Myofascial Pain Syndrome, Temporomandibular Joint Disorders, Facial Pain
Conditions
Keywords
Trigger point injection, orofacial pain
Brief summary
This randomized clinical trial will aim to compare the effectiveness of dry needling, lidocaine injection, and mepivacaine injection in the treatment of myofascial pain in the masticatory muscles. A total of 75 participants with bilateral active trigger points in the masseter and/or temporalis muscles will be enrolled and randomly assigned to three intervention groups. Each participant will receive weekly treatments for three weeks. Pain levels, depressive symptoms, and temporomandibular disorder severity will be assessed using the Visual Analog Scale, the Beck Depression Inventory, and the Fonseca Anamnestic Index. Outcome measures will be recorded at baseline and one week after the final treatment session. The primary objective of this study is to determine which intervention provides the greatest improvement in myofascial pain symptoms.
Detailed description
This study will be a randomized, controlled clinical trial designed to compare the effectiveness of dry needling, lidocaine, and mepivacaine injections in the treatment of myofascial pain in the masticatory muscles. Seventy-five participants with bilateral active myofascial trigger points in the masseter and/or temporalis muscles will be recruited. Participants will be randomly assigned to one of three intervention groups: dry needling, lidocaine (20 mg/mL), or mepivacaine (30 mg/mL). Injections will be administered once a week for three consecutive weeks to both sides of the face. Pain levels will be evaluated using the Visual Analog Scale, depressive symptoms with the Beck Depression Inventory and temporomandibular disorder severity with the Fonseca Anamnestic Index. Measurements will be performed at baseline (prior to first injection) and one week after the third and final injection. The study will be conducted at Istanbul Medipol University with ethics committee approval. Participants will be informed about the study procedures and informed consent will be obtained from all subjects. The primary objective of the study is to evaluate which intervention provides the most significant reduction in pain and associated symptoms of myofascial pain syndrome. Secondary outcomes will include improvements in depressive symptoms and temporomandibular disorder-related limitations.
Interventions
PROCEDUREDry Needling
Dry needling applied to bilateral active trigger points in the masseter and temporalis muscles once per week for three weeks.
PROCEDURELidocaine Hydrochloride
Lidocaine (20 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.
PROCEDUREMepivacaine Hydrochloride
Mepivacaine (30 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.
Sponsors
Sümer Münevveroğlu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
participants will be randomly assigned to one of three parallel arms: dry needling, lidocaine injection, or mepivacaine injection. All interventions will be applied once a week for three consecutive weeks. Outcome measures will be assessed at baseline and one week after the final injection.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 64 years * Presence of bilateral active myofascial trigger points in both the masseter and temporalis muscles * Pain provoked by approximately 1 kg of external digital pressure on trigger points * Willingness to participate and provide informed consent
Exclusion criteria
* Previous or ongoing treatment for temporomandibular disorders (e.g., occlusal splints, botulinum toxin injections) * Presence of systemic neuromuscular disease * Pregnancy or breastfeeding * Use of analgesics, muscle relaxants, or antidepressants within the past 2 weeks * Active infection, tumor, or trauma in the orofacial region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity based on the Visual Analog Scale | Baseline and one week after the third injection | Pain intensity will be assessed using a 10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst possible pain. The change in VAS scores from baseline to post-treatment will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms based on the Beck Depression Inventory | Baseline and one week after the third injection | Change in depressive symptoms based on the Beck Depression Inventory (BDI). The BDI is a 21-item self-reported questionnaire that measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating more severe depression. |
| Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index | Baseline and one week after the third injection | Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index. The Fonseca Anamnestic Index consists of 10 items assessing TMD-related symptoms. Total scores range from 0 to 100, with higher scores indicating more severe temporomandibular dysfunction. |
Countries
Turkey (Türkiye)
Outcome results
None listed