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

NCT06583551 | Completed

• 1 other identifier: 20/120
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myalgia; Bruxism; Quality of Life

Keywords

myalgia; Botulinum toxin; bruxism; Dry needling; manual therapy

Outcome Measures

Primary Outcomes (3)

• Pain in at rest and at chewing

  Average pain was measured by a scale, named Visual analogue scale.

  12 weeks

• MMO

  Maximum painless mouth opening (in millimeters) was measured by a special ruler.

  12 weeks

• OHRQoL questionnaire

  Oral-health-related quality of life

  12 weeks

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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.

Drug: Botulinum toxin

Group 2

ACTIVE COMPARATOR

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.

Procedure: Dry needling

Group 3

ACTIVE COMPARATOR

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.

Drug: Myorel

Group 4

ACTIVE COMPARATOR

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.

Procedure: Manual therapy

Interventions

Botulinum toxin 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.

Also known as: Intramuscular injection of Botulinum toxin A. (BoNT-A)

Group 1

Dry needling 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 2

Myorel DRUG

Metacarbamol (380mg), paracetamol (300mg)

Group 3

Manual therapy 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.

Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Sahin SS, Ciftci Sisman A, Atar E, Kilac H, Guzelce Sultanoglu E. Comparison of the effectiveness of botulinum toxin, dry needling, pharmacological treatment, and manual therapy for bruxism-induced myalgia: a prospective randomized study. J Oral Facial Pain Headache. 2024 Dec;38(4):101-110. doi: 10.22514/jofph.2024.043. Epub 2024 Dec 12.

  PMID: 39800961 DERIVED

MeSH Terms

Conditions

Myalgia; Bruxism

Interventions

Botulinum Toxins; incobotulinumtoxinA; Dry Needling; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• ALANUR CIFTCI SISMAN, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were informed only about the type of treatment they received. The results were measured and recorded by another researcher other than the operator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 4, 2024
• Study Start: January 3, 2021
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 4, 2024

Record last verified: 2021-01

Locations

TU (1)