Efficiency of Botulinum Toxin Type-a in the Management of the Myofascial Pain
NCT ID: NCT06840730
Last Updated: 2025-02-21
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-09-03
2025-02-13
Brief Summary
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\*\*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. It hypothesizes that BTX-A reduces pain by decreasing inflammatory cytokines and neuropeptides associated with pain.
\*\*Methodology:\*\*
* \*\*Study Design:\*\* Prospective observational clinical study.
* \*\*Participants:\*\* Patients diagnosed with MMD based on RDC/TMD criteria, who have not improved with conventional treatments.
* \*\*Exclusion Criteria:\*\* Conditions such as pregnancy, metabolic disorders, trauma, systemic diseases, and medication use that could interfere with results.
* \*\*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 one month after (T1) treatment.
* Clinical assessments include maximum mouth opening (MMO), pain levels (VAS), 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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botulinum toxin
TX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.
Botulinum Toxin A (Botox )
TX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.
Interventions
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Botulinum Toxin A (Botox )
TX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Salih Eren Meral
DDS phd
Locations
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Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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KA-23004
Identifier Type: -
Identifier Source: org_study_id
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