Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome - Lower Back focused on measuring Myofascial Pain Syndrome, Low-Energy Stimulation, Ultrasound, Electrical and Magnetic Field Stimulation, Transcutaneous Pain Therapy, Chronic Pain
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 99 years at screening 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 Patient is suffering from one of the following chronic pain conditions originating from myofascial pain: low back pain tension headache neck pain having been persisting for a minimum of 3 months and where myofascial pain syndrome is the pre-dominant cause for pain. Patient is constant with respect to pain treatment for 1 week during the screening phase A daily average NRS >= 4 on 4 out of 7 days in the screening phase Compliance with the daily status reporting requirements as demonstrated Exclusion Criteria: Patients with active implants Allergy against rescue medication used during the study Pregnancy Mental or physical impairments that represent a source of risk for handling the device Patients with cerebral spams (epilepsy) Patients with psychiatric diseases or somatoform pain disorders Patients with oral morphine equivalent of more than 120mg daily dose Patients taking centrally acting muscle relaxants like Sirdalud or benzodiacepines Patients with a contraindication against NSAID's Presence of artificial joints made from methylmethacrylate or polyethylene at stimulation site Presence of ferromagnetic metal implants at stimulation site, especially aneurysm clips, dental implants, etc.
Sites / Locations
- Schmerzambulanz, Krankenhaus der Elisabethinen GrazRecruiting
- Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am WörtherseeRecruiting
- Krankenhaus St. Vinzenz ZamsRecruiting
- RSB Neurochirurgie AG, Salem-Spital BernRecruiting
- Clinique de la Douleur, La Tour HospitalRecruiting
- Schmerzklinik Zürich AGRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active Sonodyn Therapy (Treatment Group)
Sham Therapy (Control Group)
Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.
Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.