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Enrollment too slow.
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Determine if frequency specific microcurrent therapy improves pain management of DRA by 30% or greater.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ) |
|
| Frequency specific microcurrent therapy | Experimental | Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24268942 | Background | 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. | |
| 26813756 | 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. |
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We do not plan on sharing data
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Study terminated early at 13/160 subjects enrolled due to slow enrollment. 1 subject screenfailed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham (Fake) Microcurrent Therapy | Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode ) 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. |
| FG001 | Frequency Specific Microcurrent Therapy | Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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No analysis was conducted due to study termination for slow enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham (Fake) Microcurrent Therapy | Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode ) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No subject data was analyzed by a biostatistician due to study termination for slow/lack of enrollment. Raw data are reported. | Posted | Mean | Full Range | centimeters | screening (pre and post initial treatment) |
|
Duration of subject participation: 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham (Fake) Microcurrent Therapy | Sham (fake) microcurrent therapy (placing the microcurrent pads on the patient and turning the microcurrent box on placebo mode ) 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. |
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This study was terminated due to slow enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | MOMH | 7026533583 | amanda.j.crawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2021 | Jan 12, 2024 | Prot_SAP_002.pdf |
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|
| 25282439 | 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. |
| 26304645 | 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. |
| 29228344 | 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. |
| 21289454 | 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. |
| 26094117 | 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. |
| Background | Goossen, S., Demitry, P. (2018) Frequencies for Physical Therapy. |
| BG001 | Frequency Specific Microcurrent Therapy | Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Frequency Specific Microcurrent Therapy | Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), 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. |
|
|
| 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. | 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. | Posted | Mean | Full Range | centimeters | 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. | 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. | Posted | Mean | Full Range | centimeters | visit 3/week 3 |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Frequency Specific Microcurrent Therapy | Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| inter-rectus distance 2.5 cm below umbilical ring |
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| inter-rectus distance 2.5 cm below umbilical ring |
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