Efficiency of Botulinum Toxin type-a in the Management of the Myofascial Pain

NCT06840730 | Completed

• 1 other identifier: KA-23004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

\*\*Study Title:\*\* Investigation of the Relationship Between Clinical Outcomes and Pain Mediators in the Treatment of Masticatory Muscle Disorders Associated with Myospasm Using Onabotulinum Toxin A \*\*Study Importance:\*\* Temporomandibular disorders (TMD) are a major cause of chronic orofacial pain, affecting 5-12% of the population. Masticatory muscle disorders (MMD) are a common subgroup of TMD, ranging from localized myalgia to fibromyalgia. Myospasm is characterized by sudden pain, malocclusion, and limited jaw movement, while myalgia includes localized, myofascial, and referred pain patterns. The etiology of MMD is complex, involving neuromuscular dysfunction, inflammation, and increased acetylcholine activity at the neuromuscular junction. Various mediators, including CGRP, substance P, and inflammatory cytokines, play a role in sensitization and pain perception. \*\*Objective:\*\* This study aims to evaluate the effectiveness of onabotulinum toxin A (BTX-A) in patients with MMD who have not responded to conventional non-invasive treatments. This exploratory study investigates whether BTX-A is associated with reductions in pain and inflammatory cytokines and neuropeptides. \*\*Methodology:\*\*

• \*\*Study Design:\*\* Prospective observational clinical study.
• \*\*Participants:\*\* Patients diagnosed with MMD based on DC/TMD criteria, who have not improved with conventional treatments.
• \*\*Exclusion Criteria:\*\*1) pregnancy or lactation; 2) use of oral contraceptives; 3) history of radiotherapy, active chemotherapy, or trauma in the maxillofacial region; 4)uncontrolled metabolic or systemic diseases; 5)active infections; allergic tendencies; significant tooth loss; 6) rheumatic diseases or other TMJ-defined disorders; 7) use of antidepressants or anti-inflammatory agents within the past week; 8) neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome); 9) planned surgical procedures in the near future, 10) individuals undergoing concomitant therapies.
• \*\*Intervention:\*\* BTX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.
• \*\*Data Collection:\*\*
• Before (T0) and 28 days after (T1) treatment.
• Clinical assessments include maximum mouth opening (MMO), pain levels (VAS), pain pressure threshold and oral health impact profile (OHIP-14).
• Blood and saliva samples will be analyzed for IL-1, IL-6, TNF-α, CGRP, and NGF using ELISA.
• \*\*Statistical Analysis:\*\* Dependent t-test or Wilcoxon signed-rank test will be used to compare pre- and post-treatment values. Correlations between biomarker levels and pain reduction will be analyzed using Spearman correlation. \*\*Expected Outcomes:\*\*
• Significant reduction in pain and improvement in MMO.
• Decreased levels of inflammatory and neuropeptide biomarkers.
• Evaluation of saliva as a non-invasive medium for biomarker analysis, potentially guiding future diagnostic and monitoring strategies. \*\*Significance:\*\* This study provides insights into the pathophysiology of MMD and the efficacy of BTX-A in pain management, potentially offering an alternative therapeutic approach for patients resistant to conventional treatments.

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Change in pain intensity measured using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity..

  Baseline and 28 days after injection

Secondary Outcomes (4)

• Change in Salivary and Serum Inflammatory Biomarker

  Baseline and 28 days after injection

• Change in Maximum Mouth Opening

  Baseline and 28 days after injection

• Change in Oral Health-Related Quality of Life

  Baseline and 28 days after injection

• Change in Pressure Pain Threshold

  Baseline and 28 days after injection

Study Arms (1)

botulinum toxin

EXPERIMENTAL

TX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.

Drug: Botulinum Toxin A (Botox )

Interventions

Botulinum Toxin A (Botox ) DRUG

TX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.

botulinum toxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS phd

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 21, 2025
• Study Start: June 3, 2024
• Primary Completion: January 12, 2025
• Study Completion: April 13, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

TU (1)