About this trial
This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC/TMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.
Eligibility criteria
Qualifiers
Having a diagnosis of myofascial pain syndrome
No missing teeth
No history of previous temporomandibular disorder treatment
Absence of an arthrogenic temporomandibular disorder
Disqualifiers
Pregnancy or lactation; osteoporosis and bisphosphonate use
Previous botulinum toxin injection to the masseter region
Bleeding disorders or use of anticoagulant medications
Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
Trial design
Treatments tested in this trial
- Botulinum toxin injection
- Occlusal splint
- Botulinum toxin + Occlusal splint combined