Frequency Specific Microcurrent for the Treatment of Diastasis Recti

NCT04060563 | Terminated Results FDA Device

• 1 other identifier: FWH20190124H
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diastasis Recti

Keywords

diastasis recti; postpartum; family medicine; microcurrent

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  visit 3/week 3

Study Arms (2)

Sham (fake) microcurrent therapy

SHAM COMPARATOR

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

Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

Frequency specific microcurrent therapy

EXPERIMENTAL

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

Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

Interventions

INSPIRSTAR IS02 MICROCURRENT STIMULATOR DEVICE

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.

Frequency specific microcurrent therapy; Sham (fake) microcurrent therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• rd or 4th degree vaginal laceration

Sponsors & Collaborators

• Diana Trang: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (8)

• Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.

  PMID: 24268942 BACKGROUND

• Chiarello CM, McAuley JA, Hartigan EH. Immediate Effect of Active Abdominal Contraction on Inter-recti Distance. J Orthop Sports Phys Ther. 2016 Mar;46(3):177-83. doi: 10.2519/jospt.2016.6102. Epub 2016 Jan 26.

  PMID: 26813756 BACKGROUND

• Fernandes da Mota PG, Pascoal AG, Carita AI, Bo K. Prevalence and risk factors of diastasis recti abdominis from late pregnancy to 6 months postpartum, and relationship with lumbo-pelvic pain. Man Ther. 2015 Feb;20(1):200-5. doi: 10.1016/j.math.2014.09.002. Epub 2014 Sep 19.

  PMID: 25282439 BACKGROUND

• Keshwani N, Mathur S, McLean L. Validity of Inter-rectus Distance Measurement in Postpartum Women Using Extended Field-of-View Ultrasound Imaging Techniques. J Orthop Sports Phys Ther. 2015 Oct;45(10):808-13. doi: 10.2519/jospt.2015.6143. Epub 2015 Aug 24.

  PMID: 26304645 BACKGROUND

• Keshwani N, Mathur S, McLean L. Relationship Between Interrectus Distance and Symptom Severity in Women With Diastasis Recti Abdominis in the Early Postpartum Period. Phys Ther. 2018 Mar 1;98(3):182-190. doi: 10.1093/ptj/pzx117.

  PMID: 29228344 BACKGROUND

• Liaw LJ, Hsu MJ, Liao CF, Liu MF, Hsu AT. The relationships between inter-recti distance measured by ultrasound imaging and abdominal muscle function in postpartum women: a 6-month follow-up study. J Orthop Sports Phys Ther. 2011 Jun;41(6):435-43. doi: 10.2519/jospt.2011.3507. Epub 2011 Feb 2.

  PMID: 21289454 BACKGROUND

• Sancho MF, Pascoal AG, Mota P, Bo K. Abdominal exercises affect inter-rectus distance in postpartum women: a two-dimensional ultrasound study. Physiotherapy. 2015 Sep;101(3):286-91. doi: 10.1016/j.physio.2015.04.004. Epub 2015 May 6.

  PMID: 26094117 BACKGROUND

• Goossen, S., Demitry, P. (2018) Frequencies for Physical Therapy.

  BACKGROUND

Limitations and Caveats

This study was terminated due to slow enrollment.

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.crawford.ctr@health.mil

7026533583

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 19, 2019
• Study Start: January 1, 2020
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)