Postoperative Pain, AcuteNCT05399355
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
A study testing Active Pulsed Shortwave Treatment with BioElectronics Model 088 in people with Postoperative Pain, Acute, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Active Pulsed Shortwave Treatment with BioElectronics Model 088
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this 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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Active Pulsed Shortwave Treatment with BioElectronics Model 088, Sham Treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Pulsed Shortwave Treatment with BioElectronics Model 088Device
Also called nonthermal, pulsed shortwave (radiofrequency) therapy, pulsed electromagnetic fields therapy
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Sham TreatmentDevice
Also called Placebo treatment
Application of 7-30 days of a nonfunctional sham device(s)
| Study group | Role | What they receive |
|---|---|---|
| Active Pulsed Shortwave Treatment with BioElectronics Model 088 | Active comparator | Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088 Receives: Device: Active Pulsed Shortwave Treatment with BioElectronics Model 088 |
| Sham Treatment | Sham comparator | Application of 7-30 days of a nonfunctional sham device. Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
AVERAGE Pain Measured With the Numeric Rating Scale
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
Measured: Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7
WORST Pain Measured With the Numeric Rating Scale
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
Measured: Mean value of the worst daily pain measured 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)
Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents).
Measured: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7
Secondary outcomes (57)
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 1
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 2
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 3
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 7
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 14
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 21
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 28
AVERAGE Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 180
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 1
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 2
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 3
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 7
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 14
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 21
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 28
WORST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 180
LEAST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 7
LEAST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 14
LEAST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 21
LEAST Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 28
CURRENT Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 7
CURRENT Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 14
CURRENT Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 21
CURRENT Pain Measured With the Numeric Rating Scale
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Measured: postoperative day 28
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 1
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 2
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 3
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 7
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 14
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 21
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 28
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Measured: postoperative day 180
Brief Pain Inventory, Short Form (Interference Subscale)
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.
Measured: postoperative day 7
Brief Pain Inventory, Short Form (Interference Subscale)
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.
Measured: postoperative day 14
Brief Pain Inventory, Short Form (Interference Subscale)
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.
Measured: postoperative day 21
Brief Pain Inventory, Short Form (Interference Subscale)
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.
Measured: postoperative day 28
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 1
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 2
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 3
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 7
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 14
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 21
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Measured: postoperative day 28
Hospitalization Duration Measured in Days
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.
Measured: One single measure recorded on or following the day of surgery (whichever day patient is discharged)
Passive Flexion (Knee and Hip Arthroplasty Patients Only)
The number of degrees of passive flexion achieved from a neutral position
Measured: One measure take at the two-week postoperative check (approximately postoperative day 14)
Day Stopped Using Intervention
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)
Measured: One single measure recorded following the day of surgery
Desire Use of Device in Hypothetical Future Surgery?
Would the patient want to use the device for a hypothetical surgery in the future (yes, no, or undecided)?
Measured: queried on postoperative day 28
Surgical Start as Recorded Using Military Time Format
The time of the surgical incision as recorded using military time format
Measured: Intraoperative (within the operating room)
Surgical Stop as Recorded Using Military Time Format
The time of the final suture insertion as recorded using military time format
Measured: Intraoperative (within the operating room)
Surgical Duration
The time from surgical start to surgical stop measured in minutes and hours
Measured: Intraoperative (within the operating room)
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 1
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 2
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 3
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 7
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 14
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 21
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Measured: Postoperative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start18 Jul 2022
- Primary completion10 Oct 2023
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, MD, MS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399355
- Sponsor's protocol ID
- PEMF Surgical Pilot
- Status last verified
- Jul 2024
- First submitted
- 19 May 2022
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: per reasonable request and requiring a data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05399355
- Acronym / sponsor ID
- PEMF Surgical Pilot
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Active Pulsed Shortwave Treatment with BioElectronics Model 088 | Active comparator | Device: Active Pulsed Shortwave Treatment with BioElectronics Model 088Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088 |
| Sham Treatment | Sham comparator | Device: Sham TreatmentApplication of 7-30 days of a nonfunctional sham device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Pulsed Shortwave Treatment with BioElectronics Model 088Also: nonthermal, pulsed shortwave (radiofrequency) therapy, pulsed electromagnetic fields therapyApplication of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088 | Device | Active Pulsed Shortwave Treatment with BioElectronics Model 088 |
| Sham TreatmentAlso: Placebo treatmentApplication of 7-30 days of a nonfunctional sham device(s) | Device | Sham Treatment |
Primary outcome
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
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
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).
57 secondary outcomes
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 1
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 2
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 3
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 7
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 14
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 21
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 28
AVERAGE Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 180
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 1
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 2
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 3
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 7
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 14
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 21
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 28
WORST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 180
LEAST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 7
LEAST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 14
LEAST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 21
LEAST Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 28
CURRENT Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 7
CURRENT Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 14
CURRENT Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 21
CURRENT Pain Measured With the Numeric Rating Scale
Time frame: postoperative day 28
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)
Time frame: postoperative day 2
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)
Time frame: postoperative day 7
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)
Time frame: postoperative day 21
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)
Time frame: postoperative day 180
Brief Pain Inventory, Short Form (Interference Subscale)
Time frame: postoperative day 7
Brief Pain Inventory, Short Form (Interference Subscale)
Time frame: postoperative day 14
Brief Pain Inventory, Short Form (Interference Subscale)
Time frame: postoperative day 21
Brief Pain Inventory, Short Form (Interference Subscale)
Time frame: postoperative day 28
Awakenings Due to Pain
Time frame: postoperative day 1
Awakenings Due to Pain
Time frame: postoperative day 2
Awakenings Due to Pain
Time frame: postoperative day 3
Awakenings Due to Pain
Time frame: postoperative day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. per reasonable request and requiring a data sharing agreement
Related trials for Postoperative Pain, Acute
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M Ilfeld, MD, MS principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Pulsed Shortwave Treatment with BioElectronics Model 088 in people with Postoperative Pain, Acute, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.