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

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).

Study Overview

• Status: Completed
• Conditions: Back Pain; Low Back Pain
• Intervention / Treatment: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• At least 21 years of age
• Chronic low back pain

Key Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peripheral Nerve Stimulation; 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.

Device: SPRINT Peripheral Nerve Stimulation (PNS) System; 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.; Other Names: Smartpatch System; SPRINT; SPRINT System; Smartpatch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)

Collaborators and Investigators

• Sponsor: SPR Therapeutics, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: Pain Med. 2021 May 06;:

Helpful Links

• Study Website
• Sponsor's Website

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Neuromodulation; Low Back Pain; Back Pain; Electrical Stimulation; Neurostimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 0142-CSP-000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes