Diastasis Recti
Conditions
Keywords
diastasis recti, postpartum, family medicine, microcurrent
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.
Interventions
DEVICEINSPIRSTAR 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.
Sponsors
Diana Trang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rectus Distances (IRD) | 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. |
Countries
United States
Participant flow
Recruitment details
Study terminated early at 13/160 subjects enrolled due to slow enrollment. 1 subject screenfailed.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 8 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Sham (Fake) Microcurrent Therapy | Frequency Specific Microcurrent Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 6 Participants |
| Region of Enrollment United States | 4 participants | 8 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 8 |
| other Total, other adverse events | 0 / 4 | 0 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 |
Outcome results
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.
Time frame: screening (pre and post initial treatment)
Population: No subject data was analyzed by a biostatistician due to study termination for slow/lack of enrollment. Raw data are reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring (pre) | 4.74 centimeters |
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring (post) | 4.89 centimeters |
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring (pre) | 2.23 centimeters |
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring (post) | 2.14 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring (post) | 1.84 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring (pre) | 3.88 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring (pre) | 1.85 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring (post) | 3.3 centimeters |
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.
Time frame: visit 2/week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring | 3.42 centimeters |
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring | 1.46 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring | 2.46 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring | 1.68 centimeters |
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.
Time frame: visit 3/week 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring | 3.1 centimeters |
| Sham (Fake) Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring | 1.28 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm above umbilical ring | 2.16 centimeters |
| Frequency Specific Microcurrent Therapy | Inter-rectus Distances (IRD) | inter-rectus distance 2.5 cm below umbilical ring | 1.56 centimeters |