Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in P… (NCT03917160) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in Post - Partum Women
United States60 participantsStarted 2019-03-27
Plain-language summary
The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Post-partum women aged 18-45 years with symptoms of diastasis recti and weakness of the linea alba
* Informed Consent Form signed by the subject.
* BMI interval: 18.5 ≤ BMI ≤ 32 (normal to overweight, but not obese).
* Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
* Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
* In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
Exclusion Criteria:
* \- Unable to commit to future appointments
* Planning on moving away from the local area within 6 months
* History of other energy-based therapy within one year
* Diffuse pain syndrome or chronic pain requiring daily narcotics
* Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator
* Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other.
* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies o…
What they're measuring
1
Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
Timeframe: 1 month
2
Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment