Achilles TendinopathyNCT04221711
Safety and Efficacy of Repetitive Peripheral Magnetic Stimulation in Patients With Achilles Tendinopathy
A study testing Repetitive pulsed magnetic stimulation and Eccentric Calf Muscle Training for Achilles Tendinopathy in people with Achilles Tendinopathy, run by Gesundheitszentrum Woergl at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Repetitive pulsed magnetic stimulation and Eccentric Calf Muscle Training for Achilles Tendinopathy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 4 Sep 2020to 4 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- Concomitant or previous participation in a clinical investigation within the last 3 months (wash out) prior to study inclusion
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Gesundheitszentrum Woergl
Wörgl, Tyrol, 6300
Stephan Papp, MD
About this study
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.
Read the detailed description
Tendons are collagenous tissues that link muscle to bone, and in best case, a painless transmission of force allows voluntary movement over a life time. Although tendons show long time underestimated repair and remodelling capacities, some of them (e.g. the human patellar or Achilles tendon) remain quite prone to injury. To make things worse, tendinous tissue reveals incomplete healing capacities and treatments seem to be ineffective to avoid the high injury recurrence rate and/or the occurrence of chronic tendon pain. Thus, both elite and recreational athletes, as well as the non-sporting population or workplace employees often suffer from symptoms like tendon swelling, localized tenderness, activity related pain and impaired performance, also known as tendinopathy. Such pain-induced restriction of mobility frequently means the end of a sporting carrier, deteriorates the quality of life and patients have to live with all harmful consequences of physical inactivity. One tendon most commonly afflicted by this debilitating musculoskeletal injury is the Achilles tendon. Although it is the strongest tendon in our body, the prevalence for tendinopathy can be as high as 56% among certain athletes.
The repetitive peripheral magnetic stimulation (rPMS) works through a deep operating, focused and painless stimulation mechanism generated by pulsed magnetic fields. This intervention is already successfully in use to accelerate the healing of bone fractures and to enhance the healing of operated rotator cuff tears. Additionally, data on in vitro tendon cells indicate the positive effect of rPMS on tendon tissue by stimulating cell proliferation, up-regulating tendon-specific gene expression and releasing anti-inflammatory cytokines and growth factors. More interestingly, intervention studies on the healing of rotator cuff tendon-to-bone injuries in rat models show increases in tendon stiffness and modulus and enhanced collagen organization, and type I collagen expression after prolonged rPMS without showing adverse effects in any mechanical or histological property. These results strongly support the hypothesis that rPMS might be effective in treating Achilles tendinopathy in humans. This intervention might reduce pain and functional limitations, reverse tendon degenerative changes and increase the impaired tendon mechanical and material properties.
- Conditions
- Achilles Tendinopathy
- Being tested
- Repetitive pulsed magnetic stimulation, Eccentric Calf Muscle Training for Achilles Tendinopathy
- Keywords
- Tendinopathy, Achilles, Repetitive Magnetic Stimulation
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive pulsed magnetic stimulationDevice
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.
Eccentric Calf Muscle Training for Achilles TendinopathyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Eccentric Calf Muscle Training for Achilles Tendinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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).
Measured: "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.
Measured: "Week 4"
Secondary outcomes (30)
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.
Measured: "Week 0", "Week 2"
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.
Measured: "Week 0", "Week 4"
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.
Measured: "Week 0", "Week 6"
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.
Measured: "Week 0", "Week 8"
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.
Measured: "Week 0", "Week 24"
Change of the experience of pain at exertion with 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).
Measured: "Week 0", "Week 2"
Change of the experience of pain at exertion with 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).
Measured: "Week 0", "Week 4"
Change of the experience of pain at exertion with 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).
Measured: "Week 0", "Week 6"
Change of the experience of pain at exertion with 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).
Measured: "Week 0", "Week 8"
Change of the experience of pain at exertion with 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).
Measured: "Week 0", "Week 24"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 0"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 2"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 4"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 6"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 8"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 12"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Psychometric response scale with continuous aspect (Visual Analogue Scale (VAS)). 0 means low ("not satisfied at all"), 100 means high (Satisfaction could not be higher).
Measured: "Week 24"
Change of Achilles transverse thickness
Maximum thickness will be recorded in the midportion of the affected Achilles tendon
Measured: "Week 0", "Week 6"
Change of Achilles transverse thickness
Maximum thickness will be recorded in the midportion of the affected Achilles tendon
Measured: "Week 0", "Week 12"
Change of Neovascularization in the Achilles tendon
Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.
Measured: "Week 0", "Week 4"
Change of Neovascularization in the Achilles tendon
Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.
Measured: "Week 0", "Week 12"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
The usability characteristics contribute to the summative evaluation of the usability of the device under investigation. 1 means low usability, 5 means high usability.
Measured: "Week 2"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
The usability characteristics contribute to the summative evaluation of the usability of the device under investigation. 1 means low usability, 5 means high usability.
Measured: "Week 8"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
The usability characteristics contribute to the summative evaluation of the usability of the device under investigation. 1 means low usability, 5 means high usability.
Measured: "Week 12"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 0"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 2"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 6"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 8"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 12"
Percentage of participants with an anticipated adverse event of special interest.
The 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.
Measured: "Week 24"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start4 Sep 2020 (estimated)
- Primary completion4 Sep 2021 (estimated)
- Study completion4 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design was chosen to be a randomized, controlled trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gesundheitszentrum Woergl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221711
- Sponsor's protocol ID
- RPS001
- Status last verified
- Sep 2020
- First submitted
- 2 Jan 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Repetitive Peripheral Magnetic Stimulation in Patients With Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT04221711
- Acronym / sponsor ID
- RPS001
- Conditions
- Achilles Tendinopathy
- Keywords
- Tendinopathy, Achilles, Repetitive Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gesundheitszentrum WoerglUniversity, hospital or other
- Study start
- 4 Sep 2020 (estimated)
- Primary completion
- 4 Sep 2021 (estimated)
- Study completion
- 4 Sep 2021 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tendons are collagenous tissues that link muscle to bone, and in best case, a painless transmission of force allows voluntary movement over a life time. Although tendons show long time underestimated repair and remodelling capacities, some of them (e.g. the human patellar or Achilles tendon) remain quite prone to injury. To make things worse, tendinous tissue reveals incomplete healing capacities and treatments seem to be ineffective to avoid the high injury recurrence rate and/or the occurrence of chronic tendon pain. Thus, both elite and recreational athletes, as well as the non-sporting population or workplace employees often suffer from symptoms like tendon swelling, localized tenderness, activity related pain and impaired performance, also known as tendinopathy. Such pain-induced restriction of mobility frequently means the end of a sporting carrier, deteriorates the quality of life and patients have to live with all harmful consequences of physical inactivity. One tendon most commonly afflicted by this debilitating musculoskeletal injury is the Achilles tendon. Although it is the strongest tendon in our body, the prevalence for tendinopathy can be as high as 56% among certain athletes.
The repetitive peripheral magnetic stimulation (rPMS) works through a deep operating, focused and painless stimulation mechanism generated by pulsed magnetic fields. This intervention is already successfully in use to accelerate the healing of bone fractures and to enhance the healing of operated rotator cuff tears. Additionally, data on in vitro tendon cells indicate the positive effect of rPMS on tendon tissue by stimulating cell proliferation, up-regulating tendon-specific gene expression and releasing anti-inflammatory cytokines and growth factors. More interestingly, intervention studies on the healing of rotator cuff tendon-to-bone injuries in rat models show increases in tendon stiffness and modulus and enhanced collagen organization, and type I collagen expression after prolonged rPMS without showing adverse effects in any mechanical or histological property. These results strongly support the hypothesis that rPMS might be effective in treating Achilles tendinopathy in humans. This intervention might reduce pain and functional limitations, reverse tendon degenerative changes and increase the impaired tendon mechanical and material properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design was chosen to be a randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Repetitive pulsed magnetic stimulation | Experimental | Device: Repetitive pulsed magnetic stimulationPatients 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). |
| Eccentric Calf Muscle Training for Achilles Tendinopathy | Active comparator | Procedure: Eccentric Calf Muscle Training for Achilles TendinopathyTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- Concomitant or previous participation in a clinical investigation within the last 3 months (wash out) prior to study inclusion
- Clinical suspicion of an Achilles tendon rupture.
- Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
- Severe foot deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive pulsed magnetic stimulationOMNITRON 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. | Device | Repetitive pulsed magnetic stimulation |
| Eccentric Calf Muscle Training for Achilles TendinopathyPatients 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. | Procedure or surgery | Eccentric Calf Muscle Training for Achilles Tendinopathy |
Primary outcome
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 12"
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.
Change of the experience of pain at exertion as assessed by the Visual Analogue Scale (VAS)
Time frame: "Week 4", "Week 12"
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).
Percentage of participants with an anticipated adverse event of special interest
Time frame: "Week 4"
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.
30 secondary outcomes
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 2"
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 4"
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 6"
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 8"
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A)
Time frame: "Week 0", "Week 24"
Change of the experience of pain at exertion with Visual Analogue Scale (VAS)
Time frame: "Week 0", "Week 2"
Change of the experience of pain at exertion with Visual Analogue Scale (VAS)
Time frame: "Week 0", "Week 4"
Change of the experience of pain at exertion with Visual Analogue Scale (VAS)
Time frame: "Week 0", "Week 6"
Change of the experience of pain at exertion with Visual Analogue Scale (VAS)
Time frame: "Week 0", "Week 8"
Change of the experience of pain at exertion with Visual Analogue Scale (VAS)
Time frame: "Week 0", "Week 24"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 0"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 2"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 4"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 6"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 8"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 12"
Patient Satisfaction: Psychometric response scale with Visual Analogue Scale (VAS).
Time frame: "Week 24"
Change of Achilles transverse thickness
Time frame: "Week 0", "Week 6"
Change of Achilles transverse thickness
Time frame: "Week 0", "Week 12"
Change of Neovascularization in the Achilles tendon
Time frame: "Week 0", "Week 4"
Change of Neovascularization in the Achilles tendon
Time frame: "Week 0", "Week 12"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
Time frame: "Week 2"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
Time frame: "Week 8"
Usability, graded on a scale from 1 to 5 (1 means low usability, 5 means high usability)
Time frame: "Week 12"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 0"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 2"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 6"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 8"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 12"
Percentage of participants with an anticipated adverse event of special interest.
Time frame: "Week 24"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive pulsed magnetic stimulation and Eccentric Calf Muscle Training for Achilles Tendinopathy in people with Achilles Tendinopathy, run by Gesundheitszentrum Woergl at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Traweger, Prof.Dr. (+43(0)69910763674, traweger@healthfactories.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the experience of pain and functionality with the Victorian Institute of Sports Assessment questionnaire (VISA-A) (time frame: "Week 0", "Week 12"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.