Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Not Applicable

Terminated

• Conditions: Diastasis Recti
• Interventions: Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

• Registration Number: NCT04060563
• Lead Sponsor: Diana Trang

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-19
• Study Start: 2020-01-01
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Results First Submitted: 2024-01-12
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Results First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frequency specific microcurrent therapy	INSPIRSTAR IS02 MICROCURRENT STIMULATOR	Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8),
Sham (fake) microcurrent therapy	INSPIRSTAR IS02 MICROCURRENT STIMULATOR	Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode )

Primary Outcome Measures

Name	Time	Method
Inter-rectus Distances (IRD)	visit 3/week 3	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.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States