Headache

This research aims to evaluate the additional effects of sternocleidomastoid muscle release combined with suboccipital muscle release in managing cervicogenic headache, a condition caused by dysfunction in the C1-C2 vertebrae and marked by neck stiffness and limited neck rotation. Cervicogenic headache significantly impacts daily activities and is associated with forward head posture and weak deep neck muscles. The study is a randomized control trial conducted by Foundation University Islamabad to explore these manual therapy techniques alongside conventional physical therapy treatments. Participants are divided into two groups. Group A will receive suboccipital muscle release consisting of three repetitions of three minutes each (total 9 minutes), combined with conventional physical therapy including TENS and hot pack therapy for 10 minutes, six days a week for two consecutive weeks. Group B will receive sternocleidomastoid muscle release for 5 minutes plus the same suboccipital muscle release and conventional physical therapy schedule as group A. Both interventions are delivered over 12 sessions in total. During the study, participants will undergo assessments to measure pain intensity and range of motion after two weeks of treatment. Researchers will monitor headache symptoms, neck function, and muscle performance using clinical tests like the flexion rotation test. The study does not involve masking or blinding, and all participants will be adults aged 18 to 45 years. The total participation period includes the two-week treatment phase followed by outcome evaluations.

Researchers are conducting a large-scale observational study called the Italian Migraine Registry I-GRAINE-New to better understand migraine disorders. The study focuses on adults with episodic or chronic migraine who have recently visited specialized migraine centers. It aims to analyze the prevalence and characteristics of migraine types, the impact on daily life, treatment patterns, and healthcare resource use in Italy. This study involves enrolling patients consecutively at multiple centers, where they undergo a detailed clinical and neurological examination at baseline. Follow-up data will be collected during routine clinic visits over an average of two years to observe the natural history and care pathways of migraine once patients start specialist treatment. Participants will be assessed through clinical exams and structured interviews, including validated scales like MIDAS and HIT-6, to measure disability and disease influence. The study measures the size and awareness of the migraine problem in headache centers and tracks patients' treatment and healthcare use. Each patient's participation lasts about 24 months from their initial visit to the migraine center.

Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

Researchers are investigating treatments for temporomandibular disorders (TMD), which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups: one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Migraine is a common chronic neurological condition linked to patent foramen ovale (PFO), a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.

Researchers are evaluating and comparing the pain relief effects and safety of two oral migraine treatments, Rimegepant (Nurtec ODT) and Rizatriptan (Maxalt MLT-ODT), in adults experiencing acute migraine headaches. This randomized, double-blind trial is conducted in an urban emergency department setting with adult patients diagnosed with migraine without aura, seeking to determine which medication provides better pain relief within 60 and 120 minutes. Participants receive either Rimegepant 75 mg or Rizatriptan 10 mg orally disintegrating tablets during their emergency department visit. The study involves careful monitoring of headache intensity every 30 minutes for up to 120 minutes after medication. Patients who need additional pain relief after one hour may receive rescue medication as determined by their physician. The trial includes follow-up by phone 24 hours after discharge to assess headache status and treatment satisfaction. During the study, participants will rate their pain using a validated 11-point numerical scale and describe their headache severity and functional ability using standard categorical scales. Researchers will record demographic, medical, and vital sign data, and evaluate outcomes such as pain reduction at 60 minutes, use of rescue medication, sustained headache relief for 24 hours, and patient satisfaction with treatment. The total involvement includes the emergency visit and a phone follow-up 24 hours later.

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.

Researchers are studying whether a home-based virtual reality (VR) neurofeedback program is feasible and acceptable for adolescents aged 10 to 16 years with migraine. This trial aims to see if teenagers can be successfully enrolled, randomized, and retained while completing VR sessions and study procedures, and whether the program might improve migraine-related disability and symptoms. The study compares Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses brain activity recorded from a wearable EEG headband, with a VR program that shows immersive imagery without neurofeedback or relaxation training. Participants complete a 4-week baseline period involving headache logs, questionnaires, and a lab EEG assessment. Then they are randomly assigned to either the INSeRT neurofeedback VR or the comparison VR imagery program. Both groups do VR sessions at home three times a week, each lasting about 8 minutes, over 4 weeks. Questionnaires and a repeat EEG assessment are done after treatment and again approximately 3 months later. During the study, participants log headaches, complete questionnaires, and undergo EEG brain activity tests to measure changes. Researchers track recruitment, randomization, treatment adherence, retention, and symptom changes. Outcomes include the number and duration of VR sessions completed, treatment credibility, cybersickness symptoms, and migraine disability scores. Participants are followed for about 3 months after treatment to assess longer-term effects and safety.