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Completed

NCT Number: NCT05399355

Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92103, United States

About this study

The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants pilot study with two primary aims:

Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures.

Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures. This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials.

Hypothesis 1: Nonthermal, pulsed shortwave therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures.

Hypothesis 2: Nonthermal, pulsed shortwave therapy decreases opioid use in the 7 days following moderate-to-severely painful surgical procedures.

This will be a single-center (University of California San Diego), randomized, participant- and observer-masked, sham-controlled, parallel-arm human subjects pilot study.

Enrollment. Participants will be consenting adults undergoing various surgical procedures usually resulting in moderate-to-severe postoperative pain. Study inclusion will be proposed to eligible presurgical patients. If an individual desires study participation, written, informed consent will be obtained using a current University of California San Diego Institutional Review Board-approved informed consent form. The study population of interest includes adult women and men of all races, ethnicity, sexual identity, and socioeconomic status.

Procedures. Following written, informed consent, we will record baseline anthropometric information (age, sex, height, weight, amputation details and current pain levels). Participants will receive any standard peripheral nerve block(s) administered using bupivacaine or ropivacaine 0.5% with epinephrine (standard at University of California San Diego) prior to undergoing their surgical procedure per standard of care.

Treatment Group Assignment. Each participant will be randomized to one of two treatment groups: Active or Sham treatment. There are sham devices produced that are identical to active devices, only they do not deliver pulsed electromagnetic energy. Randomization will be stratified by surgical procedure in block sizes of 2. The computer-generated randomization lists will be created by the University of California San Diego Investigational Drug Service in a 1:1 treatment group ratio using opaque envelopes. The active and sham devices are indistinguishable in appearance, and therefore investigators, participants, and all clinical staff other than the individual who opens the randomization envelope and chooses a sham or active device will be masked to treatment group assignment for the duration of the data collection period. An Investigational Drug Service pharmacist will open the envelope and provide the investigators with the appropriate device, keeping all investigators masked to treatment group assignment. Upon completion of data collection for a specific subgroup (e.g., amputees, total knee arthroplasty), the pharmacist will provide the investigators with a masked list of the treatment groups (e.g., "Treatment A" and "Treatment B"), and the active/sham lists only following analysis for that subgroup, resulting in a triple-masked study (investigators, participants, statistician).

Study intervention. The pulsed shortwave device (2 devices, if there are multiple incisions or the incision is larger than the device diameter; 3 devices for total knee and hip arthroplasty or spinal surgery) will be affixed over the primary wound area(s) using tape and activated prior to recovery room discharge (Experimental). The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this pilot study, and patients will be encouraged to move the devices to a new anatomic location until relief is optimized.

Supplemental analgesics. In addition to the pulsed shortwave device(s), participants will receive standard-of-care supplemental analgesics which can include acetaminophen, ibuprofen, ketorolac, opioids, gabapentin (this is provider- and patient-dependent). Therefore, all patients of this study-regardless of the treatment arm they are randomized to-will continue to receive current usual and customary analgesia: all will receive the same combination of supplemental analgesics they would regardless of study participation. Participants (and their caretakers) will be provided with verbal and written instructions, and the telephone and pager numbers of an investigator available during business hours throughout the treatment period. Participants can shower with the device in place, but not submerge it during swimming or a bath, as advised by the manufacturer.

Participants will be discharged with their pulsed shortwave device(s) in situ and a prescription for immediate-release oral opioid, preferably oxycodone 5 mg tablets, taken for breakthrough pain (surgeons occasionally prefer a different type of opioids such as hydrocodone, which is why we analyze the data using oral oxycodone equivalents). The pulsed shortwave devices will be removed by participants at home following Day 30 when the battery is exhausted (participants may remove them as early as Day 7, if they desire). Removing the devices encompasses tape removal and discarding in the trash (these are disposable, single-use devices).

Of note, if a device is reported lost or nonfunctional during the study, it will be replaced by the investigators by mail if more than 7 days of treatment remain.

Study outcomes: This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan. We will enroll convenience samples for each of the surgical procedures of up to 30 participants for each procedure, and anticipate analyzing each surgical procedure separately from the others. The two outcomes of primary interest will be (1) the "average" and "worst" pain measured with the Numeric Rating Scale (included in the Brief Pain Inventory pain domain), and (2) opioid consumption within the first 7 postoperative days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Pulsed Shortwave Treatment with BioElectronics Model 088

Device

Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088

Other names: nonthermal, pulsed shortwave (radiofrequency) therapy, pulsed electromagnetic fields therapy

Sham treatment

Device

Application of 7-30 days of a nonfunctional sham device(s)

Other names: Placebo treatment

Primary outcomes

  1. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale

  2. WORST Pain Measured With the Numeric Rating Scale

    Time frame: Mean value of the worst daily pain measured on postoperative days 1, 2, 3, and 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily worst pain scores measured with the Numeric Rating Scale

  3. Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents)

    Time frame: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7

    Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents).

Secondary outcomes

  1. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 1

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  2. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 2

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  3. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 3

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  4. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  5. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 14

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  6. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 21

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  7. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 28

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  8. AVERAGE Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 180

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  9. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 1

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  10. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 2

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  11. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 3

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  12. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  13. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 14

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  14. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 21

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  15. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 28

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  16. WORST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 180

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  17. LEAST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  18. LEAST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 14

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  19. LEAST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 21

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  20. LEAST Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 28

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  21. CURRENT Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 7

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  22. CURRENT Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 14

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  23. CURRENT Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 21

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  24. CURRENT Pain Measured With the Numeric Rating Scale

    Time frame: postoperative day 28

    The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.

  25. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 1

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  26. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 2

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  27. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 3

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  28. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 7

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  29. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 14

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  30. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 21

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  31. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 28

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  32. Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)

    Time frame: postoperative day 180

    Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)

  33. Brief Pain Inventory, Short Form (Interference Subscale)

    Time frame: postoperative day 7

    The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.

  34. Brief Pain Inventory, Short Form (Interference Subscale)

    Time frame: postoperative day 14

    The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.

  35. Brief Pain Inventory, Short Form (Interference Subscale)

    Time frame: postoperative day 21

    The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.

  36. Brief Pain Inventory, Short Form (Interference Subscale)

    Time frame: postoperative day 28

    The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.

  37. Awakenings Due to Pain

    Time frame: postoperative day 1

    The number of times the participant awoke the previous night due to pain

  38. Awakenings Due to Pain

    Time frame: postoperative day 2

    The number of times the participant awoke the previous night due to pain

  39. Awakenings Due to Pain

    Time frame: postoperative day 3

    The number of times the participant awoke the previous night due to pain

  40. Awakenings Due to Pain

    Time frame: postoperative day 7

    The number of times the participant awoke the previous night due to pain

  41. Awakenings Due to Pain

    Time frame: postoperative day 14

    The number of times the participant awoke the previous night due to pain

  42. Awakenings Due to Pain

    Time frame: postoperative day 21

    The number of times the participant awoke the previous night due to pain

  43. Awakenings Due to Pain

    Time frame: postoperative day 28

    The number of times the participant awoke the previous night due to pain

  44. Hospitalization Duration Measured in Days

    Time frame: One single measure recorded on or following the day of surgery (whichever day patient is discharged)

    Day relative to the day of surgery that patient was discharged from the hospital (e.g., same day is postoperative day 0, while the day following surgery is postoperative day 1) over the first postoperative week. The surgical service determines when patients are to be discharged using their own criteria which are not defined by the study.

  45. Passive Flexion (Knee and Hip Arthroplasty Patients Only)

    Time frame: One measure take at the two-week postoperative check (approximately postoperative day 14)

    The number of degrees of passive flexion achieved from a neutral position

  46. Day Stopped Using Intervention

    Time frame: One single measure recorded following the day of surgery

    Day relative to the day of surgery that patient stopped using the intervention for (e.g., same day is postoperative day 0, while the day following surgery is postoperative day 1)

  47. Desire Use of Device in Hypothetical Future Surgery?

    Time frame: queried on postoperative day 28

    Would the patient want to use the device for a hypothetical surgery in the future (yes, no, or undecided)?

  48. Surgical Start as Recorded Using Military Time Format

    Time frame: Intraoperative (within the operating room)

    The time of the surgical incision as recorded using military time format

  49. Surgical Stop as Recorded Using Military Time Format

    Time frame: Intraoperative (within the operating room)

    The time of the final suture insertion as recorded using military time format

  50. Surgical Duration

    Time frame: Intraoperative (within the operating room)

    The time from surgical start to surgical stop measured in minutes and hours

  51. Device Location Changes

    Time frame: Postoperative day 1

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  52. Device Location Changes

    Time frame: Postoperative day 2

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  53. Device Location Changes

    Time frame: Postoperative day 3

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  54. Device Location Changes

    Time frame: Postoperative day 7

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  55. Device Location Changes

    Time frame: Postoperative day 14

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  56. Device Location Changes

    Time frame: Postoperative day 21

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

  57. Device Location Changes

    Time frame: Postoperative day 28

    If a patient moves the anatomic location of one of the intervention devices since the last phone contact

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 1, 2022
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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