Clinical trials

Migraine is one of the most prevalent primary headache disorders worldwide and is associated with substantial impairments in quality of life, work productivity, and psychosocial functioning. In Germany alone, nearly 18 million people are affected. Although pharmacological therapy remains a cornerstone of migraine management, non-pharmacological interventions-particularly physiotherapy-play an important role in multimodal treatment concepts and are generally well tolerated. Recent evidence suggests that physiotherapy for migraine should extend beyond conventional manual techniques and include patient education, aerobic endurance training, and self-management strategies. However, in routine clinical practice, physiotherapeutic approaches vary widely and are often not fully aligned with current evidence-based recommendations. Moreover, there is a lack of pragmatic randomized controlled studies evaluating the effectiveness of structured, evidence-based multimodal physiotherapy compared with conventional physiotherapy under real-world clinical conditions. This study is a randomized controlled pilot trial designed to compare an evidence-based multimodal physiotherapeutic intervention with conventional physiotherapy in adult patients with migraine. The multimodal intervention consists of evidence-based physiotherapy, structured patient education on migraine and pain mechanisms, guided moderate aerobic endurance training, and relaxation techniques. The control group receives conventional physiotherapy according to German standard clinical practice. The study is designed as a randomized controlled trial with a pre-post design. Adult patients aged 18 to 60 years with a specialist-confirmed diagnosis of migraine will be recruited from a specialized pain therapy center in Osnabrück, Germany. Participants will be randomly allocated to either the multimodal treatment group or the usual care physiotherapy group. The intervention period lasts three months. The primary outcome is migraine-related quality of life measured using the Headache Impact Test (HIT-6™). Secondary outcomes include headache frequency and intensity assessed via headache diaries, migraine-related work absenteeism, and functional impairment. Feasibility outcomes will be evaluated through the feasibility and acceptance of the multimodal treatment program from the perspective of the treating physiotherapists. The results are expected to provide robust evidence on the effectiveness and real-world applicability of multimodal treatment programs compared with usual care for migraine management in Germany. Embedded to this project there is also the prediction analysis. For that patients will be divided into those who responded to the treatment and those who stay stable or get worse after treatment. Based on that a statistical analysis will be used to assess which factors influenced the improvement of those patients after physical therapy treatment.

Many people experience long-lasting neck pain, which can affect daily life, work, and overall well-being. This study aims to find out which type of exercise program is most effective in reducing neck pain, improving neck movement, and making daily activities easier. What Is Being Studied?: The study compares three different types of treatment: DNS Exercises (Dynamic Neuromuscular Stabilization): Whole-body exercises focusing on posture, breathing, and core stability. Localized Neck Exercises: Targeted exercises for the neck and shoulder muscles. Standard Care: Usual physiotherapy treatment commonly provided in clinical practice. Study Procedures: Participants are randomly assigned to one of the three groups. Each participant receives individual exercise instruction from a physiotherapist. Participants are also given simple home exercises to perform on their own. The study lasts for about 12 weeks. What Will Be Measured?: At the beginning, during, and at the end of the study, the following will be assessed: Neck pain intensity (pain scale) Neck range of motion How much the pain affects daily life and activities Possible Benefits: Participants may experience: Less neck pain Improved neck mobility Better overall body awareness Even if not every participant notices improvement, taking part will help researchers improve future treatment options for chronic neck pain. Risks: No major risks are expected. All exercises are supervised by qualified physiotherapists and adjusted to each participant's abilities. Participation can be stopped at any time if discomfort or pain occurs. Voluntary Participation and Data Privacy: Participation is completely voluntary. All personal data will be kept confidential and analyzed anonymously for research purposes only. Participants may withdraw from the study at any time without any disadvantages.

Musculoskeletal (MSK) disorders are some of the most burdensome health issues in the world and the leading causes of years living with a disability. Between them, jaw pain and neck have been very prevalent among the general population. Subjects with chronic neck and jaw pain present with persistent pain, allodynia, and hyperalgesia, sometimes extending to regions distant from the neck, head, or face, as well as cognitive and motor dysfunction. In addition, both conditions are commonly related to pain in other anatomical regions, and they also might also exhibit a greater risk for pain-associated somatic symptom burden. The treatment for patients with neck and jaw could involve different techniques in the rehabilitation area. Between them, therapeutic exercise is a cornerstone of MSK disease rehabilitation. Although mechanisms of action for exercise in subjects with pain are not yet understood, therapeutic exercise is widely applied in a variety of painful MSK conditions, such as low back pain, shoulder pain, knee pain, osteoarthritis, and disorders of the cervical and craniofacial regions such as temporomandibular disorders, headaches, and neck pain. Besides its effects on function and health, therapeutic exercise is known to have some pain-relieving effects and specific motor control exercises targeted to the neck can enhance the neural control of the cervical spine in patients with neck involvement such as patients with jaw and neck pain. Previous studies have demonstrated that treatment directed to the neck may be beneficial in decreasing pain intensity in the masticatory muscles, increasing pain-free mouth opening, and decreasing pain in the head and neck regions in people with jaw pain. In addition, neck motor control exercises have been successful to manage chronic neck pain and cervicogenic headache. Subjects with neck pain and associated disorders receiving neck motor control exercises had a reduction of pain and improved quality of life. Another option that has been explored to relieve MSK pain is aerobic exercise. Aerobic exercise has been used to stimulate the release of pain-relieving peptides in healthy human beings; however, little is known about the analgesic effect of exercise in people suffering from actual musculoskeletal pain. Previous literature found positive results in favor of aerobic exercise for pain relief. However, none of them included patients with jaw and neck-related disorders. Therefore, the aim of the present pilot randomized controlled trial (RCT) is to test the effectiveness of local craniocervical motor control exercises when compared with aerobic exercise on pain-disability related outcomes such as pain intensity, pain pressure thresholds (PPTs), jaw and neck disabilities and to restore normal muscular performance and fatigability of the cervical muscles in people with jaw and neck pain. Also, an important objective for performing this pilot study is to test the feasibility of these protocols and gather data that will be the basis for applying to external funding. This study will be a randomized controlled trial, blinded, two-armed parallel group. It will include women between 18-60 years of age; diagnosed with temporomandibular disorders (i.e., jaw pain) classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); or diagnosed with idiopathic chronic neck pain associated or not with TMD. Because this is an exploratory (pilot) study it will include at least 21 subjects per treatment group. The primary outcome will be pain intensity evaluated by the Visual Analogue Scale (VAS), and the secondary outcomes will be Neck Disability Index; Jaw Function; Pressure Pain Threshold; Psychological functioning; Global Rating Scale; and Muscular performance and fatigability of the cervical muscles. The patients will be randomized into two groups: local craniocervical motor control exercises and aerobic exercise. The local craniocervical motor control exercises program will be focused on training the deep and superficial flexors and extensors neck muscles. The treatment will consist of a 12-week progressive training program with a total duration of 30-45 min per session. Individuals assigned to the aerobic exercise will receive cycling exercise, with a total duration of 60 minutes. Both groups will be evaluated before the treatment starts (baseline); after two and six weeks from the beginning of treatment (1st and 2nd partial evaluation); at the end of the treatment (final evaluation - 12 weeks); and after three and six months of the end of the treatment (1st and 2nd follow-up).