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.
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
- 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
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.
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)
Mouth opening meausurement
Maximal mouth opening (in millimeters) will be measured before and after treatment.
Measured: One year
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.
- First posted12 May 2025
- Study start25 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Temporomandibular Pain With Peripheral Nerve Block
- ClinicalTrials.gov ID
- NCT06966557
- Acronym / sponsor ID
- BnaiZion -TMJ2025
- Conditions
- TMJ Pain
- Keywords
- TMJ Pain, Nerve block, Peripheral nerve block, Chronic temporomandibular pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 May 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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Adults (non-pregnant) with sound judgment
- Chronic TMJ pain lasting at least 12 months
- Documented failure of at least two previous treatment modalities
Key exclusion criteria (2 listed)
- not meeting inclusion criteria
- Missing at least two follow-up visits within the specified timeframe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS pain intensity
Time frame: One year
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.
2 secondary outcomes
Mouth opening meausurement
Time frame: One year
Change in analgesic use
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
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.