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

Saglik Bilimleri Universitesi

Status: Completed

Conditions: Myalgia; Bruxism; Quality of Life

Treatments: Drug: Myorel; Procedure: Manual therapy; Drug: Botulinum toxin; Procedure: Dry needling

Study type: Interventional

Funder types: Other

Identifiers

NCT06583551

20/120

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin

Group 2

Active Comparator group

Description:

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.

Treatment:

Procedure: Dry needling

Group 3

Active Comparator group

Description:

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.

Treatment:

Drug: Myorel

Group 4

Active Comparator group

Description:

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.

Treatment:

Procedure: Manual therapy