Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Study Overview
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Brief Summary
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Determine if frequency specific microcurrent therapy improves pain management of DRA by 30% or greater.

Detailed Description
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Females aged 18 years or older who are postpartum from a singleton gestation status post vaginal and with diastasis recti will be recruited. The aim of this study is to determine if frequency specific microcurrent therapy improves pain management of DRA by 30% or greater Improving DRA after microcurrent therapy in post-partum females may allow a faster, more effective return to activity thereby improving the return-to-duty transition and establishing personal readiness by meeting military fitness standards.

Official Title
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Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Conditions
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Diastasis Recti

Intervention / Treatment
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* Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR


Participation Criteria
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Eligibility Criteria
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Active Duty and DoD beneficiary Postpartum Females (12 hours to 24 hours) with Diastasis Rectus Abdominus (DRA) pain 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) Exclusion Criteria: less than 18 years of age females greater than 24 hours post-partum Medical history to include pacemaker History of arrhythmia Transplant status Insulin pump Pain pump Active cancer Inability to measure IRD Delivery via caesarean section Operative vaginal delivery (vacuum or forceps) 3rd or 4th degree vaginal laceration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham (fake) microcurrent therapy<br>Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode ) | Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR<br>* Investigators will use the Inspirstar microcurrent stimulator TENS device. It is an FDA 510k approved portable hand-held device used for the symptomatic relief of chronic pain. It generates low current intensity pulses in the ranges of 20μA to 400μA. For this study, investigators will use a treatment range of 100-300μA. Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), times 2 treatments for a consistent total of 11 hours 32 minutes.<br>|
| Experimental: Frequency specific microcurrent therapy<br>Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), | Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR<br>* Investigators will use the Inspirstar microcurrent stimulator TENS device. It is an FDA 510k approved portable hand-held device used for the symptomatic relief of chronic pain. It generates low current intensity pulses in the ranges of 20μA to 400μA. For this study, investigators will use a treatment range of 100-300μA. Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), times 2 treatments for a consistent total of 11 hours 32 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rectus distances (IRD) | Investigator will apply ultrasound gel and measure Inter-rectus distances (IRD) -- via ultrasound or if unable via ultrasound, via palpation and measuring tape -- taken at 4 locations using the medial margins of both rectus abdominis muscles: A. 2.5 cm above the umbilical ring, B. upper margin of the umbilical ring, C. lower margin of the umbilical ring, and D. 2.5 cm below the umbilical ring. | screening | 
| Inter-rectus distances (IRD) | Investigator will apply ultrasound gel and measure Inter-rectus distances (IRD) -- via ultrasound or if unable via ultrasound, via palpation and measuring tape -- taken at 4 locations using the medial margins of both rectus abdominis muscles: A. 2.5 cm above the umbilical ring, B. upper margin of the umbilical ring, C. lower margin of the umbilical ring, and D. 2.5 cm below the umbilical ring. | visit 1/ week 0 | 
| Inter-rectus distances (IRD) | Investigator will apply ultrasound gel and measure Inter-rectus distances (IRD) -- via ultrasound or if unable via ultrasound, via palpation and measuring tape -- taken at 4 locations using the medial margins of both rectus abdominis muscles: A. 2.5 cm above the umbilical ring, B. upper margin of the umbilical ring, C. lower margin of the umbilical ring, and D. 2.5 cm below the umbilical ring. | visit 2/ week2 | 
| Inter-rectus distances (IRD) | Investigator will apply ultrasound gel and measure Inter-rectus distances (IRD) -- via ultrasound or if unable via ultrasound, via palpation and measuring tape -- taken at 4 locations using the medial margins of both rectus abdominis muscles: A. 2.5 cm above the umbilical ring, B. upper margin of the umbilical ring, C. lower margin of the umbilical ring, and D. 2.5 cm below the umbilical ring. | visit 3/ week 4-12 (will occurr only once in this specified time frame) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Image States Scale (BISS) | The Body Image States Scale (BISS) is a six-item measure of individuals' evaluation and affect about their physical appearance at a particular moment in time. The BISS is acceptably internally consistent. BISS is appropriately correlated with various trait measures of body image. It is sensitive to reactions in positive versus negative situational contexts. Sex differences reflect those expected from the literature. Construct validity has been confirmed by an experiment on differential reactivity to appearance-related information as a function of level of dysfunctional body-image investment. Responses to each item were based on 9-point, bipolar, Likert-type scales, semantically anchored at each point. The scale was presented in a negative-to-positive direction for half of the items and a positive-to-negative direction for the other half. https://pdfs.semanticscholar.org/179a/96283407d3ffdd73030c18ac26138da338b4.pdf | visit 3/ week 4-12 (will occurr only once in this specified time frame) | 
| Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7) | The PFIQ-7 is a shortened version of the PFIQ and is used to assess life impact in women with pelvic floor disorders. It includes all of the Incontinence Impact Questionnaire-7 as well as items related to other pelvic floor disorders. It is intended for women with disorders of the pelvic floor including urinary incontinence, pelvic organ prolapse, and fecal incontinence. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300). The PFIQ-7 demonstrates construct validity as it demonstrates a significant association with appropriate measures of symptom severity and pelvic floor diagnoses. | visit 3/ week 4-12 (will occurr only once in this specified time frame) | 
| Defense and Veterans Pain Rating Scale for lumbar pain and pelvic pain (DVPRS). | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. | visit 3/ week 4-12 (will occurr only once in this specified time frame) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diastasis recti, postpartum, family medicine, microcurrent