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

Comparison of the Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia: a Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06583551
Enrollment
80
Registered
2024-09-04
Start date
2021-01-03
Completion date
2021-09-01
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Myalgia, Quality of Life

Keywords

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

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.

Detailed 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).

Interventions

DRUGBotulinum 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.

PROCEDUREDry 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.

DRUGMyorel

Metacarbamol (380mg), paracetamol (300mg)

PROCEDUREManual 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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain in at rest and at chewing12 weeksAverage pain was measured by a scale, named Visual analogue scale.
MMO12 weeksMaximum painless mouth opening (in millimeters) was measured by a special ruler.
OHRQoL questionnaire12 weeksOral-health-related quality of life

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026