N/A
Completed N=47
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
Total Knee Replacement · Total Knee Arthroplasty · Postoperative Pain · Orthopedic Disorder
Source: ClinicalTrials.gov NCT03286543 ↗
Enrolled (actual)
47
Serious AEs
12.2%
Results posted
May 2021
Primary outcomePrimary: Average Knee Pain While Walking — 3.70; 4.14 Scores on a scale
Summary
The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. This study involves a device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator). About half the subjects in this study will receive the SPRINT Beta system (treatment group) and half will not (control group). Both groups will receive the standard of care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Knee Pain While Walking |
3.70; 4.14 | — |
| PRIMARY Number of Subjects That Experienced at Least One Study-Related Adverse Event |
8 | — |
| SECONDARY Average Knee Pain Over the Last 24 Hours |
3.24; 4.32 | — |
| SECONDARY Average Knee Pain at Rest |
2.86; 3.48 | — |
| SECONDARY Pain Right Now as Measured by the Brief Pain Inventory |
1.0; 3.0; 2.0; 2.0; 2.0; 3.5 | — |
| SECONDARY Amount of Analgesic Usage |
29.9; 31.4; 21.4; 22.5; 13.6; 17.1 | — |
| SECONDARY Number of Subjects That Experienced at Least One Opioid-Related Side Effect |
0; 0; 3; 7; 3; 9 | — |
| SECONDARY Timed Up and Go (TUG) Test |
12.44; 10.25; 41.80; 42.22; 14.28; 15.93 | — |
| SECONDARY Six Minute Walk Test (6MWT) |
458.5; 351.3; 280.0; 281.0; 410.0; 329.0 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
87.00; 111.31; 68.71; 99.23; 58.57; 81.13 | — |
| SECONDARY Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey |
0; 1; 5; 14; 2; 1 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
7; 7; 6; 4; 1; 0 | — |
| SECONDARY Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA) |
3; 2; 0; 1; 24; 16 | — |
| SECONDARY Subject Satisfaction Survey |
7; 5; 4; 7; 7; 7 | — |
| SECONDARY Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty |
2; 2; 3; 3; 2; 3 | — |
| SECONDARY Subject's Use of Device (Compliance) |
79; 73; 358; 373.5; 646; 633 | — |
| SECONDARY Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay) |
0; 0; 1; 3; 3; 4 | — |
| SECONDARY Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay) |
6; 13 | — |
| SECONDARY Inpatient Pain Management Experience Survey (Discharge Facility) |
7; 11; 0; 1; 0; 1 | — |
| SECONDARY Inpatient Pain Management Experience Survey (Overall Rating of Hospital) |
10; 10 | — |
Eligibility Criteria
Key Inclusion Criteria
- Scheduled to undergo a primary unilateral total knee replacement procedure
Key Exclusion Criteria
- Body Mass Index > 40 kg/m2
- Conditions that place the subject at increased risk of infection
- History of valvular heart disease
- Implanted electronic device
- Bleeding disorder
- Allergy to skin surface electrodes and/or medical-grade adhesive tapes
- Pregnant
Data sourced from ClinicalTrials.gov (NCT03286543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.