MedTrace Logo

Safety and Efficacy of Repetitive Peripheral Magnetic Stimulation in Patients With Achilles Tendinopathy

NCT04221711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-07

No results posted yet for this study

Summary

With this prospective, randomized, controlled trial the investigators want to investigate effects of a prolonged repetitive Peripheral Magnetic Stimulation (rPMS) intervention on Achilles tendinopathy and compare it to a well established intervention. This may provide clinicians with a new, non-pharmacological, non-invasive, near painless approach to treat tendinopathy.

Although promising results with comparable devices exist, a direct and valid conclusion on the overall clinical performance of the investigational device cannot be drawn. This is mainly due to different treatment protocols used in the literature and due to the lack of insight in the technical documentation of comparable devices. Further, the applied magnetic fields vary in their amplitude, frequency, waveform and/or stimulation durations.

Therefore, the main goal of this clinical investigation is the collection of clinical data on the clinical performance of the investigational device. This clinical data will subsequently serve as a main source for the clinical evaluation of the medical device.

Conditions

  • Achilles Tendinopathy

Interventions

DEVICE

Repetitive pulsed magnetic stimulation

OMNITRON ProMed is a rPMS (repetitive peripheral magnetic stimulation) device used for deep stimulation of muscles and/or neurones (outside the brain). The energy is delivered by way of a special round treatment coil, whose cover material is tested for biocompatibility. The OMNITRON ProMed device produces a high-energy impulse field and stimulates tissue, in particular soft tissue, muscles and neurons, by means of repetitive peripheral magnetic stimulation (rPMS). Short, extremely strong magnetic fields in the microsecond range are emitted non-invasively. OMNITRON ProMed works with short-term energy emission at a peak power of up to 60 million watts and a magnetic field strength of up to 100 milliTesla. The intensity of treatment can be set between 20 and 100 %. The device automatically adjusts the magnetic field strength and the frequency of the pulses emitted depending on the intensity selected. For comfortable transport and application the product is compact and portable.

PROCEDURE

Eccentric Calf Muscle Training for Achilles Tendinopathy

Patients will be asked to stand with their full body weight on the injured leg. From an upright body position and standing with all body weight on the forefoot and the ankle joint in plantar flexion, the calf muscle is then loaded by having the patient slowly lower the heel beneath the forefoot. The calf muscle will only be loaded eccentrically, not concentric. Instead, the non-injured leg is used to get back to the start position. The first set of this exercise is performed in an upright position, followed by a second set with the knee bent to 45°. This regimen is performed 2x per day. The patients are told to go ahead with the exercise even if they experienced pain. However, they are told to stop if the pain becomes disabling.

Sponsors & Collaborators

  • Gesundheitszentrum Woergl

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2021-09-04
Completion
2021-09-04

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221711 on ClinicalTrials.gov