Diastasis RectiNCT04060563

Frequency Specific Microcurrent for the Treatment of Diastasis Recti

A study testing INSPIRSTAR IS02 MICROCURRENT STIMULATOR in people with Diastasis Recti, run by Diana Trang at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Determine if frequency specific microcurrent therapy improves pain management of DRA by 30% or greater. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Diastasis Recti
What is being tested?: INSPIRSTAR IS02 MICROCURRENT STIMULATOR
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2020to 7 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 12Show fewer

Pain pump
Active cancer
Inability to measure IRD
Delivery via caesarean section
Operative vaginal delivery (vacuum or forceps)
3rd or 4th degree vaginal laceration

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

Read the 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
Being tested: INSPIRSTAR IS02 MICROCURRENT STIMULATOR
Keywords: diastasis recti, postpartum, family medicine, microcurrent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INSPIRSTAR IS02 MICROCURRENT STIMULATORDevice
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.

Study groups in NCT04060563
Study group	Role	What they receive
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 ) Receives: Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR
Frequency specific microcurrent therapy	Experimental	Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), Receives: Device: INSPIRSTAR IS02 MICROCURRENT STIMULATOR

What is being measured

The primary outcome is the main question the study is designed to answer.

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:
1. 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.
Measured: 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:
1. 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.
Measured: 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:
1. 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.
Measured: visit 3/week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20207 Jul 2021

First posted19 Aug 2019
Study start1 Jan 2020
Primary completion7 Jul 2021
Study completion7 Jul 2021

Why it stopped: Enrollment too slow.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Diastasis RectiStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04060563
Sponsor's protocol ID: FWH20190124H
Status last verified: Mar 2024
First submitted: 13 Aug 2019
Last updated: 2 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan on sharing data

Publications

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.
PubMed 24268942
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.
PubMed 26813756
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.
PubMed 25282439
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.
PubMed 26304645
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.
PubMed 29228344
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.
PubMed 21289454
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.
PubMed 26094117
Goossen, S., Demitry, P. (2018) Frequencies for Physical Therapy.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Recruiting
Effects of Corrective Versus Plank Exercises on Diastasis Recti
Diastasis Recti
Recruiting
Risk Factors and Exercise Effects on Abdominal Separation in Seniors
Diastasis Recti Abdominis (DRA), Aging
Active, not recruiting
Comparative Effects of Telerehabilitation Versus In-Person Core Stability Training in Postpartum Women
Postpartum, Diastasis Recti Abdominis (DRA)

All Diastasis Recti trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Frequency Specific Microcurrent for the Treatment of Diastasis Recti
ClinicalTrials.gov ID: NCT04060563
Acronym / sponsor ID: FWH20190124H
Conditions: Diastasis Recti
Keywords: diastasis recti, postpartum, family medicine, microcurrent
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment too slow.
Enrolment: 13 participants (actual)
Lead sponsor: Diana TrangUS federal agency
Study start: 1 Jan 2020 (actual)
Primary completion: 7 Jul 2021 (actual)
Study completion: 7 Jul 2021 (actual)
First posted: 19 Aug 2019 (actual)
Results: Posted 2 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Sham (fake) microcurrent therapy	Sham comparator	Device: INSPIRSTAR IS02 MICROCURRENT STIMULATORSham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode )
Frequency specific microcurrent therapy	Experimental	Device: INSPIRSTAR IS02 MICROCURRENT STIMULATORFrequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8),

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (12 listed)

less than 18 years of age
females greater than 24 hours post-partum
Medical history to include pacemaker
History of arrhythmia
Transplant status

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INSPIRSTAR IS02 MICROCURRENT STIMULATORInvestigators 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.	Device	Frequency specific microcurrent therapy, Sham (fake) microcurrent therapy

Primary outcome

Inter-rectus Distances (IRD)
Time frame: screening (pre and post initial treatment)
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.
Inter-rectus Distances (IRD)
Time frame: visit 2/week 2
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.
Inter-rectus Distances (IRD)
Time frame: visit 3/week 3
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.

Results and safety

Results posted to the registry on 2 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham (Fake) Microcurrent Therapy	4	3
Frequency Specific Microcurrent Therapy	8	6

Primary outcome: Inter-rectus Distances (IRD)

Time frame: screening (pre and post initial treatment). Mean (Full Range). Unit: centimeters

Measure	Sham (Fake) Microcurrent Therapy n = 4	Frequency Specific Microcurrent Therapy n = 8
inter-rectus distance 2.5 cm above umbilical ring (pre)	4.74 (3.89 to 6.83)	3.88 (2.71 to 4.97)
inter-rectus distance 2.5 cm above umbilical ring (post)	4.89 (3.64 to 7.62)	3.3 (1.91 to 4.45)
inter-rectus distance 2.5 cm below umbilical ring (pre)	2.23 (1.16 to 3.49)	1.85 (1.25 to 2.62)
inter-rectus distance 2.5 cm below umbilical ring (post)	2.14 (1.13 to 3.07)	1.84 (1.06 to 2.05)

Population analysed: No subject data was analyzed by a biostatistician due to study termination for slow/lack of enrollment. Raw data are reported.

Primary outcome: Inter-rectus Distances (IRD)

Time frame: visit 2/week 2. Mean (Full Range). Unit: centimeters

Measure	Sham (Fake) Microcurrent Therapy n = 4	Frequency Specific Microcurrent Therapy n = 8
inter-rectus distance 2.5 cm above umbilical ring	3.42 (3.17 to 3.66)	2.46 (.93 to 3.79)
inter-rectus distance 2.5 cm below umbilical ring	1.46 (0.89 to 1.89)	1.68 (0.71 to 4.25)

Population analysed: No subject data was analyzed by a biostatistician due to study termination for slow/lack of enrollment. Raw data are reported. 1 sham subject was lost to followup.

Primary outcome: Inter-rectus Distances (IRD)

Time frame: visit 3/week 3. Mean (Full Range). Unit: centimeters

Measure	Sham (Fake) Microcurrent Therapy n = 4	Frequency Specific Microcurrent Therapy n = 8
inter-rectus distance 2.5 cm above umbilical ring	3.1 (2.23 to 3.46)	2.16 (1.25 to 3.76)
inter-rectus distance 2.5 cm below umbilical ring	1.28 (0.79 to 1.86)	1.56 (0.33 to 3.76)

Population analysed: No subject data was analyzed by a biostatistician due to study termination for slow/lack of enrollment. Raw data are reported. 1 sham subject lost to followup. 2 intervention subjects lost to followup.

Adverse events

Time frame: Duration of subject participation: 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham (Fake) Microcurrent Therapy	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Frequency Specific Microcurrent Therapy	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): This study was terminated due to slow enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24268942Benjamin 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.
Background: PubMed 26813756Chiarello 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.
Background: PubMed 25282439Fernandes 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.
Background: PubMed 26304645Keshwani 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.
Background: PubMed 29228344Keshwani 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.
Background: PubMed 21289454Liaw 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.
Background: PubMed 26094117Sancho 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.
BackgroundGoossen, S., Demitry, P. (2018) Frequencies for Physical Therapy.
Individual participant dataSharing planned: No. We do not plan on sharing data

Related trials for Diastasis Recti

Recruiting
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing INSPIRSTAR IS02 MICROCURRENT STIMULATOR in people with Diastasis Recti, run by Diana Trang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-rectus Distances (IRD) (time frame: screening (pre and post initial treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060563, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.