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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 : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Back Pain Low Back Pain Device: SPRINT Peripheral Nerve Stimulation (PNS) System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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:
  • SPRINT System
  • Smartpatch System
  • SPRINT
  • Smartpatch




Primary Outcome Measures :
  1. 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 ]
  2. Study related adverse event rates [ Time Frame: During lead placement ]
  3. Study related adverse event rates [ Time Frame: 24-48 hours post lead placement ]
  4. Study related adverse event rates [ Time Frame: 1-week post lead placement ]
  5. Study related adverse event rates [ Time Frame: 2-weeks post lead placement ]
  6. Study related adverse event rates [ Time Frame: 3-weeks post lead placement ]
  7. Study related adverse event rates [ Time Frame: 4-weeks post lead placement ]
  8. Study related adverse event rates [ Time Frame: 5-weeks post lead placement ]
  9. Study related adverse event rates [ Time Frame: 6-weeks post lead placement ]
  10. Study related adverse event rates [ Time Frame: 7-weeks post lead placement ]
  11. Study related adverse event rates [ Time Frame: 8-weeks post lead placement/End of Treatment (EOT) ]
  12. Study related adverse event rates [ Time Frame: 1-month post End of Treatment (EOT) ]
  13. Study related adverse event rates [ Time Frame: 3-months post End of Treatment (EOT) ]
  14. Study related adverse event rates [ Time Frame: 6-months post End of Treatment (EOT) ]
  15. Study related adverse event rates [ Time Frame: 9-months post End of Treatment (EOT) ]
  16. Study related adverse event rates [ Time Frame: 12-months post End of Treatment (EOT) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in disability (measured using Oswestry Disability Index) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  3. 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 ]
  4. Change in emotional state (measured using Beck Depression Inventory) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]
  5. Patient Global Impression of Change (PGIC) score [ Time Frame: 8 weeks ]
  6. Change in pain interference (measured using Brief Pain Inventory, question #9) at end of treatment compared to baseline [ Time Frame: Baseline and 8 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179202


Locations
United States, Arizona
Hope Research Institute Recruiting
Peoria, Arizona, United States, 85381
Contact: Norma Frederick    602-288-4673    norma.frederick@hriaz.com   
Principal Investigator: Abram Burgher, MD         
United States, California
Integrated Pain Management Medical Group Recruiting
Walnut Creek, California, United States, 94598
Contact: Jon Briz    925-478-5490    jbriz@ipmdoctors.com   
Principal Investigator: Kasra Amirdelfan, MD         
United States, District of Columbia
International Spine, Pain and Performance Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Sidrah Sheikh    202-808-8295    ssheikh@isppcenter.com   
Principal Investigator: Mehul Desai, MD, MPH         
United States, New Jersey
Premier Pain Centers Recruiting
Shrewsbury, New Jersey, United States, 07702
Contact: Mandy Mead    732-930-2423    mmead@treatingpain.com   
Principal Investigator: Sean Li, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Allison Spell    919-681-4937    allison.spell@duke.edu   
Principal Investigator: Thomas Hopkins, MD         
Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Kimberly Debty    336-765-6181    kdebty@ccrpain.com   
Principal Investigator: Leonardo Kapural, MD, PhD         
United States, Virginia
Virginia iSpine Physicians Recruiting
Richmond, Virginia, United States, 23235
Contact: Janet Baker    804-330-2611    crc2@vaispine.com   
Principal Investigator: Michael DePalma, MD         
United States, West Virginia
The Spine and Nerve Center of St. Francis Hospital Recruiting
Charleston, West Virginia, United States, 25301
Contact: Amy Young    304-347-6144    Amy.Young@ThomasHealth.org   
Principal Investigator: Timothy Deer, MD         
Sponsors and Collaborators
SPR Therapeutics, Inc.

Additional Information:
Responsible Party: SPR Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03179202     History of Changes
Other Study ID Numbers: 0142-CSP-000
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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

Keywords provided by SPR Therapeutics, Inc.:
Electrical Stimulation
Neurostimulation
Neuromodulation
Back Pain
Low Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms