An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
ConditionTemporomandibular Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorTheranica
About this trial
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. Up to 70% of the general population experiences signs and/or symptoms of TMD, with headache presenting as one of the most common manifestations. Recent studies highlight the comorbid presence of headache and TMD, hypothesizing that a relationship likely exists between the two conditions. Headache severity has also been associated with the number of TMD symptoms such that the prevalence of headache in TMD patients. A key mechanism underlying both TMD and migraine is the deficiency in Conditioned Pain Modulation (CPM), a descending inhibitory pathway that regulates pain processing. CPM impairment has been implicated in chronic pain states, including both migraine and TMD, contributing to their frequent co-occurrence and shared pathophysiology.
Remote Electrical Neuromodulation (REN) is an emerging non-pharmacological intervention that exerts its analgesic effects by activating the CPM system, which is deficient in individuals with TMD and migraine. The Nerivio REN wearable device is FDA-cleared for acute and/or migraine prevention, in patients 8 years of age or older. Given the evidence linking CPM dysfunction to TMD pathogenesis, REN presents a promising therapeutic approach to addressing both the underlying pain dysregulation and symptom burden in affected patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Nerivio treatment
DeviceNerivio, a Remote electrical neuromodulation (REN) device. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Nerivio treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in daily maximum-pain level
The change in daily maximum-pain level (on the numeric rating scale, NRS, of 0-10) as measured by comparing the average daily maximum orofacial-pain score in the last 2 weeks of baseline phase (weeks 3-4) to the last 2 weeks of the intervention phase (weeks 9-10). Pain score will be taken from any of the orofacial locations specified in the daily diary (jaw, head, neck, ear, eye, face, teeth) that presented the maximum daily pain. Patients will log their maximum pain levels in a daily diary, through a study specific smartphone application.
Time frame
10 weeksSecondary outcomes
1
Change in Jaw pain level
Change in Jaw pain level (0-10 NRS) as measured by comparing the average daily maximum-pain score in the last 2 weeks of baseline phase (weeks 3-4) to the last 2 weeks of the intervention phase (weeks 9-10).
Time frame
10 weeks2
Functional changes in jaw mobility
Functional changes in jaw mobility will be measured by a health care provider in all participants at the end of the baseline phase (visit 2) and at week 10 (visit 3) to determine whether REN improves pain-free maximum mouth opening (MMO) scores (a clinically relevant improvement being defined as \>5mm). Jaw mobility range of motion, is assessed by measuring maximum mouth opening, and side-to-side (lateral) movement
Time frame
10 weeks3
Change in self-reported Jaw Functional Limitation Scale (JFLS)
Change in the self-reported Jaw Functional Limitation Scale (JFLS) from the end of the baseline phase (visit 2) to following the intervention phase at week 10 (visit 3) to compare post-treatment changes in limitations of jaw function.
Time frame
10 weeks4
Change in headache pain level
Change in headache pain level (0-10 NRS) as measured by comparing the average daily maximum-pain score in the last 2 weeks of baseline phase (weeks 3-4) to the last 2 weeks of the intervention phase (weeks 9-10).
Time frame
10 weeks Source ClinicalTrials.gov