NCT04060563

Frequency Specific Microcurrent for the Treatment of Diastasis Recti

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Diana Trang · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diastasis Recti

Interventions

Type	Name	Description
DEVICE	INSPIRSTAR IS02 MICROCURRENT STIMULATOR	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-07-07
• Completion: 2021-07-07
• First posted: 2019-08-19
• Last updated: 2024-04-02
• Results posted: 2024-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study