[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myofascial-pain-syndrome---lower-back\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myofascial-pain-syndrome---lower-back":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100504668","low-energy-ultrasound-electrical-and-magnetic-field-stimulation-in-therapy-resistant-myofascial-pain-syndrome-100504668",false,"NCT05851326","Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome","A Combination of Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Patients With Therapy-Resistant Myofascial Pain Syndrome: A Randomized, Controlled, Double-Blind Multi-Center Study","Inclusion Criteria:\n\n* Male or female aged 18 to 99 years at screening\n* Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures\n* Patient is suffering from one of the following chronic pain conditions originating from myofascial pain:\n\n  * low back pain\n  * tension headache\n  * neck pain\n\nhaving been persisting for a minimum of 3 months and where myofascial pain syndrome is the pre-dominant cause for pain.\n\n* Patient is constant with respect to pain treatment for 1 week during the screening phase\n* A daily average NRS \\>= 4 on 4 out of 7 days in the screening phase\n* Compliance with the daily status reporting requirements as demonstrated\n\nExclusion Criteria:\n\n* Patients with active implants\n* Allergy against rescue medication used during the study\n* Pregnancy\n* Mental or physical impairments that represent a source of risk for handling the device\n* Patients with cerebral spams (epilepsy)\n* Patients with psychiatric diseases or somatoform pain disorders\n* Patients with oral morphine equivalent of more than 120mg daily dose\n* Patients taking centrally acting muscle relaxants like Sirdalud or benzodiacepines\n* Patients with a contraindication against NSAID's\n* Presence of artificial joints made from methylmethacrylate or polyethylene at stimulation site\n* Presence of ferromagnetic metal implants at stimulation site, especially aneurysm clips, dental implants, etc.","ALL","18 Years","99 Years",{"count":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nMyofascial 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.\n\nSonodyn 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.\n\nThe 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.\n\n* Active Sonodyn therapy (Treatment)\n* No therapy (Sham Control)\n\nTwo 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.\n\nRandomization will be stratified by study site, pain diagnosis and sex of the patient.\n\nFor 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.\n\nDuring 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.\n\nThe 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.",[27,28,29],"Myofascial Pain Syndrome - Lower Back","Myofascial Pain Syndrome - Neck","Myofascial Pain Syndrome - Tension Headache",[31,32,33,34,35],"Myofascial Pain Syndrome","Low-Energy Stimulation","Ultrasound, Electrical and Magnetic Field Stimulation","Transcutaneous Pain Therapy","Chronic Pain","RECRUITING","2026-04-21",{"date":39,"type":40},"2026-04-23","ACTUAL",{"date":42,"type":40},"2023-05-25",{"date":44,"type":21},"2027-06",{"name":46,"class":47},"Sobet AG","INDUSTRY",6,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100614359","magnetic-resonance-elastography-to-monitor-response-to-manual-therapy-in-myofascial-pain-100614359","NCT07278570","Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain","Inclusion Criteria:\n\n* Adult males or females (age ≥ 18 years)\n* A history of chronic low back for at least 3 months. (Measured by patient history and physical exam)\n* A palpable taut band or nodule within the skeletal muscle\n* Hypersensitive tender spot within the taut band\n* Recognition of current pain complaint by pressure on the tender nodule\u002Ftaut band\n* Painful limit to the full stretch range of motion\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan\n* Previous therapy in the area to be treated within 3 months\n* Previous severe back injury (including fracture) or surgery\n* Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation\u002Fpain perception\n* Severe osteoarthritis\n* Skin injuries in the area to be treated\n* Inability to provide consent.",{"count":56,"type":21},78,[24],"The purpose of this research is to develop and test new Magnetic Resonance Imaging (MRI) methods that look at how muscles and tissues under the skin (myofascial tissues) move and respond to pressure. The investigators want to see how these tissues differ between healthy people and people with pain or injury, and how they change after hands-on treatment (Tuina therapy). The results will also be compared to a group that receives standard care without Tuina therapy.\n\nThe main questions this study aims to answer are:\n\n1. Can MR elastography (MRE) show changes in how the fascia and the layers between muscles move and stretch before and after manual therapy?\n2. Do changes seen on MRE scans match changes in pain, function, and other symptoms reported by participants?\n3. Can MRE measurements before treatment help predict which participants are most likely to improve with manual therapy?\n\nIn this randomized controlled trial, participants with myofascial pain will be randomly assigned (randomized) to either the Tuina group or the Usual Care group following a home-based care program without manual therapy. All treatments are noninvasive, hands-on techniques commonly used in clinical practice to reduce tissue tightness and improve movement.\n\nParticipants will be asked to undergo three MRI scans and to complete questionnaires and other standard clinical assessments about their pain, physical function, and quality of life.",[27,60],"Myofascial Pain","2026-02-02",{"date":63,"type":40},"2026-02-03",{"date":65,"type":40},"2026-02-01",{"date":67,"type":21},"2027-08-30",{"name":69,"class":70},"Mayo Clinic","OTHER"]