Myofascial Pain SyndromeNCT07079449
Comparison of Lidocaine, Mepivacaine, and Dry Needling in Myofascial Pain Syndrome
A study testing Dry Needling, Lidocaine Hydrochloride and Mepivacaine Hydrochloride in people with Myofascial Pain Syndrome and Temporomandibular Joint Disorders, run by Sümer Münevveroğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Myofascial Pain Syndrome, Temporomandibular Joint Disorders, Facial Pain
- What is being tested?
- Dry Needling, Lidocaine Hydrochloride and Mepivacaine Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry
Istanbul, 34083
About this study
Official title: Trigger Point Injections for Myofascial Pain: A Comparative Study of Dry Needling, Lidocaine, and Mepivacaine
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.
Read the 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.
- Being tested
- Dry Needling, Lidocaine Hydrochloride, Mepivacaine Hydrochloride
- Keywords
- Trigger point injection, orofacial pain
- Medical subject headings
- Myofascial Pain Syndromes, Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Dry needling applied to bilateral active trigger points in the masseter and temporalis muscles once per week for three weeks.
Lidocaine HydrochlorideProcedure or surgery
Lidocaine (20 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.
Mepivacaine HydrochlorideProcedure or surgery
Mepivacaine (30 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one week after the third injection
Secondary outcomes (2)
Change in depressive symptoms based on the Beck Depression Inventory
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.
Measured: Baseline and one week after the third injection
Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index
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.
Measured: Baseline and one week after the third injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 May 2025
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümer Münevveroğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümer Münevveroğlu, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079449
- Sponsor's protocol ID
- MEDIPOL-TMD-01
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munevveroglu S, Basegmez D, Karaca HB. Dry needling, lidocaine, and mepivacaine for myofascial pain and associated temporomandibular disorder and depressive symptoms: a randomized clinical trial. BMC Oral Health. 2026 Jun 22. doi: 10.1186/s12903-026-08986-0. Online ahead of print.
PubMed 42324523
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Point Injections for Myofascial Pain: A Comparative Study of Dry Needling, Lidocaine, and Mepivacaine
- ClinicalTrials.gov ID
- NCT07079449
- Acronym / sponsor ID
- MEDIPOL-TMD-01
- Keywords
- Trigger point injection, orofacial pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sümer MünevveroğluUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Procedure: Lidocaine HydrochlorideParticipants 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. |
| Mepivacaine Group | Experimental | Procedure: Mepivacaine HydrochlorideParticipants 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. |
| Dry Needling Group | Experimental | Procedure: Dry NeedlingParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingDry needling applied to bilateral active trigger points in the masseter and temporalis muscles once per week for three weeks. | Procedure or surgery | Dry Needling Group |
| Lidocaine HydrochlorideLidocaine (20 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks. | Procedure or surgery | Lidocaine Group |
| Mepivacaine HydrochlorideMepivacaine (30 mg/mL) injected into each active trigger point in the masseter and temporalis muscles once per week for three weeks. | Procedure or surgery | Mepivacaine Group |
Primary outcome
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.
2 secondary outcomes
Change in depressive symptoms based on the Beck Depression Inventory
Time frame: Baseline and one week after the third injection
Change in temporomandibular disorder severity based on the Fonseca Anamnestic Index
Time frame: Baseline and one week after the third injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 42324523Munevveroglu S, Basegmez D, Karaca HB. Dry needling, lidocaine, and mepivacaine for myofascial pain and associated temporomandibular disorder and depressive symptoms: a randomized clinical trial. BMC Oral Health. 2026 Jun 22. doi: 10.1186/s12903-026-08986-0. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, Lidocaine Hydrochloride and Mepivacaine Hydrochloride in people with Myofascial Pain Syndrome and Temporomandibular Joint Disorders, run by Sümer Münevveroğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity based on the Visual Analog Scale (time frame: Baseline and one week after the third injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.