Clinical Research Directory

Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic CMPS?

The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine. The mesotherapy procedure will be performed five times, at weekly intervals. Blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.

Comparing Physical Therapy Interventions on Craniovertebral Angle (CVA) in Cervical Myofascial Pain Syndrome (MPS)

Myofascial pain syndrome (MPS) and radiculopathy are prevalent musculoskeletal conditions that afflict a substantial portion of the population, causing significant discomfort and impairments in daily functioning. MPS is characterized by localized muscle pain, trigger points, and referred pain, often accompanied by stiffness and restricted range of motion. A common feature shared by individuals with MPS and radiculopathy is the presence of postural abnormalities and balance impairments . The craniovertebral angle, which reflects the relationship between the head and neck, is often compromised in these individuals due to muscle imbalances, pain-related guarding, and structural changes in the spine. Various physiotherapy modalities, including dry needling, manual mobilization and soft tissue release, trigger point therapy, stretching, cupping therapy, and electrotherapy, have been utilized in clinical practice, but their relative efficacy in improving the craniovertebral angle and alleviating symptoms in individuals with MPS and radiculopathy has not been comprehensively compared. Understanding the underlying mechanisms and comparative effectiveness of various physiotherapy interventions is essential for guiding evidence-based clinical decision-making and optimizing treatment outcomes for individuals with MPS and radiculopathy. By elucidating the effects of different treatment modalities on the craniovertebral angle and associated outcomes, this research endeavor aims to contribute to the development of more tailored and effective physiotherapy approaches for improving the well-being of individuals affected by these debilitating musculoskeletal conditions.

Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome

Sonodyn is an investigational device that within this clinical investigation is intended for use in patients suffering from low back pain, tension headache or neck pain, originating from therapy-resistant myofascial pain syndrome. Myofascial pain syndrome is a prevalent pain condition in the adult population and a common cause of pain and dysfunction in the musculoskeletal system. It is a trigger point-induced regional musculoskeletal pain disorder affecting one or more muscles or groups of muscles. Sonodyn is a handheld medical device that combines low-energy ultrasound, electrical and magnetic field stimulation for non-invasive transcutaneous treatment of chronic myofascial pain syndrome. Sonodyn is a battery-operated, rechargeable stimulation device to be placed over specific trigger points for associated pain patterns in the human body. It emits ultrasound, electrical and magnetic stimulation signals with a pre-defined set of parameters for each of the independently operated power sources. The study will follow a prospective, randomized, sham-controlled, double-blind parallel group design. It will be conducted as a multi-center investigation at 6 sites in Austria and Switzerland. Patients are randomized in a 2:1 ratio into Treatment and Control. * Active Sonodyn therapy (Treatment) * No therapy (Sham Control) Two types of Sonodyn devices will be used: a fully functional one for Therapy arm patients that can deliver stimulation, and a non-functional one for Control arm patients that cannot convey any energy signals to the device output. The devices will look fully identical. Randomization will be stratified by study site, pain diagnosis and sex of the patient. For each subject, after a screening phase of 1 week, patients will be treated for 3 weeks with a follow-up of additional 8 weeks, adding up to 12 weeks. During treatment patients will activate their device 3 times a day for 10 minutes each. During screening, treatment and follow-up period, all patients will twice per day report the average and maximum intensity of their pain Numeric Rating Scale (NRS). Patients will also enter the date, amount, and time of intake of rescue medication, if applicable. The primary objective of this study is to assess the impact on pain. Secondary objectives are to compare the performance between active therapy and sham, as well as to correlate changes in pain intensity with other pain related scales.