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

NCT04221711 | Unknown DMC

• 1 other identifier: RPS001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tendinopathy; Achilles; Repetitive Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  Change of the experience of pain and functionality as assessed by the Victorian Institute of Sports Assessment questionnaire (VISA-A). The VISA-A questionnaire is a validated questionnaire with good test-retest, intra-rater and inter-rater reliability and is especially designed for patients with Achilles tendinopathy. The maximum score that can be achieved on the question is 100, and would be the score of person who is completely asymptomatic. A lower score indicates more symptoms and greater limitation of physical activity.

  "Week 0", "Week 12"

• Change of the experience of pain at exertion as assessed by the Visual Analogue Scale (VAS)

  Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("no pain"), 100 means high (Pain as bad as could possibly be).

  "Week 4", "Week 12"

• Percentage of participants with an anticipated adverse event of special interest

  Percentage of participants with an anticipated adverse event of special interest (muscle twitching, local warming and initial pain excitement). The occurrence of the expected side-effects is not definitely clear based on literature and pre-clinical investigations.

  "Week 4"

Secondary Outcomes (30)

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  "Week 0", "Week 2"

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  "Week 0", "Week 4"

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  "Week 0", "Week 6"

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  "Week 0", "Week 8"

• Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)

  "Week 0", "Week 24"

Study Arms (2)

Repetitive pulsed magnetic stimulation

EXPERIMENTAL

Patients randomized in this group will receive rPMS (80 milliTesla ; 2 Hertz; OMNITRON® promed; Healthfactories Holding GmbH) three times a week for a total of 12 weeks. Thereby they will be lying in a prone position or sitting for 20 minutes with the magnet coil positioned over the mid-portion of the affected Achilles tendon (manufactures instruction).

Device: Repetitive pulsed magnetic stimulation

Eccentric Calf Muscle Training for Achilles Tendinopathy

ACTIVE COMPARATOR

Two types of eccentric exercises will be used. The calf muscle will be eccentrically loaded both with the knee straight and with the knee bent. Each of the two exercises will include an increasing number of repetitions (1. Week, 2-3 weeks, 4-12 weeks) done in 3 sets (e.g. 3x15, 3x20, 3x30 repetitions). The patients will be informed that muscle soreness during the first 1 to 2 weeks of training was to be expected. Patients will receive a visual exercise protocol.

Procedure: Eccentric Calf Muscle Training for Achilles Tendinopathy

Interventions

Repetitive pulsed magnetic stimulation DEVICE

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.

Repetitive pulsed magnetic stimulation

Eccentric Calf Muscle Training for Achilles Tendinopathy PROCEDURE

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.

Eccentric Calf Muscle Training for Achilles Tendinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and non-pregnant women aged 18-60 years
• Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 12 weeks (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation).
• VISA-A score less than 65 at baseline.
• Be informed of the nature of the study and provide written informed consent.

You may not qualify if:

• Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
• Clinical suspicion of an Achilles tendon rupture.
• Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
• Severe foot deformity
• Condition that prevents the patients from executing an active exercise program
• Pregnant or lactating females
• History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs
• Persons with electronic implants (e.g. pacemaker, cochlear implants, drug pump, deep brain stimulator, etc.)
• Patients with organ transplants
• Patients with closed, circular metal implants (e.g. subdermal implants, etc.)
• Epilepsy

Sponsors & Collaborators

• Gesundheitszentrum Woergl: lead

Study Sites (1)

Gesundheitszentrum Woergl

Wörgl, Tyrol, 6300, Austria

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Central Study Contacts

Andreas Traweger, Prof.Dr.

CONTACT

+43(0)69910763674; traweger@healthfactories.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since blinding is not possible for patients, only the statistician will be blinded with respect to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design was chosen to be a randomized, controlled trial.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 9, 2020
• Study Start: September 4, 2020
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)