Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.

The purpose of this study is to determine the impact of rehabilitative training of the abdominal wall with direct current neuromuscular electrical stimulation (the NEUBIE device) on recovery time from abdominoplasty (tummy tuck).

Study Overview

• Status: Withdrawn
• Conditions: Rectus Diastasis
• Intervention / Treatment: Device: NEUBIE

Detailed Description

Participants will undergo abdominoplasty surgery and begin rehabilitation training within the first week post-operation. Standardized measurements of recovery progress will be taken starting prior to operation, and at 2, 4, 6, 8 and 12 weeks post-operation. Participants will undergo either the traditional standard of care of rest, with minimal activity for at least 6 weeks (control group) or a 5 week training course with the NEUBIE (experimental group), starting with passive electrical stimulation in the first week post-operation, and moving towards more advanced abdominal movements accompanied with stimulation in the subsequent four weeks.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78749
      • Piazza Center for Plastic Surgery and Advanced Skin Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Rectus Diastasis
2. Previous pregnancy
3. Excess localized adiposity in the lower abdomen
4. Excess atrophic skin of the abdomen
5. Physician clearance to participate
6. Scheduled for full abdominoplasty (no mini-abdominoplasty included)

Exclusion Criteria:

1. Currently pregnant
2. Cardiac Pacemaker
3. Active or recent cancer in the abdominal area
4. Active or recent blood clots in the abdominal area
5. History of epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEUBIE; Experimental group will receive rehabilitation training with the NEUBIE for 6 weeks post-operative. Training will occur at Neufit 2x a week from week 1-5, and will be administered by NeuFit clinic staff. Exercises and ability to complete exercises will be recorded by NeuFit staff in standardized clinic evaluation forms. Participants will undergo will undergo both active muscle tests and body analysis tests. Measurements will be taken at The Piazza Center by clinic staff prior to surgery at 2,4,6,8, and 12 weeks post-operative. Measurements will be used to demonstrate milestones of functional recovery, comparable between subjects by weeks achieved.	Device: NEUBIE; Participants will be asked to undergo electrical stimulation with the NEUBIE at their "treatment threshold". Treatment threshold will be described as "uncomfortable," but not "painful" (a 7 out of 10 on a perceived intensity scale). Session length: ≤ 30 minutes Treatment frequency: 2x per week for 5 weeks Week 1 post-op (treatments 1-2) Activity: Passive Neubie on Abdominals & Obliques Weeks 2-3 (treatments 3-6); Passive Neubie; Isometric movements with Neubie on abdominals and obliques; Active mobilizations with Neubie on abdominals and obliques Weeks 4-5 (treatments 7-10); Active mobilizations with Neubie on abdominals and obliques; Core Strength Exercise circuit with Neubie on abdominals and obliques; Other Names: NeuFit
No Intervention: Control; Control group will receive current post-operative standard of care for abdominoplasty, which includes using an abdominal binder, rest and minimal activity for 6 weeks. Participants will undergo both active muscle tests and body analysis tests. Measurements will be taken at The Piazza Center by clinic staff prior to surgery at 2,4,6,8, and 12 weeks post-operative. Measurements will be used to demonstrate milestones of functional recovery, comparable between subjects by weeks achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	Pre-intervention
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure body fat.	Pre-intervention
Bio-impedance analysis trunk mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	Pre-intervention
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	2 weeks
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.	2 weeks
Bio-impedance analysis trunk mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	2 weeks
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	4 weeks
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.	4 weeks
Bio-impedance analysis trunk mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	4 weeks
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	6 weeks
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.	6 weeks
Bio-impedance analysis trunk mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	6 weeks
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	8 weeks
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.	8 weeks
Bio-impedance analysis trunk mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	8 weeks
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.	12 weeks
Bio-impedance analysis trunk fat	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.	12 weeks
Bio-impedance analysis muscle mass	Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.	12 weeks
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	Pre-intervention
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	2 weeks
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	4 weeks
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	6 weeks
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	8 weeks
Range of Motion	Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.	12 weeks
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	Pre-intervention
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	Pre-intervention
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	2 weeks
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	2 weeks
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	4 weeks
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	4 weeks
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	6 weeks
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	6 weeks
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	8 weeks
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	8 weeks
Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	12 weeks
Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	12 weeks
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	Pre-intervention
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	2 weeks
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	4 weeks
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	6 weeks
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	8 weeks
Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	12 weeks
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	Pre-intervention
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	2 weeks
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	4 weeks
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	6 weeks
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	8 weeks
Sit up Test	Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.	12 weeks

Collaborators and Investigators

• Sponsor: NeuFit - Neurological Fitness and Education
• Collaborators: University of Texas at Austin
• Investigators: Principal Investigator: Rocco Piazza, MD, University of Texas - Austin

Publications and helpful links

General Publications

• da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
• Yue C, Zhang X, Zhu Y, Jia Y, Wang H, Liu Y. Systematic Review of Three Electrical Stimulation Techniques for Rehabilitation After Total Knee Arthroplasty. J Arthroplasty. 2018 Jul;33(7):2330-2337. doi: 10.1016/j.arth.2018.01.070. Epub 2018 Feb 6.
• Demircioglu DT, Paker N, Erbil E, Bugdayci D, Emre TY. The effect of neuromuscular electrical stimulation on functional status and quality of life after knee arthroplasty: a randomized controlled study. J Phys Ther Sci. 2015 Aug;27(8):2501-6. doi: 10.1589/jpts.27.2501. Epub 2015 Aug 21.
• Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081.
• Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
• Klika AK, Yakubek G, Piuzzi N, Calabrese G, Barsoum WK, Higuera CA. Neuromuscular Electrical Stimulation Use after Total Knee Arthroplasty Improves Early Return to Function: A Randomized Trial. J Knee Surg. 2022 Jan;35(1):104-111. doi: 10.1055/s-0040-1713420. Epub 2020 Jul 1.
• Delanois R, Sodhi N, Acuna A, Doll K, Mont MA, Bhave A. Use of home neuromuscular electrical stimulation in the first 6 weeks improves function and reduces pain after primary total knee arthroplasty: a matched comparison. Ann Transl Med. 2019 Oct;7(Suppl 7):S254. doi: 10.21037/atm.2019.09.150.
• Bistolfi A, Zanovello J, Ferracini R, Allisiardi F, Lioce E, Magistroni E, Berchialla P, Da Rold I, Massazza G. Evaluation of the Effectiveness of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty: A Meta-Analysis. Am J Phys Med Rehabil. 2018 Feb;97(2):123-130. doi: 10.1097/PHM.0000000000000847.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: neuromuscular electrical stimulation; abdominoplasty; NEUBIE; rectus diastatis
• Other Study ID Numbers: STUDY00000863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes