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NCT Number: NCT07079449

Comparison of Lidocaine, Mepivacaine, and Dry Needling in Myofascial Pain Syndrome

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.

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Key information

Conditions

Myofascial Pain Syndrome Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, Faculty of Dentistry

Istanbul, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Procedure

Dry needling applied to bilateral active trigger points in the masseter and temporalis muscles once per week for three weeks.

Lidocaine Hydrochloride

Procedure

Lidocaine (20 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.

Mepivacaine Hydrochloride

Procedure

Mepivacaine (30 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.

Primary outcomes

  1. Change in pain intensity based on the Visual Analog Scale

    Time frame: 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 outcomes

  1. Change in depressive symptoms based on the Beck Depression Inventory

    Time frame: 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.

  2. Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sümer Münevveroğlu

Other

Registry information

Official study title

Trigger Point Injections for Myofascial Pain: A Comparative Study of Dry Needling, Lidocaine, and Mepivacaine

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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