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New treatment option for Myofascial Pain Syndrome - Lower Back
Official title Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
ClinicalTrials.gov ID: NCT05851326
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- Patient is suffering from one of the following chronic pain conditions originating from myofascial pain:
- low back pain
- tension headache
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Klagenfurt, Austria
- Zams, Austria
- Bern, Switzerland
- Meyrin, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Klagenfurt, Austria; Zams, Austria; Bern, Switzerland; Meyrin, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.