Frequency Specific Microcurrent for the Treatment of Diastasis Recti

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

Study Overview

• Status: Terminated
• Conditions: Diastasis Recti
• Intervention / Treatment: Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Mike O'Callaghan Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

**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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham (fake) microcurrent therapy; Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode )	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.
Experimental: Frequency specific microcurrent therapy; Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8),	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Image States Scale (BISS)	The Body Image States Scale (BISS) is a six-item measure of individuals' evaluation and affect about their physical appearance at a particular moment in time. The BISS is acceptably internally consistent. BISS is appropriately correlated with various trait measures of body image. It is sensitive to reactions in positive versus negative situational contexts. Sex differences reflect those expected from the literature. Construct validity has been confirmed by an experiment on differential reactivity to appearance-related information as a function of level of dysfunctional body-image investment. Responses to each item were based on 9-point, bipolar, Likert-type scales, semantically anchored at each point. The scale was presented in a negative-to-positive direction for half of the items and a positive-to-negative direction for the other half. https://pdfs.semanticscholar.org/179a/96283407d3ffdd73030c18ac26138da338b4.pdf	visit 3/ week 4-12 (will occurr only once in this specified time frame)
Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7)	The PFIQ-7 is a shortened version of the PFIQ and is used to assess life impact in women with pelvic floor disorders. It includes all of the Incontinence Impact Questionnaire-7 as well as items related to other pelvic floor disorders. It is intended for women with disorders of the pelvic floor including urinary incontinence, pelvic organ prolapse, and fecal incontinence. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300). The PFIQ-7 demonstrates construct validity as it demonstrates a significant association with appropriate measures of symptom severity and pelvic floor diagnoses.	visit 3/ week 4-12 (will occurr only once in this specified time frame)
Defense and Veterans Pain Rating Scale for lumbar pain and pelvic pain (DVPRS).	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.	visit 3/ week 4-12 (will occurr only once in this specified time frame)

Collaborators and Investigators

• Sponsor: Diana Trang

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: microcurrent; postpartum; family medicine; diastasis recti
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: FWH20190124H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan on sharing data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No