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Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System

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ClinicalTrials.gov Identifier: NCT04341948
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
SPR Therapeutics, Inc.

Brief Summary:
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.

Condition or disease Intervention/treatment Phase
Postoperative Pain Total Knee Replacement Total Knee Arthroplasty Device: SPRINT Peripheral Nerve Stimulation (PNS) System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Active Comparator: Group 1 (Treatment)
Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Other Names:
  • SPRINT
  • SPRINT System

Sham Comparator: Group 2 (Control)
Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy.
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Other Names:
  • SPRINT
  • SPRINT System




Primary Outcome Measures :
  1. Reduction in average pain intensity [ Time Frame: Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT ]
    Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

  2. Study-Related Adverse Device Effects [ Time Frame: During Lead placement at SOT ]
    Occurrence and type of study-related AEs

  3. Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]
    Occurrence and type of study-related AEs

  4. Study-Related Adverse Device Effects [ Time Frame: 1-week post-SOT ]
    Occurrence and type of study-related AEs

  5. Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOT ]
    Occurrence and type of study-related AEs

  6. Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-SOT ]
    Occurrence and type of study-related AEs

  7. Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOT ]
    Occurrence and type of study-related AEs

  8. Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-SOT ]
    Occurrence and type of study-related AEs

  9. Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-SOT ]
    Occurrence and type of study-related AEs

  10. Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-SOT ]
    Occurrence and type of study-related AEs

  11. Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOT ]
    Occurrence and type of study-related AEs

  12. Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOT ]
    Occurrence and type of study-related AEs

  13. Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOT ]
    Occurrence and type of study-related AEs

  14. Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOT ]
    Occurrence and type of study-related AEs

  15. Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOT ]
    Occurrence and type of study-related AEs

  16. Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment (SOCT) ]
    Occurrence and type of study-related AEs

  17. Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement SOCT ]
    Occurrence and type of study-related AEs

  18. Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOCT ]
    Occurrence and type of study-related AEs

  19. Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOCT ]
    Occurrence and type of study-related AEs

  20. Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOCT ]
    Occurrence and type of study-related AEs

  21. Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOCT ]
    Occurrence and type of study-related AEs

  22. Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOCT ]
    Occurrence and type of study-related AEs

  23. Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOCT ]
    Occurrence and type of study-related AEs

  24. Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOCT ]
    Occurrence and type of study-related AEs


Secondary Outcome Measures :
  1. Average pain intensity [ Time Frame: Baseline, 1-week post-SOT thru 4-weeks post-SOT ]
    Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

  2. Mean pain relief [ Time Frame: Baseline, 1-week post-SOT thru 4-weeks post-SOT, 5-weeks post-SOT thru 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

  3. Long-term durability of average pain intensity [ Time Frame: Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

  4. Pain medication usage [ Time Frame: Baseline, 1-week post-SOT thru 4-weeks post-SOT, and 5-weeks post thru SOT-8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    Medications collected for each diary collection period

  5. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 4-weeks post-SOT, 8-weeks post-SOT ]
    PCS is a 13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions).

  6. Patient Global Impression of Change (PGIC) [ Time Frame: 4-weeks post-SOT, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    PGIC assesses the patient's impression of change in quality of life.

  7. Pain interference [ Time Frame: Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    Measured using the average pain interference (question 9 from the Brief Pain Inventory-SF, BPI-9).

  8. Function (i.e. physical recovery) [ Time Frame: Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT ]
    Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

  9. Six Minute Walk Test (6MWT) [ Time Frame: Baseline, 8-weeks post-SOT, 3-months post-SOT ]
    The 6MWT measures the distance walked in 6 minutes and will be used to assess walking speed and endurance.



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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 old
  • Underwent a primary unilateral total knee replacement procedure
  • Knee pain directly resulting from Total Knee Replacement in affected knee

Key Exclusion Criteria:

  • Current high opioid use
  • Body Mass Index (BMI) > 40 kg/m2
  • Conditions with increased risk of infection
  • Implanted electronic device
  • History of bleeding or clotting disorder.
  • Surgery on the affected knee since the primary Total Knee Replacement
  • Uncontrolled Diabetes Mellitus Types I or II
  • Pregnancy

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): NCT04341948


Contacts
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Contact: Elizabeth Deyling 844-378-9108 edeyling@sprtherapeutics.com

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alicia DeAguero, MS    501-214-2410    badeaguero@uams.edu   
Principal Investigator: Johnathan H Goree, MD         
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Baharin Abdullah    858-344-4144    baabdullah@health.ucsd.edu   
Principal Investigator: Brian M. Ilfeld, MD, MS         
United States, Florida
The Orthopaedic Institute Recruiting
Gainesville, Florida, United States, 32607
Contact: Gretchen Kostedt, RN    352-336-6000    gkostedt@toi-health.com   
Principal Investigator: Ajay Antony, MD         
United States, Georgia
Better Health Clinical Research, Inc Recruiting
Newnan, Georgia, United States, 30265
Contact: Debra Helton    770-252-7562    dhelton@gapaincare.com   
Principal Investigator: Sandeep Vaid, MD         
United States, Kansas
Neuroscience Research Center, LLC Recruiting
Overland Park, Kansas, United States, 66210
Contact: Nicole Ladesich, MHSA    913-339-9437    nicole.l@neuroscienceresearchctr.com   
Principal Investigator: Mayank Gupta, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Colleen M. Dionne    504-894-2864    Colleen.dionne@ochsner.org   
Principal Investigator: Yashar Eshraghi, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michelle Becton    919-843-6575    michelle_becton@med.unc.edu   
Principal Investigator: Stuart Grant, MB, ChB         
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Dan Mungal, BA    919-613-2609    daniel.mungal@duke.edu   
Principal Investigator: Brian Ohlendorf, MD         
Sponsors and Collaborators
SPR Therapeutics, Inc.
United States Department of Defense
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Responsible Party: SPR Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04341948    
Other Study ID Numbers: 0150-CSP-000
CDMRP-OR170165 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SPR Therapeutics, Inc.:
Pain, Postoperative
Musculoskeletal Diseases
Postoperative Complications
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations