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

Not Applicable

Completed

Conditions: Total Knee Arthroplasty
Partial Knee Replacement
Postoperative Pain
Total Knee Replacement

Registration Number: NCT04341948

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity	Baseline and 5 to 8 weeks post-Start of Treatment (SOT)	All participants were asked to complete daily diaries to record their average knee pain during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day diary(s) at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in average knee pain. The number of successes is presented.
Study-Related Adverse Device Effects	Up to 13 months for each Group 1 participant and up to 16 months for Group 2 participants that opted to cross over (time from baseline to last study visit)	At each study visit following the baseline assessment at Visit 1, participants were questioned if any changes in their medical status or condition have occurred since their previous visit. If the participant experienced a change that was a study-related adverse event, an Adverse Event Form was completed by the site. The number of participants that experienced at least one study-related adverse event is reported here. Adverse Events are reported by the trial phase in which they occurred: Group 1 Treatment (active stimulation), Group 2 Control (sham stimulation), and Group 2 Crossover Safety Set (active stimulation).

Secondary Outcome Measures

Name	Time	Method
Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity	Baseline and 1 to 4-weeks post-start of treatment (SOT)	All participants were asked to complete daily diaries to record their average knee pain intensity during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain score was calculated across the 7-day diary(s) at baseline and across weeks 1 to 4 post-start of treatment. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in average knee pain. The number of successes is presented.
Pain Medication Usage	Baseline, 1 to 4 weeks post-start of treatment (SOT), and 5 to 8 weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT	Participants recorded the amount/type of analgesics used in daily diaries. A blinded, third-party medication committee reviewed participants' diary medications for each time period to determine if each participant's analgesic usage changed. The committee determined whether there was No change (no change in dosage or change is not clinically meaningful to impact pain outcomes), an Increase (clinically meaningful increase in medication that would impact pain outcomes), or a Decrease (clinically meaningful decrease in medication that would impact pain outcomes) for each time period compared to baseline. The number of participants with a Decrease in analgesic medication usage for pain are reported. Participants that did not report any pain medications during the study were excluded from the analysis.
Pain Catastrophizing Scale (PCS)	Baseline (Visit 1), 4-weeks post-SOT (Visit 6), and 8-weeks post-SOT (Visit 10)	The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Participants are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each participant to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The mean score for each time point is presented.
Patient Global Impression of Change (PGIC)	4-weeks post-start of treatment (SOT)(Visit 6), 8-weeks post-SOT (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14)	The Patient Global Impression of Change (PGIC) Survey asks participants to rate their improvement with treatment on a 7-point scale ranging from -3 to 0 to +3, where -3 represents "very much worse," 0 is "no change," and +3 represents "very much improved" as compared to before stimulation treatment. The participants combine all the components of their experience into one overall score. The mean score of each group was calculated for each time frame.
Pain Interference: Number of Participants With ≥ 50% Reduction in Pain Interference	Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14)	Question 9 of the Brief Pain Inventory-Short Form (BPI-9) is a 7-part question that assesses the level of interference that participants experience in their daily lives due to pain. The 7 categories are general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Participants were asked to rate how much their post-surgical knee pain interferes with each aspect on an 11-point numerical scale where 0 represents "Does Not Interfere" and 10 represents "Completely Interferes." The average of these 7 scores was calculated for each participant at each time point. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in pain interference. The number of successes is presented.
Function (i.e., Physical Recovery)	Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14)	The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each participant, the scores from each of the 24 items were averaged to calculate the participant's total score, with a minimum score of 0 and a maximum score of 10. The mean total score was then calculated across participants and percent reduction was calculated for each time point. To be considered a success, participants must have experienced ≥ 33% reduction in their score. The number of successes is presented.
Long-term Durability of Average Pain Relief: Number of Participants With ≥ 50% Reduction in Average Pain Intensity	Baseline, 3-months post-start of treatment (SOT), 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	All participants were asked to complete daily diaries to record their average knee pain intensity during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain score was calculated across the 7-day diary for each participant at baseline and at 3-, 6-, 9-, and 12-months post-start of treatment. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in average knee pain. The number of successes is presented.
Mean Pain Relief	Baseline, 1 to 4-weeks post-start of treatment (SOT), 5 to 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT	All participants were asked to complete daily diaries to record their average knee pain intensity during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The mean pain score was calculated across the 7-day diary(s) for each participant at baseline, 1-4 weeks post-start of treatment (SOT), 5-8 weeks post-SOT, and at 3-, 6-, 9-, and 12-months post-SOT. The mean pain score is presented.
Six Minute Walk Test (6MWT)	Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), and 3-months post-SOT (Visit 11)	The total distance that a participant could walk in 6 minutes was recorded, and participants unable to walk at all were given a score of 0 meters. The mean distance was then determined across participants. The baseline score was compared to the score at the specified intervals after start of therapy.

Trial Locations

Locations (10): University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
University of California San Diego
🇺🇸
San Diego, California, United States
The Orthopaedic Institute
🇺🇸
Gainesville, Florida, United States
Better Health Clinical Research, Inc
🇺🇸
Newnan, Georgia, United States
NorthShore University HealthSystem
🇺🇸
Evanston, Illinois, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Ali K. Valimahomed MD PLLC
🇺🇸
Holmdel, New Jersey, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Duke University
🇺🇸
Durham, North Carolina, United States
UT Health San Antonio
🇺🇸
San Antonio, Texas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States