Clinical trial NCT04060563: Frequency Specific Microcurrent for the Treatment of Diastasis Recti
Official title: Frequency Specific Microcurrent for the Treatment of Diastasis Recti
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diastasis Recti
Keywords: diastasis recti
postpartum
family medicine
microcurrent
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2019-08-19
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Inter-rectus Distances (IRD)
timeFrame: screening (pre and post initial treatment)
measure: Inter-rectus Distances (IRD)
timeFrame: visit 2/week 2
measure: Inter-rectus Distances (IRD)
timeFrame: visit 3/week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
References:
citation: 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.
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.
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.
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.
citation: 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.
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.
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.
citation: Goossen, S., Demitry, P. (2018) Frequencies for Physical Therapy.