Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Diana Trang

Status: Terminated

Conditions: Diastasis Recti

Treatments: Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04060563

FWH20190124H

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Sham (fake) microcurrent therapy

Sham Comparator group

Description:

Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode )

Treatment:

Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

Frequency specific microcurrent therapy

Experimental group

Description:

Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8),

Treatment:

Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR