Trial Outcomes & Findings for Frequency Specific Microcurrent for the Treatment of Diastasis Recti (NCT NCT04060563)
NCT ID: NCT04060563
Last Updated: 2024-04-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
screening (pre and post initial treatment)
Results posted on
2024-04-02
Participant Flow
Study terminated early at 13/160 subjects enrolled due to slow enrollment. 1 subject screenfailed.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Frequency Specific Microcurrent for the Treatment of Diastasis Recti
Baseline characteristics by cohort
| Measure |
Sham (Fake) Microcurrent Therapy
n=4 Participants
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.
|
Frequency Specific Microcurrent Therapy
n=8 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Sham (Fake) Microcurrent Therapy
n=4 Participants
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.
|
Frequency Specific Microcurrent Therapy
n=8 Participants
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.
|
|---|---|---|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm above umbilical ring (pre)
|
4.74 centimeters
Interval 3.89 to 6.83
|
3.88 centimeters
Interval 2.71 to 4.97
|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm above umbilical ring (post)
|
4.89 centimeters
Interval 3.64 to 7.62
|
3.3 centimeters
Interval 1.91 to 4.45
|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm below umbilical ring (pre)
|
2.23 centimeters
Interval 1.16 to 3.49
|
1.85 centimeters
Interval 1.25 to 2.62
|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm below umbilical ring (post)
|
2.14 centimeters
Interval 1.13 to 3.07
|
1.84 centimeters
Interval 1.06 to 2.05
|
PRIMARY outcome
Timeframe: visit 2/week 2Population: 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.
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.
Outcome measures
| Measure |
Sham (Fake) Microcurrent Therapy
n=4 Participants
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.
|
Frequency Specific Microcurrent Therapy
n=8 Participants
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.
|
|---|---|---|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm above umbilical ring
|
3.42 centimeters
Interval 3.17 to 3.66
|
2.46 centimeters
Interval 0.93 to 3.79
|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm below umbilical ring
|
1.46 centimeters
Interval 0.89 to 1.89
|
1.68 centimeters
Interval 0.71 to 4.25
|
PRIMARY outcome
Timeframe: visit 3/week 3Population: 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.
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.
Outcome measures
| Measure |
Sham (Fake) Microcurrent Therapy
n=4 Participants
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.
|
Frequency Specific Microcurrent Therapy
n=8 Participants
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.
|
|---|---|---|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm above umbilical ring
|
3.1 centimeters
Interval 2.23 to 3.46
|
2.16 centimeters
Interval 1.25 to 3.76
|
|
Inter-rectus Distances (IRD)
inter-rectus distance 2.5 cm below umbilical ring
|
1.28 centimeters
Interval 0.79 to 1.86
|
1.56 centimeters
Interval 0.33 to 3.76
|
Adverse Events
Sham (Fake) Microcurrent Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Frequency Specific Microcurrent Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place