Clinical trial NCT05851326: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Sobet AG
Sponsor class: INDUSTRY
Collaborators: name: Klinikum Klagenfurt am Wörthersee
name: Krankenhaus der Elisabethinen Graz
name: Krankenhaus St. Vinzenz Zams
name: La Tour Hospital
name: Schmerzklinik Zürich
name: Salem-Spital Bern
First posted: 2023-05-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Average Numeric Rating Scale (NRS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Difference in average NRS between groups - Baseline to EoT
timeFrame: 3 weeks
measure: Maximum NRS - Baseline to EoT
timeFrame: 3 weeks
measure: Average and maximum NRS - Baseline to end of follow-up
timeFrame: 11 weeks
measure: AUC of average and maximum NRS - Baseline to EoT
timeFrame: 3 weeks
measure: Average and maximum NRS - Follow-up
timeFrame: 8 weeks
measure: Medication consumption
timeFrame: 11 weeks
measure: EQ-5D-5L
timeFrame: 11 weeks
measure: Quality of sleep
timeFrame: 11 weeks
measure: Socioeconomic data
timeFrame: 4 weeks
Other outcomes:
measure: Safety Outcome #1
timeFrame: 3 weeks
measure: Safety Outcome #2
timeFrame: 11 weeks
Locations:
city: Graz
country: Austria
facility: Schmerzambulanz, Krankenhaus der Elisabethinen Graz
city: Klagenfurt
country: Austria
facility: Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
city: Zams
country: Austria
facility: Krankenhaus St. Vinzenz Zams
city: Bern
country: Switzerland
facility: RSB Neurochirurgie AG, Salem-Spital Bern
city: Meyrin
country: Switzerland
facility: Clinique de la Douleur, La Tour Hospital
city: Zürich
country: Switzerland
facility: Schmerzklinik Zürich AG
Study officials:
affiliation: Klinikum Klagenfurt am Wörthersee
name: Rudolf Likar, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: