Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
1 other identifier
interventional
166
1 country
8
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2021
CompletedResults Posted
Study results publicly available
August 5, 2022
CompletedAugust 5, 2022
July 1, 2022
3.9 years
June 1, 2017
May 10, 2022
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to 15 months for each subject from baseline to the last study visit
Secondary Outcomes (6)
Worst Pain Intensity
Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Oswestry Disability Index (ODI)
Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Mean Change in Health-Related Quality of Life
Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Beck Depression Inventory (BDI-II)
Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Patient Global Impression of Change (PGIC) Survey
8-weeks post-Start of Treatment (SOT)
- +1 more secondary outcomes
Study Arms (1)
Peripheral Nerve Stimulation
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 21 years of age
- Chronic low back pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hope Research Institute
Peoria, Arizona, 85381, United States
Integrated Pain Management Medical Group
Walnut Creek, California, 94598, United States
International Spine, Pain and Performance Center
Washington D.C., District of Columbia, 20006, United States
Premier Pain Centers
Shrewsbury, New Jersey, 07702, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Virginia iSpine Physicians
Richmond, Virginia, 23235, United States
The Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia, 25301, United States
Related Publications (2)
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.
PMID: 40261580DERIVEDDeer 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.
PMID: 33616178DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- SPR Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2017
First Posted
June 7, 2017
Study Start
June 23, 2017
Primary Completion
May 11, 2021
Study Completion
May 11, 2021
Last Updated
August 5, 2022
Results First Posted
August 5, 2022
Record last verified: 2022-07