Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Diastasis Recti Clinical Trial

Official title:

Frequency Specific Microcurrent for the Treatment of Diastasis Recti

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04060563
• Other study ID #: FWH20190124H
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 7, 2021

Study information

• Verified date: March 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

**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

Related Conditions & MeSH terms

• Diastasis Recti
• Diastasis, Muscle

Intervention

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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Diana Trang

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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