N/A
Completed N=119
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
Postoperative Pain, Acute
Source: ClinicalTrials.gov NCT05399355 ↗
Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: AVERAGE Pain Measured With the Numeric Rating Scale — 2.4; 2.6 score on a scale
Summary
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). 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 30 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 pilot 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 in preparation for developing subsequent definitive clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AVERAGE Pain Measured With the Numeric Rating Scale |
0; .1 | — |
| PRIMARY WORST Pain Measured With the Numeric Rating Scale |
.3; .4 | — |
| PRIMARY Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents) |
21; 17 | — |
| SECONDARY AVERAGE Pain Measured With the Numeric Rating Scale |
0; .1 | — |
| SECONDARY WORST Pain Measured With the Numeric Rating Scale |
.3; .4 | — |
| SECONDARY LEAST Pain Measured With the Numeric Rating Scale |
.3; .2 | — |
| SECONDARY CURRENT Pain Measured With the Numeric Rating Scale |
.5; .4 | — |
| SECONDARY Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) |
0; 0 | — |
| SECONDARY Brief Pain Inventory, Short Form (Interference Subscale) |
.6; .3 | — |
| SECONDARY Awakenings Due to Pain |
.5; .2 | — |
| SECONDARY Hospitalization Duration Measured in Days |
.3; .3 | — |
| SECONDARY Passive Flexion (Knee and Hip Arthroplasty Patients Only) |
— | — |
| SECONDARY Day Stopped Using Intervention |
21.3; 23.4 | — |
| SECONDARY Desire Use of Device in Hypothetical Future Surgery? |
— | — |
| SECONDARY Surgical Start as Recorded Using Military Time Format |
— | — |
| SECONDARY Surgical Stop as Recorded Using Military Time Format |
— | — |
| SECONDARY Surgical Duration |
— | — |
| SECONDARY Device Location Changes |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Adult patients of at least 18 years of age undergoing one of these primary surgical procedures:
- non-mastectomy breast surgery with a single-injection paravertebral nerve block
- laparoscopic cholecystectomy
- laparoscopic sleeve gastrectomy
- percutaneous nephrolithotomy
- ventral hernia repair
- inguinal hernia repair
- knee or hip arthroplasty
- foot/ankle surgery with at least moderate pain anticipated
- shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair)
- hand/forearm/elbow surgery with at least moderate pain anticipated
- spinal surgery with at least moderate pain anticipated
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 (NCT05399355). 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.