervention is appropriate for your back pain. You may receive radiofrequency ablation, spinal cord stimulation, surgery, or another procedure or treatment, as appropriate.

Study groups in NCT04246281
Study groupRoleWhat they receive
Group 1: Peripheral Nerve Stimulation (PNS)Active comparatorSubjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
Receives: Device: SPRINT Peripheral Nerve Stimulation (PNS) System
Group 2: Standard Interventional Management (Standard of Care)Active comparatorSubjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).
Receives: Procedure: Standard interventional management of low back pain

What is being measured

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

  1. Reduction in average pain intensity

    Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.

    Measured: Up to 3-months after Start of Therapy (SOT)

  2. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: During the Medial Branch Block procedure

  3. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: During the Lead Placement procedure (SOT)

  4. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 1-week post-SOT

  5. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 2-weeks post-SOT

  6. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 3-weeks post-SOT

  7. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 4-weeks post-SOT

  8. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 5-weeks post-SOT

  9. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 6-weeks post-SOT

  10. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 7-weeks post-SOT

  11. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 8-weeks post-SOT

  12. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 3-months post-SOT

  13. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 6-months post-SOT

  14. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 9-months post-SOT

  15. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 12-months post-SOT

  16. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 18-months post-SOT

  17. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 24-months post-SOT

Secondary outcomes (7)

  1. Reduction in pain interference

    Measured using question 9 from the Brief Pain Inventory- Short Form. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week.

    Measured: Baseline, 3-months after SOT

  2. Reduction in disability

    Measured using the Oswestry Disability Index (ODI). The ODI asks subjects to rate how their back pain impacts ten components of everyday life. For each section, the answers correlate to a scale which ranges from 0 to 5, where 0 is no disability and 5 is maximum disability.

    Measured: Baseline, 3-months after SOT

  3. Durability of reductions in pain intensity

    Measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.

    Measured: Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT

  4. Reduction in worst pain intensity

    Measured using question 3 from the Brief Pain Inventory- Short Form (BPI-3). BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.

    Measured: Baseline, 3-months after SOT

  5. Patient Global Impression of Change

    Measured using the Patient Global Impression of Change (PGIC) survey. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.

    Measured: 3-months after SOT

  6. Change in health-related quality of life

    Measured using the EQ-5D survey. The EQ-5D is a five-level scale. Each level is coded from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The EQ-5D also includes a 0 to 100 scale for health status, where 0 indicates "the worst health you can imagine" and 100 indicates "the best health you can imagine".

    Measured: Baseline, 3-months after SOT

  7. Change in analgesic medication usage

    Analgesic medication consumption will be collected.

    Measured: Baseline, 3-months after SOT

Timeline

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

  1. First posted29 Jan 2020
  2. Study start17 Jun 2020
  3. Primary completion27 Apr 2026
  4. Study completion27 Apr 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246281
Sponsor's protocol ID
0151-CSP-000
Other IDs
CDMRP-PR170708
Status last verified
May 2026
First submitted
19 Dec 2019
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Li S, McCormick ZL, Lester DD, DePalma MJ, Gilmore CA, Jameson JB, Desai MJ, Weaver TE, Lad SP, Davidoff SJ, Trainor DM, Amirdelfan K, Engle MP, Deer TR, Lee TS, Vetri F, Bindal M, Tornero-Bold MA, Nasseri MN, Cohen SP, Clark WH, McGee MJ, Boggs JW. Observations from the RESET clinical trial: A post-hoc per protocol analysis of clinical outcomes with percutaneous 60-day medial branch PNS in chronic low back pain. Interv Pain Med. 2026 Jun 6;5(2):100775. doi: 10.1016/j.inpm.2026.100775. eCollection 2026 Jun.

    PubMed 42290901

Questions about this trial

What is this clinical trial studying?

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System and Standard interventional management of low back pain in people with Low Back Pain and Back Pain, run by SPR Therapeutics, Inc. at 18 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 1 inclusion and 4 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Reduction in average pain intensity (time frame: Up to 3-months after Start of Therapy (SOT)). The study lists 17 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 NCT04246281, which also lists 1 linked publication.

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 27 May 2026.

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