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

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ClinicalTrials.gov Identifier: NCT03179202
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2017
First Posted Date  ICMJE June 7, 2017
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE June 23, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Clinically significant reduction in "average pain" intensity (measured using Brief Pain Inventory, question #5) at the end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Study related adverse event rates [ Time Frame: During lead placement ]
  • Study related adverse event rates [ Time Frame: 24-48 hours post lead placement ]
  • Study related adverse event rates [ Time Frame: 1-week post lead placement ]
  • Study related adverse event rates [ Time Frame: 2-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 3-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 4-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 5-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 6-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 7-weeks post lead placement ]
  • Study related adverse event rates [ Time Frame: 8-weeks post lead placement/End of Treatment (EOT) ]
  • Study related adverse event rates [ Time Frame: 1-month post End of Treatment (EOT) ]
  • Study related adverse event rates [ Time Frame: 3-months post End of Treatment (EOT) ]
  • Study related adverse event rates [ Time Frame: 6-months post End of Treatment (EOT) ]
  • Study related adverse event rates [ Time Frame: 9-months post End of Treatment (EOT) ]
  • Study related adverse event rates [ Time Frame: 12-months post End of Treatment (EOT) ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Change in "average pain" intensity (measured using Brief Pain Inventory, question #5) at the end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Device related adverse event rates [ Time Frame: During lead placement ]
  • Device related adverse event rates [ Time Frame: 24-48 hours post lead placement ]
  • Device related adverse event rates [ Time Frame: 1-week post lead placement ]
  • Device related adverse event rates [ Time Frame: 2-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 3-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 4-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 5-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 6-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 7-weeks post lead placement ]
  • Device related adverse event rates [ Time Frame: 8-weeks post lead placement/End of Treatment (EOT) ]
  • Device related adverse event rates [ Time Frame: 1-week post EOT ]
  • Device related adverse event rates [ Time Frame: 3-months post EOT ]
  • Device related adverse event rates [ Time Frame: 6-months post EOT ]
  • Device related adverse event rates [ Time Frame: 9-months post EOT ]
  • Device related adverse event rates [ Time Frame: 12-months post EOT ]
Change History Complete list of historical versions of study NCT03179202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Change in "worst pain intensity" (measured using Brief Pain Inventory, question #3) at the end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Change in disability (measured using Oswestry Disability Index) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Change in health-related quality of life (measured using RAND 36-Item Health Survey) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Change in emotional state (measured using Beck Depression Inventory) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  • Patient Global Impression of Change (PGIC) score [ Time Frame: 8 weeks ]
  • Change in pain interference (measured using Brief Pain Inventory, question #9) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
Official Title  ICMJE A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Low Back Pain
Intervention  ICMJE 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:
  • SPRINT System
  • Smartpatch System
  • SPRINT
  • Smartpatch
Study Arms  ICMJE 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.
Intervention: Device: SPRINT Peripheral Nerve Stimulation (PNS) System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
50
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03179202
Other Study ID Numbers  ICMJE 0142-CSP-000
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SPR Therapeutics, Inc.
Study Sponsor  ICMJE SPR Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SPR Therapeutics, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP