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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341948
• Other study ID #: 0150-CSP-000
• Secondary ID: CDMRP-OR170165
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: SPR Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

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).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	The Orthopaedic Institute	Gainesville	Florida
United States	Ali K. Valimahomed MD PLLC	Holmdel	New Jersey
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Better Health Clinical Research, Inc	Newnan	Georgia
United States	UT Health San Antonio	San Antonio	Texas
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
SPR Therapeutics, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in average pain intensity	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).	Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	During Lead placement at SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	24-48 hours post-Lead placement
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	1-week post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	2-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	4-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	5-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	7-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	8-weeks post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-months post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-months post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	9-months post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	12-months post-SOT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	During Lead placement at Start of optional Crossover Treatment (SOCT)
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	24-48 hours post-Lead placement SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	2-weeks post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	4-weeks post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	8-weeks post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-months post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-months post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	9-months post-SOCT
Primary	Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	12-months post-SOCT
Secondary	Average pain intensity	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).	Baseline, 1-week post-SOT thru 4-weeks post-SOT
Secondary	Mean pain relief	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).	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
Secondary	Long-term durability of average pain intensity	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).	Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Secondary	Pain medication usage	Medications collected for each diary collection period	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
Secondary	Pain Catastrophizing Scale (PCS)	PCS is a 13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions).	Baseline, 4-weeks post-SOT, 8-weeks post-SOT
Secondary	Patient Global Impression of Change (PGIC)	PGIC assesses the patient's impression of change in quality of life.	4-weeks post-SOT, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Secondary	Pain interference	Measured using the average pain interference (question 9 from the Brief Pain Inventory-SF, BPI-9).	Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Secondary	Function (i.e. physical recovery)	Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).	Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Secondary	Six Minute Walk Test (6MWT)	The 6MWT measures the distance walked in 6 minutes and will be used to assess walking speed and endurance.	Baseline, 8-weeks post-SOT, 3-months post-SOT