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 :
Active, not recruiting
First Posted : April 10, 2020
Last Update Posted : December 19, 2023
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Condition or disease | Intervention/treatment | Phase |
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Postoperative Pain Total Knee Replacement Total Knee Arthroplasty Partial Knee Replacement | Device: SPRINT Peripheral Nerve Stimulation (PNS) System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 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 : | July 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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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.
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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:
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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.
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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:
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- 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).
- Study-Related Adverse Device Effects [ Time Frame: During Lead placement at SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 1-week post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment (SOCT) ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOCT ]Occurrence and type of study-related AEs
- Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOCT ]Occurrence and type of study-related AEs
- 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).
- 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).
- 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).
- 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
- 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).
- 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.
- 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).
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- At least 21 years old
- Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)
- Knee pain directly resulting from Knee Replacement surgery 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.
- Uncontrolled Diabetes Mellitus Types I or II
- Pregnancy
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
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
University of California San Diego | |
San Diego, California, United States, 92103 | |
United States, Florida | |
The Orthopaedic Institute | |
Gainesville, Florida, United States, 32607 | |
United States, Georgia | |
Better Health Clinical Research, Inc | |
Newnan, Georgia, United States, 30265 | |
United States, Illinois | |
NorthShore University HealthSystem | |
Evanston, Illinois, United States, 60201 | |
United States, Louisiana | |
Ochsner Clinic Foundation | |
New Orleans, Louisiana, United States, 70115 | |
United States, New Jersey | |
Ali K. Valimahomed MD PLLC | |
Holmdel, New Jersey, United States, 07733 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Texas | |
UT Health San Antonio | |
San Antonio, Texas, United States, 78229 |
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: | December 19, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Pain, Postoperative Musculoskeletal Diseases Postoperative Complications Nervous System Diseases |
Pain Neurologic Manifestations Signs and Symptoms |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |