Pulsed Electromagnetic Fields for Postoperative Analgesia... | NCT05399355

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Device: Active Pulsed Shortwave Treatment with BioElectronics Model 088
Sham Treatment	Sham Comparator	Application of 7-30 days of a nonfunctional sham device.	Device: Sham Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active Pulsed Shortwave Treatment with BioElectronics Model 088	Device	Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	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).	Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7

Secondary Outcomes

Measure	Description	Time Frame
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.	postoperative day 1
AVERAGE Pain Measured With the Numeric Rating Scale

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Brian M Ilfeld, MD, MS	University of California, San Diego	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego		San Diego	California	92103	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 8, 2022

Masking Info

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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)
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002.4± 1.6 OG0012.6± 1.7

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

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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).

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 1

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 2

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 3

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 180

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 1

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 2

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 3

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 180

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 1

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 2

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 3

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

postoperative day 180

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

score on a scale

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Secondary

Brief Pain Inventory, Short Form (Interference Subscale)

Posted

Mean

Standard Deviation

score on a scale

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Secondary

Brief Pain Inventory, Short Form (Interference Subscale)

Posted

Mean

Standard Deviation

score on a scale

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Secondary

Brief Pain Inventory, Short Form (Interference Subscale)

Posted

Mean

Standard Deviation

score on a scale

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 1

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 2

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 3

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Awakenings Due to Pain

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

Posted

Mean

Standard Deviation

events of awakening

postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

Secondary

Passive Flexion (Knee and Hip Arthroplasty Patients Only)

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

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

Posted

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

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)

Posted

Mean

Standard Deviation

Days

One single measure recorded following the day of surgery

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

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)?

The question regarding the desirability of device use in a hypothetical future surgery was inadvertently excluded from the case report forms.

Posted

queried on postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Surgical Start as Recorded Using Military Time Format

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

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.

Posted

Intraoperative (within the operating room)

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

Secondary

Surgical Stop as Recorded Using Military Time Format

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

Posted

Intraoperative (within the operating room)

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants

Secondary

Surgical Duration

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

Posted

Intraoperative (within the operating room)

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 1

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 2

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 3

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 7

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 14

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 21

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

Device Location Changes

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

Posted

Count of Participants

Participants

Postoperative day 28

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	59	0	59	0	59
EG001	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)	0	60	0	60	0	60

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms