Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty

NCT05310019 | Completed DMC

• 1 other identifier: 30725720.7.0000.5054.
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Goals. To evaluate the effect of electroacupuncture on paresthesia and myofunctional changes in patients undergoing bimaxillary orthognathic surgery and mentoplasty. Methodology: this is a controlled, randomized, blinded clinical trial. The sample will consist of 62 individuals in each group (general sample = 124 participants). Therefore, 124 young adults, aged between 18 and 50 years, both sexes, with at least 24 teeth, with Class II or III skeletal malocclusion, diagnosed by cephalometric radiographs, who underwent orthognathic surgery in the period from 1 to 30 days before the start of physical therapy, be available to perform the proposed postoperative treatment for six weeks. Participants will be equally and randomly distributed into two experimental groups: GF (Physiotherapy Group), GFE (Physiotherapy plus Electroacupuncture Group). The variables to be studied will be: socioepidemiological data; sensitivity assessment by the Semmes-Weinstein monofilament test; Edema assessment by the MD Anderson Cancer Center Head and Neck Lymphedema protocol, validated in Portuguese; assessment of mandibular movements using a Western-DC digital caliper; Assessment of masticatory function using the Chewing Quality Assessment Questionnaire. Data will be analyzed descriptively and organized into tables. Subsequently, the normality of continuous variables will be tested by the Kolmogorov-Smirnov test. As the variables are normally distributed, we will use parametric tests such as the paired t test, independent t test, ANOVA and Pearson's correlation. Nonparametric tests such as Wilcoxon paired signed rank test, Mann-Whitney U test, Kruskal Wallis test, Spearman correlation test will be used in case of non-normality of continuous variables. The significance level will be adjusted to 5% in all analyses.

Conditions

Paresthesia; Edema

Outcome Measures

Primary Outcomes (1)

• sensitivity assessment

  Using the Semmes-Weinstein monofilament test

  the sensitivity assessment at 6 months

Secondary Outcomes (3)

• measure range of motion

  The range of motion at at 6 months

• measure edema

  the edema assessment at 6 months

• measure functionality

  measure Functionality at 6 months

Study Arms (2)

Physiotherapy plus Electroacupuncture Group

EXPERIMENTAL

The physiotherapy treatment (50min): warm compress with facial thermal blanket, respiratory muscle mobility training and cervical muscle relaxation, facial lymphatic drainage, start of myolymphokinetic exercises for the orbicularis, zygomatic major and minor muscles, upper lip lifter and nose wing, buccinator and platysma, release of intraoral adhesions, vacuum therapy at 60 mmHg, active exercises free of mandibular movements, maintenance of mandibular opening with wooden tongue depressors. The electroacupuncture treatment lasting another 30 min. Electroacupuncture treatment lasting another 30min. The repetition time of 1 sec; (F1-10 Hz, F2= 45 Hz; 10 mA). Facial acupuncture needles are disposable with 0.20 mm gauge and 10 mm length. Each needle will be inserted at the indicated points, totaling 10 needles and electrodes will be connected to each one. Electrical stimulation will be performed on the face points: E4, Jiachengjiang (extra point), E5, E6, bilaterally and point CV-24.

Other: Physiotherapy and Electroacupuncture

Physiotherapy Group

ACTIVE COMPARATOR

The physiotherapy protocol will be the same as the active group. Protocol: warm compress with facial thermal blanket (5 min), respiratory muscle mobility training and cervical muscle relaxation (5 min) facial lymphatic drainage (10 min), start of myolyphokinetic exercises for the orbicularis oris, zygomatic major and minor, levator labii superioris and nasal ala, buccinator and platysma (5 min), release of intraoral adhesions (5 min) vacuum therapy at 60 mmHg (5 min), active exercises free of mandibular movements of right and left laterality, protrusion and mandibular opening (5 min), maintenance of mandibular opening with wooden tongue depressors (10 min).

Other: Physiotherapy

Interventions

Physiotherapy and Electroacupuncture OTHER

TThe physiotherapy treatment (50min): warm compress with facial thermal blanket, respiratory muscle mobility training and cervical muscle relaxation, facial lymphatic drainage, start of myolymphokinetic exercises for the orbicularis, zygomatic major and minor muscles, upper lip lifter and nose wing, buccinator and platysma, release of intraoral adhesions, vacuum therapy at 60 mmHg, active exercises free of mandibular movements, maintenance of mandibular opening with wooden tongue depressors. The electroacupuncture treatment lasting another 30 min. Electroacupuncture treatment lasting another 30min. The repetition time of 1 sec; (F1-10 Hz, F2= 45 Hz; 10 mA). Facial acupuncture needles are disposable with 0.20 mm gauge and 10 mm length. Each needle will be inserted at the indicated points, totaling 10 needles and electrodes will be connected to each one. Electrical stimulation will be performed on the face points: E4, Jiachengjiang (extra point), E5, E6, bilaterally and point CV-24.

Physiotherapy plus Electroacupuncture Group

Physiotherapy OTHER

The physiotherapy treatment protocol will be divided into 6 meetings: warm compress with facial thermal blanket (5min), respiratory muscle mobility training and cervical muscle relaxation (5min) facial lymphatic drainage (10min), start of myolymphokinetic exercises for the orbicularis oris, zygomatic major and minor muscles, upper lip lifter and nose wing, buccinator and platysma (5 min), release of intraoral adhesions (5min) vacuum therapy at 60 mmHg (5min), active exercises free of mandibular movements (5 min), maintenance of mandibular opening with wooden tongue depressors (10min).

Physiotherapy Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults undergoing bimaxillary orthognathic surgery and mentoplasty;
• Aged between 18 and 50 years;
• Both of genders,
• Having at least 24 teeth, with Class II or III skeletal malocclusion;
• Diagnosed by cephalometric radiographs, who have performed the surgery in the period from 1 to 45 days before the beginning of physiotherapy;
• Be available to perform the proposed postoperative treatment at the Clinic School of Physiotherapy of the Estácio do Ceará University Center for six weeks;
• Agree to participate in the research;
• Sign the term of free and clear clarification.

You may not qualify if:

• Individuals with cleft lip or palate, previous orthopedic and/or rheumatologic diseases that may have repercussions on the face such as facial fractures, facial palsy, systemic lupus erythematosus, neurological alteration due to injury or compression of the facial or trigeminal nerve;
• Patients with chronic lymphedema, individuals treated or undergoing cancer treatment, syndromic, with local vascular changes or who have undergone previous surgeries on the face such as bichectomy, TMJ surgery, with the exception of tooth extraction without associated nervous impairment, who performed other surgical procedures combined with orthognathic;
• Patients who use botulinum toxin for the treatment of temporomandibular dysfunction and esthetics;
• Patients who presented postoperative complications such as infectious processes.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Universidade Federal do Ceará: collaborator

Study Sites (1)

Clinic School of the University Center Estácio do Ceará

Fortaleza, Ceará, 60125-160, Brazil

Location

MeSH Terms

Conditions

Paresthesia; Edema

Interventions

Physical Therapy Modalities; Electroacupuncture

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Combined Modality Therapy; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Itana L Spinato

  Universidade Federal do Ceará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 4, 2022
• Study Start: September 1, 2020
• Primary Completion: December 10, 2024
• Study Completion: February 25, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

BR (1)