Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851326
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-05-01
Brief Title:
Low-Energy Ultrasound Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
Sponsor:
Sobet AG
Organization:
Sobet AG
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 21 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
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 21 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None