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

NCT07079449 | Completed

• 1 other identifier: MEDIPOL-TMD-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndrome; Temporomandibular Joint Disorders; Facial Pain

Keywords

Trigger point injection; orofacial pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity based on the Visual Analog Scale

  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.

  Baseline and one week after the third injection

Secondary Outcomes (2)

• Change in depressive symptoms based on the Beck Depression Inventory

  Baseline and one week after the third injection

• Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index

  Baseline and one week after the third injection

Study Arms (3)

Lidocaine Group

EXPERIMENTAL

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.

Procedure: Lidocaine Hydrochloride

Mepivacaine Group

EXPERIMENTAL

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.

Procedure: Mepivacaine Hydrochloride

Dry Needling Group

EXPERIMENTAL

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.

Procedure: Dry Needling

Interventions

Dry Needling PROCEDURE

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

Dry Needling Group

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.

Lidocaine Group

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.

Mepivacaine Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sümer Münevveroğlu: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Facial Pain

Interventions

Dry Needling; Lidocaine; Mepivacaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: May 1, 2025
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)