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

Rectus Diastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05229692
• Other study ID #: STUDY00000863
• Status: Withdrawn
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: NeuFit - Neurological Fitness and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectus Diastasis

Intervention

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

Locations

Country	Name	City	State
United States	Piazza Center for Plastic Surgery and Advanced Skin Care	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
NeuFit - Neurological Fitness and Education	University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	Pre-intervention
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	Pre-intervention
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	2 weeks
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	2 weeks
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	4 weeks
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	4 weeks
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	6 weeks
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	6 weeks
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	8 weeks
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	8 weeks
Primary	Core strength and endurance plank	Core strength and endurance will be measured by duration of ability to hold a plank.	12 weeks
Primary	Core strength and endurance bridge	Core strength and endurance will be measured by duration of ability to hold a glute bridge.	12 weeks
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	Pre-intervention
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	2 weeks
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	4 weeks
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	6 weeks
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	8 weeks
Primary	Lower abdominal strength	Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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