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

NCT ID: NCT07079449

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-08-04

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.

Conditions

Myofascial Pain Syndrome; Temporomandibular Joint Disorders; Facial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lidocaine Group

Participants in this group will receive lidocaine (20 mg/mL) injected into each bilateral active trigger point in the masseter and temporalis muscles once per week for three weeks.

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type: PROCEDURE

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

Mepivacaine Group

Participants in this group will receive mepivacaine (30 mg/mL) injected into each bilateral active trigger point in the masseter and temporalis muscles once per week for three weeks.

Group Type: EXPERIMENTAL

Mepivacaine Hydrochloride

Intervention Type: PROCEDURE

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

Dry Needling Group

Participants in this group will receive dry needling applied to bilateral active trigger points in the masseter and temporalis muscles. Treatment will be administered once a week for three weeks.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: PROCEDURE

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

Interventions

Dry Needling

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

Intervention Type: PROCEDURE

Lidocaine Hydrochloride

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

Intervention Type: PROCEDURE

Mepivacaine Hydrochloride

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sümer Münevveroğlu

OTHER

Sponsor Role: lead

Responsible Party

Sümer Münevveroğlu

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istanbul Medipol University, Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MEDIPOL-TMD-01

Identifier Type: -

Identifier Source: org_study_id