NCT04060563 - Frequency Specific Microcurrent for the Treatment of Diastasis Recti | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

13

Conditions

Diastasis Recti

Interventions

INSPIRSTAR IS02 MICROCURRENT STIMULATORDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

\*\*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

Locations (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, United States

Outcomes

Primary Outcomes

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. A and D were recorded.

Time frame: screening (pre and post initial treatment)

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. A and D were recorded.

Time frame: visit 2/week 2

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. A and D were recorded.

Time frame: visit 3/week 3