Frequency Specific Microcurrent for the Treatment of Diastasis Recti
Phase: NA
Conditions: Diastasis Recti
Sponsor: Diana Trang

Frequency Specific Microcurrent for the Treatment of Diastasis Recti
NCT04060563
Doc Date: 3/2/2021

EIRB Protocol Template (Version 1.14)
1.0
General Information
*Please enter the full title of your study:
Frequency Specific Microcurrent for the treatment of diastasis recti
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
FWH20190124H
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
 
 
Does this protocol involve the use of animals?
Yes
No
 
 
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
USAF - 99 MDG/MOFMC
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Trang, Diana T, DO, BS
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Adams, Shalease S 
 Associate Investigator
Crawford, Paul F 
 Associate Investigator
N

Hughes, Pamela Rae, MD 
 Associate Investigator
Moss, David 
 Associate Investigator
B) Research Support Staff
Bogdanovich, Tracy Lee 
 Research Coordinator
Clark, Jill Marie, MBA/HCM 
 Research Coordinator
Crawford, Amanda J 
 Participating Clinician
Crawford, Kristy J, BSN 
 Team Member
Huffman, Sandra G 
 Research Coordinator
Moss, Jennie B 
 Research Coordinator
Shaffer, Daniel WILLIAM 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Clark, Jill Marie, MBA/HCM 
Huffman, Sandra G 
Trang, Diana T, DO, BS 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  * Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
If Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
4.2  * Is this a research study or a Compassionate Use/Emergency Use/HUD project?
 Yes   
 No

4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
4.4  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.6  * Is this human subjects research? (As defined by 32 CFR 219) 
 
Human subject means a living individual about whom an investigator (whether professional or 
student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, 
and uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  * Do you believe this human subjects research is exempt from IRB review?
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the 
protocol:
Name:
(Last, First, M.I.)
Tate, Rachel
Role on Protocol:
Research Technician
Phone Number:
 
(702) 653-3298
Email Address:
 
r.tate.ota@gmail.com
Associated Institution:
 
99 MDG/Nellis AFB
Name:
(Last, First, M.I.)
Estrada, Jonica
Role on Protocol:
Research Coordinator
Phone Number:
 
(702) 653-2975
Email Address:
 
jonica.estrada.
ctr@mail.mil
Associated Institution:
 
99 MDG/Nellis AFB
Name:
(Last, First, M.I.)
Haney, Thomas
Phone Number:
 
(702) 653-3902
Email Address:
 
thaney@axiom-rm.
Associated Institution:
 
99 MDG/Nellis AFB

Role on Protocol:
Research Coordinator
com
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
: Other
Air Force Medical Support 
Agency
:
Research Development 
Testing and Evaluation 
(RDT&E) funds
595000
Total amount of funding:
595000
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes   
  No
8.2  Study Facilities and Locations:

Institution
Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
Air Force
99MDG
Performance 
site
F50417
10/31/2020
: IAIR
:
WHASC 
IRB 
Protocol 
Office
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local research 
context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to study 
approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Family Medicine Residency, Family Medicine
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the protocol.  The 
background section should clearly support the choice of study variables and explain the basis for the 
research questions and/or study hypotheses.  This section establishes the relevance of the study and 
explains the applicability of its findings
Diastasis rectus abdominus (DRA) is a common finding among pregnant and postpartum women (3,6). A 
small number of studies have shown a correlation between DRA and reduced abdominal wall functioning 
and poor overall body image (5, 6); some studies have shown DRA to be associated with lumbopelvic 
pain (3). A study evaluating natural recovery of DRA after pregnancy showed some improvement in DRA 
and abdominal wall function compared to baseline, but did not return to baseline levels (6). DRA-specific 
exercise protocols have not been consistently effective in improving associated lumbopelvic pain and it is 

unclear if abdominal functionality is improved (1, 2, 6). Ultrasound can be used to noninvasively and 
accurately measure DRA (3, 4, 5, 7). With general therapy, microcurrent treatments have been shown to 
improve muscle function and may reduce pain associated with muscular dysfunction, however no studies 
that we are aware of are using microcurrent to treat DRA. We wish to determine if frequency specific 
microcurrent treatment is an effective treatment for DRA. Secondarily we will assess lumbar and/or 
pelvic pain levels, urogynecologic symptoms, and overall body image after having microcurrent therapy. 
The significance of improving DRA in the postpartum military population may be that the service member 
can return to exercise sooner without pain and have improved strength, thereby allowing her to return to 
duty and meet military fitness standards
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses
Determine if frequency specific microcurrent therapy improves pain management of DRA by 30% or 
greater
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, cohort, etc.). 
Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug research
Active duty or DoD beneficiary post-partum females aged 18 years or older who have met inclusion
/exclusion criteria and are willing to participate in a randomized double-blind study assessing a 
microcurrent therapy treatment vs placebo (a microcurrent faux (fake) treatment) over a 12-week period 
post-partum. They will be recruited from the post-partum unit at 99MDG (see section 13.1).
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active duty or DoD beneficiary females aged 18 years or older who are postpartum from a singleton 
gestation status post vaginal, who meet the inclusion and exclusion criteria will be recruited.  No special 
populations (i.e. pregnant women, children, military basic trainees, prisoners, detainees) will be recruited.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Improving pain management of DRA after microcurrent therapy in post-partum females may allow a 
faster, more effective return to activity, the return-to-duty transition and establishing personal readiness 
by meeting military fitness standards
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end

Female Active duty members or DoD beneficiaries, aged 18 years or older, meeting the inclusion
/exclusion criteria will be offered an opportunity to participate. They will be recruited from the 
postpartum unit at 99MDG (see Protocol Section 13.1). All of the below items are research-related unless 
marked as ‘standard of care’:
Pre-Eligibility review: Subjects who responded to advertisements or have given their permission to be 
contacted will be approached by a study staff member to discuss the subject’s interest in the research 
study and to receive a pre-eligibility screening for study participation. The attached “Pre-
Eligibility Review Script” will be used and response will be recorded. If the subject is interested in 
participating in the study, the study staff member will schedule a screening visit while the subject waits 
on the phone or in-person, in order to confirm the schedule appointment with the subject.
Following the pre-screening procedure, the script will be shredded.
Screening visit (within 3 months postpartum): 
-Obtain and document signed Informed Consent and HIPAA authorization.
-Review past medical and pregnancy history to verify inclusion and exclusion criteria.
-Collect demographic information to include age, weight (pounds), height (inches), BMI, DoD ID#, 
current email address (for scheduling), phone number, race, ethnicity.
 Subjects will be randomized into one of two research treatment groups with 
Randomization:
approximately 58 subjects in each arm:
-Group 1: Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning 
the microcurrent box on placebo mode ), for one treatment lasting a total of 7 hours and 10 minutes the 
device will worn at home and returned.
Group 2: Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti 
Repair protocol (8), for one treatment lasting a total of 7 hours and 10 minutes the device will be worn 
at home and returned.
 
Blinding: Amanda Crawford will be responsible for managing the excel spreadsheet that randomly 
assigns the patient to Group 1 or Group 2. She will place the randomization code into a sealed envelope 
and deliver it to the Research Technicians who will program the microcurrent boxes to either Group 1 
(Sham microcurrent therapy) or Group 2 (microcurrent therapy). The blinded microcurrent boxes will 
them be provided to the study staff to apply the microcurrent treatment. The remaining study staff will 
be blinded to the study treatment. If at any time a patient experiences and adverse event that requires 
breaking of the blind, Amanda can provide the randomization assignment. At the conclusion of the study, 
and once all the subjects have completed treatment and follow up, Amanda will provide the 
randomization assignments to the study staff to be included in the data analysis.

Visit 1 (may be the same day as screening visit):
- We will apply ultrasound gel and measure inter-rectus distance (IRD), 2 cm above and 2 cm below the 
umbilical ring, via ultrasound or if unable via ultrasound, via palpation and measuring tape.
-Begin treatment according to randomization group, patients will be instructed to leave microcurrent in 
place until treatment is over. Subjects will return to the clinic the day after visit 1 so that Reserch 
personnel can retrieve the microcurrent box. We will apply ultrasound gel and measure inter-rectus 
distance (IRD), 2 cm above and 2 cm below the umbilical ring, via ultrasound or palpation with tape 
measure (measurement will be the same technique as the original measurement.
Visit 2/week 2 (between 2 weeks and 4 weeks):
- We will apply ultrasound gel and measure inter-rectus distance (IRD), 2 cm above and 2 cm below the 
umbilical ring, via ultrasound or palpation with tape measure (measurement will be same technique as 
original measurement)
Visit 3/week 4-12 (between week 4 and 12):
- We will apply ultrasound gel and measure inter-rectus distance (IRD), 2 cm above and 2 cm below the 
umbilical ring, via ultrasound or palpation with tape measure (measurement will be same technique as 
original measurement)
-Administer Body Image States Scale (BISS) (5 minutes)
-Administer Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7) (5 minutes)
-Obtain Defense and Veterans Pain Rating Scale for lumbar pain and pelvic pain (DVPRS) (5 minutes)
 
: We will be using the Inspirstar microcurrent stimulator TENS device. 
Microcurrent Device
It is an FDA 
510k approved portable hand-held device used for the symptomatic relief of chronic pain. It generates 
20µA to 400µA.For this study, we will use a treatment range 
low current intensity pulses in the ranges of 
of 100-300µA.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the data will 
be operationally measured.
-Variables: Age, parity, pregnancy weight-gain (from medical record), BMI
-Information to be collected:  Demographics (age, weight, height, BMI, parity, medical and pregnancy 
history, assessments (pain, body image, strength, urogynecologic symptoms)
-Source of data:  Patient
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific aims, 
and/or research hypotheses.  Explain how missing data and outliers will be handled in the analysis.  The 
analysis plan should be consistent with the study objectives.  Include any sub-group analyses (e.g., 
gender or age group).  Specify statistical methods and variables for each analysis.  Describe how 
confounding variables will be controlled in the data analysis

The primary outcome measures are inter-rectus distances (IRD) taken 2 cm above and 2 cm below the 
umbilical ring. Secondary outcome measures taken once at the final postpartum visit between weeks 4 
and 12 are Body Image States Scale (BISS); Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7); 
and Defense and Veterans Pain Rating Scale for lumbar pain and pelvic pain (DVPRS). Employing these 
outcome measures, the statistical null hypotheses are as follows:
H01 — there are no differences in IRD means between times, locations and treatment groups
H02 — there are no differences in BISS means between treatment groups
H03 — there are no differences in PFIQ-7 means between treatment groups
H04 — there are no differences in DVPRS means between treatment groups
11.2  Sample Size:
Planned to Enroll: 116
Planned to Complete: 98
11.3  Total number of subjects requested (including records and specimens):
116
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
Randomization: Subjects will be randomized into one of two research treatment groups with 
approximately 58 subjects in each arm:
-Group 1: Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning 
the microcurrent box on placebo mode ), for one treatment lasting a total of 7 hours and 10 minutes the 
device will be worn at home and returned. Group 2: Frequency specific microcurrent therapy (100-300μA 
microccurrent amps) with Diastasis Recti Repair protocol (8), for one treatment lasting a total of 7 hours 
and 10 minutes the device will be worn at home and returned.
11.5  Please provide a justification for your sample size
Subjects will be a random sample of patients meeting the inclusion criteria. Subjects are presumed to be 
a random representation of the population of patients obtaining similar care at this and other Air Force 
medical treatment facilities. The main treatment effect is treatment using microcurrent electrical 
neuromuscular stimulation. Group 1 will receive a placebo effect and Group 2 will receive the treatment 
effect.
The study is organized as a mixed effects, randomized complete block design with repeated measures. 
Subject is a random effect as subjects will have been randomly subject to DRA from the population of 
patients obtaining similar care at these Air Force medical treatment facilities, randomly enrolled from this 
population of patients, and randomly assigned to treatment groups at the time of enrollment. Fixed 
effects are treatment group, time of repeated measure, and IRD location as these effects cannot be 
generalized to other treatments, times or locations. 
A priori power was assessed using G*Power Version 3.1.9.3. (9) The researchers wish to detect at least a 
30% difference in IRD between the treatment groups. The mean (SD) IRD at the four locations at 7 
weeks postpartum has been estimated to be 1.97 (0.71) cm, 2.39 (0.59) cm, 1.99 (0.65) cm, and 1.30 
(0.77) cm respectively, and the minimally detectable changes at a 95% confidence level to be 0.45 cm, 
0.47 cm, 0.55 cm and 0.36 cm respectively. (10) These are smaller differences, but near the stated 
research objective; therefore, these will be used as a conservative effect size to estimate a priori power. 
The results indicate 98 subjects with 3 repeated measures will have a power of 0.801 at α = 0.05 to 
detect these minimally detectable differences between the treatment groups.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
Means, standard deviations, medians, interquartile ranges (IQR) and ranges will be calculated for interval 
variables. These variables include patient characteristics and physiological measurements such as age, 
weight, height, BMI, and pregnancy weight gain. Frequency distributions will be calculated for nominal 
variables that include race/ethnicity, and parity.

Null hypothesis H01 will be tested by a mixed effects repeated measures analysis of variance (rANOVA) 
controlling for location and treatment group. In the event the null hypothesis is rejected, contrasts will 
be used to investigate sub-group differences. The significance level of multiple comparison tests will be 
corrected to α = .05 by the Holm method. (11) Null hypotheses H02 to H04 will be tested with a two 
sample t-test or Mann-Whitney U test depending on whether the data is distributed normally or non-
normally.  
Mr. Danny Sharon, Senior Research Biostatistician Subject Matter Expert for Clinical Research 
Management under contracts OMNI 0004 3-82 and OMNI 0005 3-126, is the statistical consultant 
supporting this study. Statistical analysis will be performed with R Version 3.5.1. (12)
12.0
 
Participant Information
12.1  Subject Population:
Active duty or DoD beneficiary post-partum females aged 18 or older, meeting the inclusion and 
exclusion criteria will be recruited.   No special populations be recruited.
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does not 
match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners

Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
-Active Duty and DoD beneficiary Postpartum Females (within 3 months postpartum) with 
Diastasis Rectus Abdominus (DRA) pain
-IRD greater than or equal to 2.5 cm
-Aged 18 years or older
-Singleton gestation/delivered (one baby carried and born)
-Vaginal delivery
-Nulliparous (first pregnancy) or multiparous (more than one pregnancy in the past)
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
-less than 18 years of age
-females greater than 3 months post-partum
-Medical history to include pacemaker
-History of arrhythmia
-Transplant status
-Insulin pump
-Pain pump
-Active cancer
-IRD less than 2.5 cm
-Inability to measure IRD
-Delivery via caesarean section
-Operative vaginal delivery (vacuum or forceps)
-3
 or 4
 degree vaginal laceration
rd
th
 
- Inability to return the microcurrent device
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.

All potentially eligible patients will be offered an opportunity to participate. Labor and Delivery staff 
referrals, with the patient’s oral or written authorization, will be utilized for recruiting subjects to the 
study. Some patients may be patients of the PI or AI; however, they will have another study staff recruit 
their patients to prevent any misconception of coercion or undue influence. When a potential subject is 
identified by the Labor and Delivery staff , the patient will either be provided a contact number to the 
Research Staff, the Research Staff will be given the potential subjects’ contact information by the Labor 
and Delivery staff, or the Research Staff will speak with the patients directly. The patients will then be 
given a copy of the advertisement and told that they will be contacted at a later date to see if they are 
still interested in participating.
13.2  Compensation for Participation:
Subjects will not be paid for their participation.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text 
editor
Pre-Eligibility review: Subjects who have given their permission to be contacted will be approached by a 
study staff member to discuss the subjects’ interest in the research study and to receive a pre-eligibility 
screening for study participation. The attached “Pre-Eligibility Review Script” will be used and response 
will be recorded. If the subject is interested in participating in the study, the study staff member will 
schedule a screening visit while the subject waits on the phone or in-person, in order to confirm the 
schedule appointment with the subject. Following the pre-screening procedure, the script will be 
shredded.
13.4  Consent Process:
 
Revised Common Rule, Section 219.116:  General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the 
requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be 
obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this 
section only with respect to the storage, maintenance, and secondary research uses of identifiable 
private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Informed Consent and HIPAA authorization will be sought in advance of any screening and study-related 
procedures from each prospective study subject and appropriately documented in accordance with 32 
CFR 219.117. Potential candidates will be notified about the study by their healthcare provider and will 
be given the opportunity to consent by one of the referred study coordinators. The study coordinator will 
provide a written copy of the Informed Consent Document (ICD). The subject may decline to consent 
without prejudice. At the subjects’ discretion, they may take the ICD home to discuss further with family 
members or another physician prior to making a decision. If they decide they are interested in 
participating in the study, they can contact the research department. If the subject consents, a copy of 
the signed ICD and HIPAA Authorization Document will be given to the subject. No vulnerable 
populations are included in this research study. Subjects who cannot provide Informed Consent will not 
be allowed to participate. No Legally Authorized Representatives (LAR) will be utilized. Each subject will 
be asked to place their de-identified research data into the “Mike O'Callaghan Military Medical Center 
General Research Data Repository” (FWH20180064H) for future research. If the subject does not give 
their authorization, then the de-identified research data will be destroyed no later than at 3 years after 
closure of the study.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 

13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the opportunity 
to withdraw their data their data/specimens in the event they wish to withdraw from the study
If a participant first agrees to participate and then changes their mind, they are free to withdraw consent 
and discontinue participation at any time. Their decision will not affect their ability to receive medical 
care and will not be penalized or lose any benefits to which they would otherwise be entitled. There are 
no risks from withdrawing. They will be advised in the Informed Consent process that if they decide to 
withdraw from the study early, we will ask them to discuss their decision with the study staff. The 
researcher may withdraw them from the study prior to the study’s end without their consent for one or 
more of the following reasons: Failure to follow the instructions of the researchers and study staff. The 
researcher decides that continuing their participation is not in their best interests. The study is cancelled. 
Other administrative reasons. Unanticipated circumstances. They become Pregnant. If they lose their 
status as a military health care beneficiary, they can no longer be included in the study.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach of 
confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do not describe 
risks from standard care procedures; only describe risks from procedures done for research purposes
There may be a risk of an accidental breach of confidentiality. The potential risks to participate in this 
study are minimal, although there may be risks currently unknown. The risks associated with 
participating in this research study include:
 
Less Likely and Not Serious:
Ultrasound:
-Skin sensitivity or allergic reaction to gel
-Discomfort with ultrasound exam
 
Microcurrent:
-Discomfort with microcurrent treatment
-Skin sensitivity after treatment
-Skin damage
-Conditions may worsen
-Nausea
-If the device malfunctions, it could give an inadvertent electrical shock similar to a mosquito bite
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate risk of 
harms to subjects and study personnel
Safeguards are in place for protecting subjects and their health data. The research consents and HIPAA 
Authorization Documents will be stored in a locked cabinet in a locked room. Safeguards are in place for 
protecting subjects. Risks related to the microcurrent will be minimized by proper use of the microcurrent 
device. Proper use includes software and firmware updates, cleaning pads after each patient, and daily 
inspection of cables. Subjects do not have to participate or answer any question that they do not want to 

complete. If at any time the patient reports a side effect, they will be referred to one of the Investigators 
for care.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and records 
throughout the study and at its conclusion (e.g., destruction, long term storage, or banking). Explain the 
plan for securing the data (e.g., use of passwords, encryption, secure servers, firewalls, and other 
appropriate methods). If data will be shared electronically with other team members/collaborators 
outside the institution, describe the method of transmission and safeguards to maintain confidentiality. 
Explain whether this study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action, e.g., child or spouse abuse
Safeguards for Protecting Information:  The research consents and HIPAA Authorization Documents will 
be stored in a locked cabinet in a locked room with restricted access. All identifiable research data 
including patient demographics will be kept in an electronic database separate from the coded research 
data, which will be encrypted, double password protected and the access will be restricted. Based on AFI 
33-332, “The Air Force Privacy and Civil Liberties Program” and the National Institute of Standards and 
Technology Special Publication (NIST SP 800-88) which outlines the approved methods to destroy PII: 
The research data will be coded and any links to identifiable data (i.e., Master Key) will be destroyed as 
soon as all data mergers have occurred or no later than at the closure of the study. The anonymized 
research data will not be utilized for further research activity beyond the protocol stipulations without 
additional IRB approval. At the conclusion of the study, the data will be de-identified prior to review and 
analysis. Paper data, including completed consent forms: The research consents and HIPAA Authorization 
Documents will be stored in a locked cabinet in a locked room with restricted access.
Electronic data: Medical records will be annotated with ICD-10 code Z00.6 to reflect the subjects’ 
participation in a research study, in which they are receiving a research-related treatment intervention. 
All research data that includes the Master Key of identifiable patient demographics and PHI/PII will be 
kept in an electronic database, separate from the coded research data, which will be encrypted, 
password protected and the access will be restricted.
Long-term storage (following completion of the study and inactivation of IRB approval): The research 
data will be coded and any links to identifiable data will be destroyed (in approved shredding bin) as 
soon as possible or no later than at the closure of the study, with the exception of those study subjects 
that consent to place their de-identified research data into the “Mike O'Callaghan Military Medical Center 
General Research Data Repository” (FWH20180064H) for future research. The anonymized research data 
will not be utilized for further research activity beyond the protocol stipulations without additional IRB 
approval. All de-identified research data will be maintained for 3 years following study closure. No data 
transfers to the repository will occur until the protocol has been officially closed and the Master Key of 
identifiable PHI/PII and codes has been destroyed.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits to a 
specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and they 
cannot provide their own consent, the protocol must describe the intent to directly benefit all subjects
Subjects may experience an improvement in diastasis rectus abdominus (DRA), improvement in 
abdominal wall functionality, reduction of pain, improvement in body image, improvement in 
urogynecologic symptoms; however, this is not a guarantee.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and all 
research activities, etc.

Records of participation in this study may only be disclosed in accordance with Federal law, including the 
Federal Privacy Act, 5 U.S.C. § 552a, the Health Insurance Portability & Accountability Act of 1996, Public 
Law 104-109 (also known as HIPAA), and their implementing regulations. DD Form 2005, Privacy Act 
Statement- Military Health Records, contains the Privacy Act Statement for the records. The Informed 
Consent gives permission for information gained from participants in this study to be published in 
medical literature, discussed for educational purposes, and used generally to further the generalizable 
knowledge of the medical science community. They will not be personally identified; all information will 
be presented as anonymous data. We will annotate their medical record to reflect their participation in a 
research study for each visit because this study involves an intervention that is for research purposes 
only. A copy of this consent will be stored by the investigator in a locked cabinet in a locked room, as 
part of the research record. All research data will be kept in an electronic database, which will be double 
password protected, firewall-protected, encrypted, and access-restricted to people involved in this study. 
The research data will be coded. As soon as possible, any link between identity and the research 
information will be destroyed which means research information about the participant will be 
permanently de-identified. Personal identifying information will be destroyed no later than at the closure 
of the study. The research information collected for this study will not be used for any additional research 
activity beyond what was approved in the signed consent. In the unlikely event that a loss of 
confidentiality occurs, the study staff will advise the subjects to contact their local privacy office for 
assistance. Complete confidentiality cannot be promised, particularly for military personnel, because 
information regarding potential UCMJ violations or concerns regarding fitness for duty may be reported to 
appropriate medical, law enforcement, or command authorities.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject could 
possibly benefit medically or otherwise from the information, state whether or not the results of 
screening, research participation, research tests, etc., will be shared with subjects or their primary care 
provider. State whether the researcher is obligated or mandated to report results to appropriate military 
or civilian authorities and explain the potential impact on the subject
If significant new findings develop during the course of this study that may relate to subjects’ decision to 
continue to participate in the study, they will be informed
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met

 
• Describe plans for reporting expected adverse events. Identify what the expected adverse events will 
be for this study, describe the likelihood (frequency, severity, reversibility, short-term management and 
any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address how 
unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event
Events will be reported in accordance with 59MDW IRB policies and procedures.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in accordance 
to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
INSPIRSTAR IS02 MICROCURRENT STIMULATOR 
Manufacturer/Supplier of Device
INSPIRSTAR, INC. 
Where will the Devices Be Stored
Stored in the clinic with all the other supplies. 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
The device is lawfully marketed in the U.S. The device has been 
published in the federal register under 510k# K060368. 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.
cfm?ID=K060368  

18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event reporting and 
adverse device effects reporting to the sponsor
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:

1. Benjamin, D., van de Water, A., & Peiris, C. (2014). Effects of exercise on diastasis of the rectus 
abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy, 1-8.
2. Chiarello, C., McAuley, J., & Hartigan, E. (2016). Immediate Effect of Active Abdominal Contraction on 
Inter-recti Distance. Journal of Orthopedics Sports Physical Therapy, 177-183.
3. Fernandes da Mota, P., Pascoal, A., Cartia, A., & Bo, K. (2015). Prevalence and risk factors of diastasis 
recti abdominis from late pregnancy to 6 months postpartum, and relationship with lumbo-pelvic pain. 
Manual Therapy, 200-205.
4. Keshwani, N., Mathur, S., & McLean, L. (2015). Validity of Inter-rectus Distance Measurement in 
Postpartum Women Using Extended Field-of-View Ultrasound Imaging Techniques. Journal of Orthpedic 
Sports Physical Therapy, 808-813.
5. Keshwani, N., Mathur, S., & McLean, L. (2018). Relationship Between Interrectus Distance and 
Symptom Severity in Women With Diastasis Recti Abdominis in the Early Postpartum Period. Journal of 
Physical Therapy, 182-190.
6. Liaw, L., Hsu, M., Liao, C., & Hsu, A. (2011). The relationships between inter-recti distance measured 
by ultrasound imaging and abdominal muscle function in postpartum women: a 6-month follow-up study. 
Journal of Orthopedic Sports Physical Therapy, 435-443.
7. Sancho, M., Pascoal, A., Mota, P., & Bo, K. (2015). Abdominal exercises affect inter-rectus distance in 
postpartum women: a two-dimensional ultrasound study. Physiotherapy, 286-291.
8. Goossen, S., Demitry, P. (2018) Frequencies for Physical Therapy.
9. Faul F, Erdfelder E, Lang A-G, Buchner A. G*Power 3: A flexible statistical power analysis program for 
the social, behavioral, and biomedical sciences. Behavior Research Methods. 2007; 39 (2): 175-191.
10. Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT. The Relationships Between Inter-recti Distance Measured 
by Ultrasound Imaging and Abdominal Muscle Function in Postpartum Women: A 6-Month Follow-up 
Study. J of Ortho & Sports Phy Ther. 2011; 41(6):435-443.
11. Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
12. R Core Team (2014). R: A language and environment for statistical computing. R Foundation for 
Statistical Computing, Vienna, Austria. URL Caution-http://www.R- < Caution-http://www.R- > project.
org/ < Caution-http://project.org/ > .
20.2  Abbreviations and Acronyms:
-diastasis rectus abdominus (DRA), inter-rectus distance (IRA), centimeter (CM), body mass index (BMI)