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

Primary Purpose

Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active Sonodyn
Sham
Sponsored by
Sobet AG
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Sham Comparator

Arm Label

Active Sonodyn Therapy (Treatment Group)

Sham Therapy (Control Group)

Arm Description

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.

Outcomes

Primary Outcome Measures

Average Numeric Rating Scale (NRS)
Change in Treatment group from Baseline to EoT in average Numeric Rating Scale (NRS, 0-10, with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced) per day

Secondary Outcome Measures

Difference in average NRS between groups - Baseline to EoT
Difference between groups in change of average NRS from Baseline to EoT
Maximum NRS - Baseline to EoT
Change from Baseline to EoT in maximum NRS in both groups
Average and maximum NRS - Baseline to end of follow-up
Change from Baseline to end of follow-up in average and maximum NRS in both groups
AUC of average and maximum NRS - Baseline to EoT
Baseline-adjusted area under the curve (AUC) of average and maximum NRS from Baseline to EoT in both groups
Average and maximum NRS - Follow-up
Average and maximum NRS during follow-up in both groups
Medication consumption
Pain and rescue medication consumption during treatment and follow-up phase in both groups
EQ-5D-5L
EQ-5D-5L questionnaire from Baseline to EoT and end of follow-up
Quality of sleep
Quality of sleep questionnaire from Baseline to EoT and end of follow-up
Socioeconomic data
Change in socioeconomic data from Screening to EoT

Full Information

First Posted
May 1, 2023
Last Updated
June 12, 2023
Sponsor
Sobet AG
Collaborators
Klinikum Klagenfurt am Wörthersee, Krankenhaus der Elisabethinen Graz, Krankenhaus St. Vinzenz Zams, La Tour Hospital, Schmerzklinik Zürich, Salem-Spital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05851326
Brief Title
Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sobet AG
Collaborators
Klinikum Klagenfurt am Wörthersee, Krankenhaus der Elisabethinen Graz, Krankenhaus St. Vinzenz Zams, La Tour Hospital, Schmerzklinik Zürich, Salem-Spital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache
Keywords
Myofascial Pain Syndrome, Low-Energy Stimulation, Ultrasound, Electrical and Magnetic Field Stimulation, Transcutaneous Pain Therapy, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Sonodyn Therapy (Treatment Group)
Arm Type
Experimental
Arm Description
Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.
Arm Title
Sham Therapy (Control Group)
Arm Type
Sham Comparator
Arm Description
Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.
Intervention Type
Device
Intervention Name(s)
Active Sonodyn
Intervention Description
Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Non-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device.
Primary Outcome Measure Information:
Title
Average Numeric Rating Scale (NRS)
Description
Change in Treatment group from Baseline to EoT in average Numeric Rating Scale (NRS, 0-10, with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced) per day
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Difference in average NRS between groups - Baseline to EoT
Description
Difference between groups in change of average NRS from Baseline to EoT
Time Frame
3 weeks
Title
Maximum NRS - Baseline to EoT
Description
Change from Baseline to EoT in maximum NRS in both groups
Time Frame
3 weeks
Title
Average and maximum NRS - Baseline to end of follow-up
Description
Change from Baseline to end of follow-up in average and maximum NRS in both groups
Time Frame
11 weeks
Title
AUC of average and maximum NRS - Baseline to EoT
Description
Baseline-adjusted area under the curve (AUC) of average and maximum NRS from Baseline to EoT in both groups
Time Frame
3 weeks
Title
Average and maximum NRS - Follow-up
Description
Average and maximum NRS during follow-up in both groups
Time Frame
8 weeks
Title
Medication consumption
Description
Pain and rescue medication consumption during treatment and follow-up phase in both groups
Time Frame
11 weeks
Title
EQ-5D-5L
Description
EQ-5D-5L questionnaire from Baseline to EoT and end of follow-up
Time Frame
11 weeks
Title
Quality of sleep
Description
Quality of sleep questionnaire from Baseline to EoT and end of follow-up
Time Frame
11 weeks
Title
Socioeconomic data
Description
Change in socioeconomic data from Screening to EoT
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Safety Outcome #1
Description
Adverse Events (AEs), Adverse Device Effects (ADEs), and Device Deficiencies (DDs) observed until EoT
Time Frame
3 weeks
Title
Safety Outcome #2
Description
Serious Adverse Events (SAEs), Serious Adverse Device Effects (SADEs), and related AEs observed until end of follow-up
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Anguiano, Dr.
Phone
+49 1511 0177825
Email
lidia.anguiano@alirahealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Likar, Prof. Dr.
Organizational Affiliation
Klinikum Klagenfurt am Wörthersee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schmerzambulanz, Krankenhaus der Elisabethinen Graz
City
Graz
ZIP/Postal Code
8020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kern, Dr.
First Name & Middle Initial & Last Name & Degree
Michael Kern, Dr.
First Name & Middle Initial & Last Name & Degree
Julia Kolb, Dr.
Facility Name
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolf Likar, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Rudolf Likar, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Stefan Neuwersch-Sommeregger, Dr.
First Name & Middle Initial & Last Name & Degree
Markus Köstenberger, Dr.
Facility Name
Krankenhaus St. Vinzenz Zams
City
Zams
ZIP/Postal Code
6511
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Wolf, Dr.
First Name & Middle Initial & Last Name & Degree
Andreas Wolf, Dr.
First Name & Middle Initial & Last Name & Degree
Christian Wolf, Dr.
Facility Name
RSB Neurochirurgie AG, Salem-Spital Bern
City
Bern
ZIP/Postal Code
3013
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Binggeli, Dr.
First Name & Middle Initial & Last Name & Degree
Ralph Binggeli, Dr.
First Name & Middle Initial & Last Name & Degree
Bernhard Voller, Prof. Dr.
Facility Name
Clinique de la Douleur, La Tour Hospital
City
Meyrin
ZIP/Postal Code
1217
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Perruchoud, PD Dr.
First Name & Middle Initial & Last Name & Degree
Christophe Perruchoud, PD Dr.
First Name & Middle Initial & Last Name & Degree
Blaise Rutschmann, Dr.
Facility Name
Schmerzklinik Zürich AG
City
Zürich
ZIP/Postal Code
8050
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hartmann, Dr.
First Name & Middle Initial & Last Name & Degree
Michael Hartmann, Dr.
First Name & Middle Initial & Last Name & Degree
Tomislav Kovacevic, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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