Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-03

Study Completion Date

2021-09-01

Brief Summary

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Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.

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Detailed Description

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The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy (PT), and manual therapy (MT). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. Botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. The following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; Visual Analogue Scale (VAS) for pain, maximum painless mouth opening (mm), Oral Health Impact Profile14 (OHIP-14).

Conditions

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Myalgia Bruxism Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Botulinum toxin (BTX-A) injection (n=20) Group 2: Dry needling (DN) (n=20) Group 3: Pharmacological therapy (PT) (n=20) Group 4: Manual therapy (MT) (n=20)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants were informed only about the type of treatment they received. The results were measured and recorded by another researcher other than the operator.

Study Groups

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Group 1

A single session of Botox (Botulinum toxin A) injection was performed. 50 IU was administered bilaterally by intramuscular injection: 30 IU within the masseter muscles and 20 IU within the anterior temporalis muscles.

Group Type ACTIVE_COMPARATOR

Botulinum toxin

Intervention Type DRUG

Botulinum toxin, produced by Clostridium botulinum, is a neurotoxin. Presently, there are 7 serotypes (A, B, C1, D, E, F, G). Botulinum neurotoxin A (BoNT-A) is the most frequently used variant in clinical applications.

Group 2

Dry needling was performed using sterile plastic cylindrical guide needles (25 mm length, 0.25 mm diameter) The needles were inserted 5 mm deep into hypertonic and irritable nodules (trigger points, TrPs) within the masseter and temporalis muscles. Each needle was rotated twice clockwise and then removed after remaining in the TrPs for a total of 20 minutes. The treatment was administered in three sessions, each one week apart.

Group Type ACTIVE_COMPARATOR

Dry needling

Intervention Type PROCEDURE

Dry needling (DN) is a type of acupuncture therapy, that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points (MTrPs) and muscular, and connective tissues.

Group 3

Pharmacological treatment was administered by prescribing Miyorel, a combination of methocarbamol (380 mg) and paracetamol (300 mg). The prescribed dosage was two tablets, taken three times daily, for a period of three weeks.

Group Type ACTIVE_COMPARATOR

Myorel

Intervention Type DRUG

Metacarbamol (380mg), paracetamol (300mg)

Group 4

Manual therapy was administered, consisting of bilateral facial massage and stretching maneuvers targeting the masseter and temporalis muscles. This treatment was performed for 20 minutes daily over a period of three weeks.

Group Type ACTIVE_COMPARATOR

Manual therapy

Intervention Type PROCEDURE

Manual therapy (MT) entails the use of the hands to apply a force with a therapeutic intent, including techniques such as massage, joint mobilization/manipulation, myofascial release, nerve manipulation, strain/counterstrain, and acupressure.

Interventions

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Botulinum toxin

Botulinum toxin, produced by Clostridium botulinum, is a neurotoxin. Presently, there are 7 serotypes (A, B, C1, D, E, F, G). Botulinum neurotoxin A (BoNT-A) is the most frequently used variant in clinical applications.

Intervention Type DRUG

Dry needling

Dry needling (DN) is a type of acupuncture therapy, that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points (MTrPs) and muscular, and connective tissues.

Intervention Type PROCEDURE

Myorel

Metacarbamol (380mg), paracetamol (300mg)

Intervention Type DRUG

Manual therapy

Manual therapy (MT) entails the use of the hands to apply a force with a therapeutic intent, including techniques such as massage, joint mobilization/manipulation, myofascial release, nerve manipulation, strain/counterstrain, and acupressure.

Intervention Type PROCEDURE

Other Intervention Names

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Intramuscular injection of Botulinum toxin A. (BoNT-A)

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18 to 65 years with complete dentition,
* Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I or ASA II
* Patients experiencing moderate to severe pain in the masticatory muscles related to bruxism,
* Patients who had not previously been treated for bruxism
* Patients who were diagnosed with bruxism were excluded from the study.

Exclusion Criteria

* Presence of temporomandibular joint disorder
* Known allergy to botulinum toxin
* Pregnancy
* Presence of neuromuscular disease
* Chronic use of muscle relaxant medication within the last 3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes