Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
NCT ID: NCT05229692
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-06-25
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Texas at Austin
OTHER
NeuFit - Neurological Fitness and Education
INDUSTRY
Responsible Party
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Principal Investigators
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Rocco Piazza, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas - Austin
Locations
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Piazza Center for Plastic Surgery and Advanced Skin Care
Austin, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00000863
Identifier Type: -
Identifier Source: org_study_id
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