Trigeminal Neuralgia

Researchers are evaluating the Erchonia4 EVRL device to determine its effectiveness in providing temporary relief for chronic jaw pain caused by temporomandibular joint (TMJ) disorders. This clinical study focuses on nociceptive musculoskeletal pain arising from TMJ and aims to measure changes in pain levels and jaw function. The study compares the Erchonia4 EVRL, a handheld device with red and violet laser diodes, to a placebo device that looks identical but emits no therapeutic light. Treatments involve positioning the device 3 to 4 inches from the skin over the TMJ area, applying laser therapy for 16 minutes total, with 8 minutes on each side. Participants are randomly assigned to receive either the active device or placebo in a triple-blind design. Participants will undergo assessments of pain using a visual analog scale (VAS) and mouth opening measurements before and immediately after treatment. The primary outcome is the number of participants achieving a 30% or greater reduction in pain rating. The study includes adults aged 22 to 75 with ongoing jaw pain lasting at least three months. Safety and effectiveness will be monitored throughout the trial, which runs until December 2027.

This research aims to evaluate a freezing technique called cryoneurolysis to see if it helps reduce pain in adults with trigeminal neuralgia, a condition causing severe facial pain. The study is a randomized, triple-blinded trial comparing the freezing treatment with a sham procedure to determine its safety and effectiveness. Researchers want to find out how many participants experience at least a 75% reduction in pain and will also collect other important information about pain relief and side effects. Participants will be randomly assigned to either receive the cryoneurolysis treatment or a sham stimulation device. Before treatment, all participants will keep a daily headache diary for two weeks. After treatment, they will continue recording pain for four weeks. Following this initial period, there is an extension phase lasting up to two years where all participants can receive treatment as needed. The study involves careful monitoring of pain levels and any treatment-related adverse events during weeks 1 to 4 post-intervention. During the study, participants will have their pain recorded daily using pain scales and diaries. Researchers will evaluate average daily pain intensity, responder rates based on various pain and impression scales, and safety outcomes. The study includes baseline and follow-up assessments to compare pain levels before and after treatment. Participants' ability to maintain their usual medication regime is required, and safety monitoring will continue throughout the study period. Total participation time can last up to two years with long-term follow-up opportunities.

Researchers are investigating nerve involvement in patients with essential trigeminal neuralgia, a common type of facial pain that can be resistant to medication and disabling treatments. This study aims to improve the diagnosis and surgical decision-making by using advanced MRI techniques, including diffusion tensor imaging (DTI) and resting state functional MRI (fMRI), in addition to standard anatomical MRI. The study is prospective and involves patients referred for neurosurgery or pain management for unilateral essential trigeminal neuralgia. Participants will undergo a specialized MRI exam using a 3 Tesla machine that includes standard anatomical sequences with contrast injection, a diffusion tensor imaging sequence to analyze nerve fibers, and a resting state functional MRI to examine brain connectivity. The total MRI scan lasts about 45 minutes, with the added sequences taking approximately 15 minutes. This imaging approach is designed to better characterize nerve damage and vascular conflicts that may influence treatment. During the study, researchers will assess micro-structural changes in the trigeminal nerve at the time of inclusion. Patients will receive the MRI exam as part of their evaluation, and the imaging results will be used to guide treatment decisions. The study will monitor how these imaging techniques correlate with nerve involvement and surgical outcomes, helping to improve future diagnosis and management of trigeminal neuralgia.

Researchers are evaluating the effectiveness of an endoscopically guided injection of Exparel (Bupivacaine) for treating craniofacial pain conditions such as migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglion neuralgia, and paroxysmal hemicrania. This Phase 2 prospective, randomized, double-blinded, placebo-controlled, and crossover study aims to determine whether injecting Exparel into the lateral nasal wall can improve pain and functional outcomes in patients who respond to topical Lidocaine during ENT endoscopy. Participants receive either an injection of Exparel (Bupivacaine Liposome), a non-opioid pain reliever, or a saline placebo through an endoscopic procedure targeting the ipsilateral pterygopalatine fossa. The study administers a single dose of 3cc bilaterally. The trial involves a crossover design where patients receive both treatments in different periods to compare effects. During the study, pain scores and associated symptoms will be monitored from baseline through day 21 to assess changes. Participants will attend clinic visits at the Stanford Pain & ENT Clinic, where their pain and functional outcomes will be evaluated. The total participation period includes assessments up to 21 days after treatment, with safety and symptom monitoring throughout. The study excludes pregnant women, those allergic to bupivacaine, and individuals unable to consent or participate fully.

This research aims to evaluate the safety and effectiveness of percutaneous peripheral nerve stimulation in adults experiencing peripheral neuropathic pain, including conditions such as postherpetic neuralgia and trigeminal neuralgia. The study seeks to answer whether this nerve stimulation method can reduce pain and whether it is safe for patients. It is conducted as a randomized withdrawal trial involving multiple clinical sites. Participants will undergo implantation of a peripheral nerve stimulation electrode device produced by Jiangsu CED Medtech Co., Ltd. After implantation, their pain levels are monitored, and those with at least a 30% reduction in pain scores are randomly assigned to receive either active stimulation or placebo stimulation during a randomized withdrawal period. The study includes an enrollment and baseline period, a treatment period consisting of test, randomized withdrawal, and observation subperiods, and a follow-up period. The device remains implanted for 28 days, after which it is removed. Throughout the study, participants will keep a pain diary recording daily pain scores using the Visual Analogue Scale (VAS), report analgesic medication use, number of awakenings, and any adverse events. Researchers will perform assessments including physical exams, vital signs, laboratory tests, and questionnaires on neuropathic pain and quality of life. Pain scores and other measures are recorded daily during various study phases and at follow-up visits to assess the intervention's impact and safety.

Researchers are investigating whether online or group physiotherapy is as effective as individual physiotherapy for treating myogenic temporomandibular disorders (TMDs), which cause orofacial pain. The study addresses the challenge that few dentists and physiotherapists specialize in this area, leading to long wait times for treatment. The aim is to ensure patients receive safe and effective care, especially given the abundance of unverified information available online. Participants are randomly assigned to one of three groups: online physiotherapy, group physiotherapy, or individual physiotherapy. The online group receives a detailed exercise video available for four weeks. The group physiotherapy group attends a 30-minute face-to-face session with up to five people, learning exercises before practicing at home for four weeks. The individual physiotherapy group has a one-on-one 30-minute session to learn exercises, followed by four weeks of home practice. During the study, pain levels will be measured using a Visual Analogue Scale before and one month after physiotherapy. Additional assessments include RDC/TMD results after one month. Participants will be monitored throughout the treatment period, which lasts four weeks. The study aims to provide evidence on the best physiotherapy approach for TMDs, helping to improve access and treatment quality for patients.

Researchers are evaluating the effectiveness and safety of Pulsed Radiofrequency (PRF) compared to a combination of Pulsed and Thermal Radiofrequency (PRF + TRF) for treating adults with Trigeminal Neuralgia, a chronic condition causing intense facial pain. The study aims to find out which treatment provides better long-term pain relief and reduces the need for pain medication while monitoring complication rates. Participants will be randomly assigned to one of two groups. One group will receive PRF treatment targeting the trigeminal nerve using electrical pulses without causing thermal damage. The other group will receive PRF combined with thermal lesioning at 60-70°C to the nerve. Both procedures are performed under sterile conditions with monitoring and anesthesia. Participants will be followed for 12 weeks after treatment with assessments at 1, 4, and 12 weeks. Researchers will measure pain relief using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS), track changes in medication use, and record any procedure-related adverse events. This follow-up helps understand the treatments' effects on pain and safety over time.

Researchers are evaluating the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating adults aged 18 to 60 with idiopathic trigeminal neuralgia (TN). This condition involves severe, recurring facial pain, and the study aims to determine which imaging method provides better pain relief, affects medication use differently, and has fewer procedure-related side effects. Participants will be randomly assigned to receive either CT-guided TG-RFT, which uses real-time CT imaging to guide needle placement, or fluoroscopy-guided TG-RFT, which uses fluoroscopic imaging. Both procedures are done under sterile conditions with appropriate monitoring and anesthesia. After the procedure, participants will be followed for pain relief and side effects at 1, 3, and 6 months. During the study, participants will undergo pain assessments using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) at several time points including baseline, immediately after the procedure, and during follow-up visits. Medication use will be tracked at 6 months, and any procedure-related adverse events will be recorded throughout. The total involvement spans the procedure and follow-up assessments over six months.

Researchers are evaluating a new approach called deep brain stimulation for patients with refractory trigeminal neuralgia caused by a pontine lesion, often seen in multiple sclerosis. These patients suffer from severe facial pain that does not respond to current medical or surgical treatments. The goal is to explore if this novel technique can help control pain by targeting the lesion involved in pain signal generation. The study involves implanting a deep brain stimulation lead directly within the pontine lesion to modulate pain signals. This is a Phase 1 pilot trial where the intervention consists of this device implantation procedure. There is only one treatment group receiving the deep brain stimulation device. Participants will be followed for 24 months to assess whether the procedure can be completed as planned without deviations, the accuracy of lead placement, changes in pain levels, facial numbness, any complications, quality of life changes, patient acceptance of the procedure, and overall patient impression of improvement. The study aims to monitor safety and feasibility over this two-year period.

Researchers are evaluating the clinical effectiveness of chlorzoxazone compared to orphenadrine citrate for relieving orofacial pain in people who grind their teeth (bruxism). The study is a randomized clinical trial involving 60 patients over 15 years old who have orofacial and temporomandibular pain but no chronic systemic illnesses. The goal is to assess how well each drug reduces pain severity and improves temporomandibular joint function. Participants are randomly assigned to one of two groups: one group receives chlorzoxazone twice daily for two weeks, while the other group receives orphenadrine citrate on the same schedule. Both treatments are taken orally. Pain severity is measured using the Visual Analogue Scale (VAS) at the start, after 7 days, and after 14 days. A temporomandibular joint evaluation form is also used before and after treatment to assess joint parameters. During the study, participants will undergo pain assessments and joint evaluations at specified intervals. Researchers will monitor changes in orofacial pain scores from baseline to the end of treatment at two weeks. Statistical analysis will be conducted to compare the effects of the two drugs. The study is sponsored by the University of Baghdad and aims to provide detailed information on managing bruxism-related pain.