N/A
N=70
Pulsed Shortwave Therapy for Postoperative Analgesia
Postoperative Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT05796583 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Pain Measured With the Numeric Rating Scale — 28; 34 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Pulsed Shortwave Treatment (Device); Sham Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Measured With the Numeric Rating Scale |
28; 34 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
.2; .3 | — |
| SECONDARY Median AVERAGE Pain Measured With the Numeric Rating Scale |
1.8; 3.3 | — |
| SECONDARY Median WORST Pain Measured With the Numeric Rating Scale |
5.0; 5.5 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .6 | — |
| SECONDARY LEAST Pain Measured With the Numeric Rating Scale |
.3; .4 | — |
| SECONDARY LEAST Pain Measured With the Numeric Rating Scale |
.3; .4 | — |
| SECONDARY CURRENT Pain Measured With the Numeric Rating Scale |
.6; 1.2 | — |
| SECONDARY CURRENT Pain Measured With the Numeric Rating Scale |
.6; 1.2 | — |
| SECONDARY Total OPIOID Consumption for Postoperative Days 1, 2, 3, and 7 (Measured in Oral Oxycodone Equivalents) |
4.6; 5.1 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0.1; .0 | — |
| SECONDARY Brief Pain Inventory, Short Form (Interference Subscale) |
6.5; 9 | — |
| SECONDARY Brief Pain Inventory, Short Form (Interference Subscale) |
6.5; 9 | — |
| SECONDARY Awakenings Due to Pain |
.3; .9 | — |
| SECONDARY Awakenings Due to Pain |
.3; .9 | — |
| SECONDARY Awakenings Due to Pain |
.3; .9 | — |
| SECONDARY Awakenings Due to Pain |
.3; .9 | — |
| SECONDARY Awakenings Due to Pain |
.3; .9 | — |
| SECONDARY Hospitalization Duration Measured in Days |
.4; .4 | — |
| SECONDARY Surgical Duration |
78; 88 | — |
| SECONDARY Device Location Changes |
0; 0 | — |
| SECONDARY Device Location Changes |
0; 0 | — |
| SECONDARY Device Location Changes |
0; 0 | — |
| SECONDARY Device Location Changes |
0; 0 | — |
| SECONDARY Device Location Changes |
0; 0 | — |
| SECONDARY Passive Joint Flexion |
0; 0 | — |
Summary
Pulsed shortwave (radiofrequency) therapy is a possible method of pain control involving the application of electromagnetic energy (also termed pulsed electromagnetic fields). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 8 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this study is to explore the possibility of treating acute postoperative pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect.
Eligibility Criteria
Adult patients of at least 18 years of age undergoing one of these primary surgical procedures:
- primary knee arthroplasty
- primary hip arthroplasty
- cholecystectomy
Exclusion Criteria
- concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
- pregnancy
- incarceration
- chronic opioid/tramadol use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- neuro-muscular deficit of the surgical area/limb
- a planned postoperative perineural local anesthetic infusion
Data sourced from ClinicalTrials.gov (NCT05796583). 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.