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TMJ PainNCT06966557

Nerve Block Treatment for Chronic Jaw Pain

An observational study of TMJ Pain, run by Bnai Zion Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Study Summary: Nerve Block Treatment for Chronic Jaw Pain This study is being conducted at the TMJ (temporomandibular joint) clinic, which is part of the oral and maxillofacial surgery department. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
TMJ Pain
How many people
40 participants
Where
1 siteIsrael
Study dates
25 Apr 2025to Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with chronic temporomandibular joint (TMJ) pain who attend the TMJ clinic at Beni Zion hospital, part of the Department of Oral and Maxillofacial Surgery. Participants are individuals who have experienced TMJ-related pain for at least one year and have not responded adequately to at least two prior treatment modalities (e.g., physiotherapy, medications, splints, or alternative therapies). Eligible patients will be those for whom a peripheral nerve block has been selected as part of their clinical care.

Who may be able to join

  • Adults (non-pregnant) with sound judgment
  • Chronic TMJ pain lasting at least 12 months
  • Documented failure of at least two previous treatment modalities

Who cannot join

  • not meeting inclusion criteria
  • Missing at least two follow-up visits within the specified timeframe

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel1 site, 1 recruiting
  • Department of Oral and Maxillofacial Surgery

    Haifa, North, 3199500

    Waseem A Abboud, MD, +972526657050, waseem.abboud@gmail.com

    Areen Khoury, DMD, +972509529584, areenkhoury1@mail.tau.ac.il

    Recruiting

Other trials in Israel

About this study

Official title: Treatment of Chronic Temporomandibular Pain With Peripheral Nerve Block

Study Summary: Nerve Block Treatment for Chronic Jaw Pain This study is being conducted at the TMJ (temporomandibular joint) clinic, which is part of the oral and maxillofacial surgery department. The goal is to evaluate how effective peripheral nerve blocks are in reducing long-term jaw pain in patients with chronic temporomandibular disorders (TMD) who haven't responded to at least two other types of treatment (such as physical therapy, medication, or bite splints).

What Is the Treatment? Peripheral nerve blocks are injections that temporarily block nerve signals from the painful area. This can relieve pain and improve function. These blocks are already used routinely at the clinic.

Read more

Who Can Join? Adults who have had jaw joint pain for over a year.

Have tried at least two other treatments without success.

Are mentally competent and not pregnant.

What Will Participation Involve? You'll receive the nerve block treatment as part of your regular care.

You'll be asked to attend follow-up visits, typically one every 4 months (3 per year).

You'll be monitored for pain relief, mouth opening ability, and use of pain medications.

You can stop participating at any time without affecting your care.

How Will Data Be Handled? Your information will be stored securely and coded to protect your identity.

Only the research team will have access to your personal information.

How Many People Will Be in the Study? The goal is to recruit 40 patients.

Read the detailed description

Background:

Chronic temporomandibular disorders (TMD) are a common source of orofacial pain, affecting both younger and older populations. Symptoms often include sharp, persistent pain in the temporomandibular joint (TMJ) region, difficulty opening or closing the mouth, and functional limitations in the jaw and facial muscles. The condition may arise from various causes, including trauma, genetic predisposition, and muscular or joint stress.

Conventional treatments-such as medications, physiotherapy, bite splints, and complementary therapies-offer relief to many patients, but a subset remains resistant to these modalities. In recent years, peripheral nerve blocks have emerged as a promising intervention for managing chronic TMD-related pain, particularly in patients unresponsive to standard care.

Purpose of the Study:

This prospective observational study aims to systematically assess the effectiveness of peripheral nerve blocks as a treatment for chronic temporomandibular pain. The intervention is already part of routine clinical care in the TMJ clinic, and this study will evaluate patient outcomes in a structured manner.

Study Design and Methods:

Patients attending the TMJ clinic at our institution, who meet specific inclusion criteria, will be invited to participate in a follow-up study after receiving a peripheral nerve block as part of their clinical care. The treatment involves injecting anesthetic near specific nerves to block pain signals from the TMJ region.

Data will be collected prospectively from up to 40 adult participants. Baseline and follow-up data will include:

Pain levels (using the Visual Analog Scale - VAS)

Mouth opening range (in millimeters)

Changes in the use of pain medication

Whether the patient requests repeat treatments

Demographics and relevant medical background (age, sex, comorbidities, previous treatments, physical activity)

Follow-up visits will occur as per the clinic's standard practice, typically every four months (total of three visits per year), with the possibility for earlier visits if symptoms worsen. Patients must attend at least two follow-up visits within four months post-injection to remain in the study.

Inclusion Criteria:

Adults (non-pregnant) with sound judgment

Chronic TMJ pain lasting at least 12 months

Documented failure of at least two previous treatment modalities

Exclusion Criteria:

Failure to meet inclusion criteria

Missing at least two follow-up visits within the specified timeframe

Data Handling and Confidentiality:

All data will be anonymized and stored in a secure, password-protected Excel file within the department. Only approved researchers will have access. Patient identifiers will be replaced with study codes. No personal identifying information will be published or disclosed.

Ethical Considerations:

The study will only begin after approval by the institutional Helsinki (ethics) committee. All participants will provide written informed consent after receiving a thorough explanation of the study. Participation is voluntary and will not impact the quality or accessibility of their medical care. Patients may withdraw at any time without consequence.

Statistical Analysis:

The main outcomes (VAS scores, analgesic use, and mouth opening) will be compared before and after treatment using standard statistical methods. Subgroup analyses will explore correlations between outcomes and demographic/clinical variables such as age, sex, and previous treatment history.

Conditions
TMJ Pain
Keywords
TMJ Pain, Nerve block, Peripheral nerve block, Chronic temporomandibular pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS pain intensity

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable), before and after treatment.

    Measured: One year

Secondary outcomes (2)
  1. Mouth opening meausurement

    Maximal mouth opening (in millimeters) will be measured before and after treatment.

    Measured: One year

  2. Change in analgesic use

    Patient-reported use of pain medications before and after the nerve block treatment.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2025
  2. Study start25 Apr 2025
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966557
Sponsor's protocol ID
BnaiZion -TMJ2025
Status last verified
Apr 2025
First submitted
4 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of TMJ Pain, run by Bnai Zion Medical Center at 1 site in Israel.

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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Jun 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS pain intensity (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jun 2025.

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