Postoperative Pain, Acute
Conditions
Brief 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.
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.
Interventions
DEVICEActive Pulsed Shortwave Treatment with BioElectronics Model 088
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
DEVICESham Treatment
Application of 7-30 days of a nonfunctional sham device(s)
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
Intervention model description
Parallel Assignment: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients of at least 18 years of age undergoing one of these primary surgical procedures: 1. non-mastectomy breast surgery with a single-injection paravertebral nerve block 2. laparoscopic cholecystectomy 3. laparoscopic sleeve gastrectomy 4. percutaneous nephrolithotomy 5. ventral hernia repair 6. inguinal hernia repair 7. knee or hip arthroplasty 8. foot/ankle surgery with at least moderate pain anticipated 9. shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair) 10. hand/forearm/elbow surgery with at least moderate pain anticipated 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AVERAGE Pain Measured With the Numeric Rating Scale | 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 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| CURRENT Pain Measured With the Numeric Rating Scale | 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. |
| Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | postoperative day 1 | Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents) |
| Brief Pain Inventory, Short Form (Interference Subscale) | 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. |
| Awakenings Due to Pain | postoperative day 1 | The number of times the participant awoke the previous night due to pain |
| Hospitalization Duration Measured in Days | 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. |
| Passive Flexion (Knee and Hip Arthroplasty Patients Only) | 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 |
| AVERAGE Pain Measured With the Numeric Rating Scale | 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. |
| Desire Use of Device in Hypothetical Future Surgery? | queried on postoperative day 28 | Would the patient want to use the device for a hypothetical surgery in the future (yes, no, or undecided)? |
| Surgical Start as Recorded Using Military Time Format | Intraoperative (within the operating room) | The time of the surgical incision as recorded using military time format |
| Surgical Stop as Recorded Using Military Time Format | Intraoperative (within the operating room) | The time of the final suture insertion as recorded using military time format |
| Surgical Duration | Intraoperative (within the operating room) | The time from surgical start to surgical stop measured in minutes and hours |
| Device Location Changes | Postoperative day 1 | If a patient moves the anatomic location of one of the intervention devices since the last phone contact |
| Day Stopped Using Intervention | 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) |
| WORST Pain Measured With the Numeric Rating Scale | 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. |
| LEAST Pain Measured With the Numeric Rating Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088 | 59 |
| Sham Treatment Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s) | 60 |
| Total | 119 |
Baseline characteristics
| Characteristic | Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Sham Treatment | Total |
|---|---|---|---|
| Adductor Canal block | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 15 | 59 years STANDARD_DEVIATION 16 | 58 years STANDARD_DEVIATION 15 |
| Body Mass Index | 27 kg/m^2 STANDARD_DEVIATION 5 | 27 kg/m^2 STANDARD_DEVIATION 5 | 27 kg/m^2 STANDARD_DEVIATION 5 |
| Breast Surgery | 14 Participants | 15 Participants | 29 Participants |
| Cholecystectomy | 7 Participants | 6 Participants | 13 Participants |
| Erector spinal plane block | 0 Participants | 1 Participants | 1 Participants |
| Height | 170 cm STANDARD_DEVIATION 10 | 169 cm STANDARD_DEVIATION 10 | 169 cm STANDARD_DEVIATION 10 |
| Hernia | 8 Participants | 9 Participants | 17 Participants |
| Hip arthroplasty | 15 Participants | 15 Participants | 30 Participants |
| Knee arthroplasty | 15 Participants | 15 Participants | 30 Participants |
| No peripheral nerve block | 29 Participants | 27 Participants | 56 Participants |
| Paravertebral block | 14 Participants | 15 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Rectus sheath block | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 59 participants | 60 participants | 119 participants |
| Sex: Female, Male Female | 34 Participants | 44 Participants | 78 Participants |
| Sex: Female, Male Male | 25 Participants | 16 Participants | 41 Participants |
| Surgery duration | 86 minutes STANDARD_DEVIATION 29 | 93 minutes STANDARD_DEVIATION 39 | 89 minutes STANDARD_DEVIATION 34 |
| Transversus abdominis plane block | 0 Participants | 1 Participants | 1 Participants |
| Weight | 78 kg STANDARD_DEVIATION 19 | 79 kg STANDARD_DEVIATION 17 | 78 kg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
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
Time frame: Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 2.4 score on a scale | Standard Deviation 1.6 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 2.6 score on a scale | Standard Deviation 1.7 |
Primary
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).
Time frame: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents) | 21 mg | Standard Deviation 24 |
| Sham Treatment | Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents) | 17 mg | Standard Deviation 26 |
Primary
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
Time frame: Mean value of the worst daily pain measured on postoperative days 1, 2, 3, and 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 4.6 score on a scale | Standard Deviation 2 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 4.7 score on a scale | Standard Deviation 2.1 |
Secondary
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.
Time frame: postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 2.7 score on a scale | Standard Deviation 2 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 3.2 score on a scale | Standard Deviation 2 |
Secondary
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.
Time frame: postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 2.2 score on a scale | Standard Deviation 1.9 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 2.7 score on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 1.8 score on a scale | Standard Deviation 2 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 1.8 score on a scale | Standard Deviation 2.1 |
Secondary
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.
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 1.3 score on a scale | Standard Deviation 1.8 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 1 score on a scale | Standard Deviation 1.7 |
Secondary
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.
Time frame: postoperative day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 0 score on a scale | Standard Deviation 0 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | .1 score on a scale | Standard Deviation 0.5 |
Secondary
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.
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | .7 score on a scale | Standard Deviation 1.3 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | .7 score on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 1 score on a scale | Standard Deviation 1.8 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | .7 score on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | AVERAGE Pain Measured With the Numeric Rating Scale | 2.5 score on a scale | Standard Deviation 1.9 |
| Sham Treatment | AVERAGE Pain Measured With the Numeric Rating Scale | 2.9 score on a scale | Standard Deviation 2.1 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .4 events of awakening | Standard Deviation 1 |
| Sham Treatment | Awakenings Due to Pain | .3 events of awakening | Standard Deviation 0.6 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .5 events of awakening | Standard Deviation 1.2 |
| Sham Treatment | Awakenings Due to Pain | .2 events of awakening | Standard Deviation 0.6 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .4 events of awakening | Standard Deviation 1 |
| Sham Treatment | Awakenings Due to Pain | .4 events of awakening | Standard Deviation 0.9 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .4 events of awakening | Standard Deviation 1.2 |
| Sham Treatment | Awakenings Due to Pain | .1 events of awakening | Standard Deviation 0.4 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .8 events of awakening | Standard Deviation 1.7 |
| Sham Treatment | Awakenings Due to Pain | .2 events of awakening | Standard Deviation 0.7 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .7 events of awakening | Standard Deviation 1.7 |
| Sham Treatment | Awakenings Due to Pain | .5 events of awakening | Standard Deviation 0.9 |
Secondary
Awakenings Due to Pain
The number of times the participant awoke the previous night due to pain
Time frame: postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Awakenings Due to Pain | .8 events of awakening | Standard Deviation 1.9 |
| Sham Treatment | Awakenings Due to Pain | .6 events of awakening | Standard Deviation 1.4 |
Secondary
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.
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Brief Pain Inventory, Short Form (Interference Subscale) | .6 score on a scale | Standard Deviation 1.5 |
| Sham Treatment | Brief Pain Inventory, Short Form (Interference Subscale) | .3 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Brief Pain Inventory, Short Form (Interference Subscale) | 1.1 score on a scale | Standard Deviation 2.3 |
| Sham Treatment | Brief Pain Inventory, Short Form (Interference Subscale) | .6 score on a scale | Standard Deviation 1.5 |
Secondary
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.
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Brief Pain Inventory, Short Form (Interference Subscale) | 1.7 score on a scale | Standard Deviation 2.7 |
| Sham Treatment | Brief Pain Inventory, Short Form (Interference Subscale) | 1.1 score on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Brief Pain Inventory, Short Form (Interference Subscale) | 2.7 score on a scale | Standard Deviation 3.1 |
| Sham Treatment | Brief Pain Inventory, Short Form (Interference Subscale) | 1.8 score on a scale | Standard Deviation 2.8 |
Secondary
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.
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | CURRENT Pain Measured With the Numeric Rating Scale | 1.1 score on a scale | Standard Deviation 1.8 |
| Sham Treatment | CURRENT Pain Measured With the Numeric Rating Scale | .8 score on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | CURRENT Pain Measured With the Numeric Rating Scale | .5 score on a scale | Standard Deviation 1 |
| Sham Treatment | CURRENT Pain Measured With the Numeric Rating Scale | .4 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | CURRENT Pain Measured With the Numeric Rating Scale | 1.6 score on a scale | Standard Deviation 1.9 |
| Sham Treatment | CURRENT Pain Measured With the Numeric Rating Scale | 1.4 score on a scale | Standard Deviation 2.2 |
Secondary
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.
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | CURRENT Pain Measured With the Numeric Rating Scale | .7 score on a scale | Standard Deviation 1.5 |
| Sham Treatment | CURRENT Pain Measured With the Numeric Rating Scale | .5 score on a scale | Standard Deviation 1.3 |
Secondary
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)
Time frame: One single measure recorded following the day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Day Stopped Using Intervention | 21.3 Days | Standard Deviation 7.8 |
| Sham Treatment | Day Stopped Using Intervention | 23.4 Days | Standard Deviation 7.9 |
Secondary
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)?
Time frame: queried on postoperative day 28
Population: The question regarding the desirability of device use in a hypothetical future surgery was inadvertently excluded from the case report forms.
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 6 Participants |
| Sham Treatment | Device Location Changes | 3 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 6 Participants |
| Sham Treatment | Device Location Changes | 3 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 0 Participants |
| Sham Treatment | Device Location Changes | 0 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 0 Participants |
| Sham Treatment | Device Location Changes | 0 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 0 Participants |
| Sham Treatment | Device Location Changes | 0 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 0 Participants |
| Sham Treatment | Device Location Changes | 0 Participants |
Secondary
Device Location Changes
If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Time frame: Postoperative day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Device Location Changes | 0 Participants |
| Sham Treatment | Device Location Changes | 0 Participants |
Secondary
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.
Time frame: One single measure recorded on or following the day of surgery (whichever day patient is discharged)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Hospitalization Duration Measured in Days | .3 Days | Standard Deviation 0.5 |
| Sham Treatment | Hospitalization Duration Measured in Days | .3 Days | Standard Deviation 0.5 |
Secondary
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.
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | LEAST Pain Measured With the Numeric Rating Scale | .6 score on a scale | Standard Deviation 1.2 |
| Sham Treatment | LEAST Pain Measured With the Numeric Rating Scale | .4 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | LEAST Pain Measured With the Numeric Rating Scale | .7 score on a scale | Standard Deviation 1.6 |
| Sham Treatment | LEAST Pain Measured With the Numeric Rating Scale | .9 score on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | LEAST Pain Measured With the Numeric Rating Scale | .3 score on a scale | Standard Deviation 0.8 |
| Sham Treatment | LEAST Pain Measured With the Numeric Rating Scale | .2 score on a scale | Standard Deviation 0.8 |
Secondary
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.
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | LEAST Pain Measured With the Numeric Rating Scale | .5 score on a scale | Standard Deviation 1.2 |
| Sham Treatment | LEAST Pain Measured With the Numeric Rating Scale | .3 score on a scale | Standard Deviation 1.1 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1.1 mg | Standard Deviation 1.8 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1.1 mg | Standard Deviation 2.2 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1.4 mg | Standard Deviation 1.7 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1 mg | Standard Deviation 1.4 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1.3 mg | Standard Deviation 1.7 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 1 mg | Standard Deviation 1.3 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 0 mg | Standard Deviation 0 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | 0 mg | Standard Deviation 0 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .2 mg | Standard Deviation 0.9 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .1 mg | Standard Deviation 0.4 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .1 mg | Standard Deviation 0.4 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .2 mg | Standard Deviation 0.7 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .4 mg | Standard Deviation 0.9 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .3 mg | Standard Deviation 0.9 |
Secondary
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .5 mg | Standard Deviation 0.9 |
| Sham Treatment | Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents) | .7 mg | Standard Deviation 1.5 |
Secondary
Passive Flexion (Knee and Hip Arthroplasty Patients Only)
The number of degrees of passive flexion achieved from a neutral position
Time frame: One measure take at the two-week postoperative check (approximately postoperative day 14)
Population: This data point was not able to be collected as participants did not return to the surgeon's office for measurement at 14 days as originally anticipated
Secondary
Surgical Duration
The time from surgical start to surgical stop measured in minutes and hours
Time frame: Intraoperative (within the operating room)
Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
Secondary
Surgical Start as Recorded Using Military Time Format
The time of the surgical incision as recorded using military time format
Time frame: Intraoperative (within the operating room)
Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
Secondary
Surgical Stop as Recorded Using Military Time Format
The time of the final suture insertion as recorded using military time format
Time frame: Intraoperative (within the operating room)
Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
Secondary
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.
Time frame: postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 5.1 score on a scale | Standard Deviation 2.1 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 5.6 score on a scale | Standard Deviation 2.4 |
Secondary
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.
Time frame: postoperative day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 1.6 score on a scale | Standard Deviation 2.4 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 1.4 score on a scale | Standard Deviation 2 |
Secondary
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.
Time frame: postoperative day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 2.5 score on a scale | Standard Deviation 2.6 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 1.9 score on a scale | Standard Deviation 2.2 |
Secondary
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.
Time frame: postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 4.3 score on a scale | Standard Deviation 2.7 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 4.6 score on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 3.6 score on a scale | Standard Deviation 2.6 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 3.3 score on a scale | Standard Deviation 2.9 |
Secondary
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.
Time frame: postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 5.2 score on a scale | Standard Deviation 2.4 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 5.7 score on a scale | Standard Deviation 2.6 |
Secondary
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.
Time frame: postoperative day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | .3 score on a scale | Standard Deviation 1.1 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | .4 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: postoperative day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Pulsed Shortwave Treatment With BioElectronics Model 088 | WORST Pain Measured With the Numeric Rating Scale | 1.3 score on a scale | Standard Deviation 2.1 |
| Sham Treatment | WORST Pain Measured With the Numeric Rating Scale | 1.2 score on a scale | Standard Deviation 1.9 |