BridgeMD
New treatment option for Temporomandibular Disorder
Official title An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
ClinicalTrials.gov ID: NCT07639944
What this study is testing
- What it's testing
- Temporomandibular disorders (TMD) encompass a group of conditions involving the masticatory muscles, temporomandibular joint (TMJ), and associated structures. TMD is the most common cause of non-odontogenic orofacial pain and is the second most commonly occurring musculoskeletal condition.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Is of 12 years of age and older (inclusive; of any gender, race, or ethnicity)
- Meets diagnostic criteria for chronic TMD (Myalgia and/or Arthralgia) based on the Diagnostic Criteria for TMD (DC/TMD)
- Has experienced TMD pain for at least 6 months
- Has experienced TMD pain at level ≥4 on a 0-10 scale for at least 10 days of the last 30 days
- Commits to not making any changes to TMD treatment regime (medication and/or non-medication), including not adding or removing treatment, and if on...
You likely can't join if
- Has any of the following medical conditions: 1.1 Uncontrolled seizures/epilepsy 1.2 Benign and malignant TMJ and masticatory muscle tumors 1.3...
- Has experienced facial trauma or orofacial surgery within 6 weeks prior to the Screening and Baseline Visit
- Is undergoing current active orthodontic treatment
- Currently being treated with chemotherapy or radiation therapy
- Meets the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic or non-chronic migraine
- Currently taking an opioid medication, whether episodically or daily, within 30 days prior to the Screening and Baseline Visit
See the full eligibility criteria
- Is of 12 years of age and older (inclusive; of any gender, race, or ethnicity)
- Meets diagnostic criteria for chronic TMD (Myalgia and/or Arthralgia) based on the Diagnostic Criteria for TMD (DC/TMD)
- Has experienced TMD pain for at least 6 months
- Has experienced TMD pain at level ≥4 on a 0-10 scale for at least 10 days of the last 30 days
- Commits to not making any changes to TMD treatment regime (medication and/or non-medication), including not adding or removing treatment, and if on any existing treatment then maintaining the same treatment type...
- Naïve to REN treatment
- Willing and able to understand and comply with all study procedures and be available for the duration of the study
- Has their own smartphone or tablet device that is connected to the internet
- Provides a signed and dated informed consent form
- Has any of the following medical conditions: 1.1 Uncontrolled seizures/epilepsy 1.2 Benign and malignant TMJ and masticatory muscle tumors 1.3 Presence of implanted electrical device
- Has experienced facial trauma or orofacial surgery within 6 weeks prior to the Screening and Baseline Visit
- Is undergoing current active orthodontic treatment
- Currently being treated with chemotherapy or radiation therapy
- Meets the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic or non-chronic migraine
- Currently taking an opioid medication, whether episodically or daily, within 30 days prior to the Screening and Baseline Visit
- Has been treated with another investigational drug or treatment within 30 days prior to the Enrollment Visit
- Taking more than one prescription drug for the treatment of pain (including all types of drugs and modalities, e.g. pill, spray, injection) Note that this criterion does not refer to drug-free based treatments...
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
The study team makes the final eligibility decision.
Where it's taking place
- Ridgeland, Mississippi, United States
- Commack, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ridgeland, Mississippi, United States; Commack, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.