Achilles TendinopathyNCT05301959
Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy
A study testing low intensity percutaneous musculoskeletal electrolysis and Silbernagel protocol in people with Achilles Tendinopathy, run by Maimonides University at 1 site in Argentina.
Trial summary
Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- low intensity percutaneous musculoskeletal electrolysis and Silbernagel protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
- Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
- Evidence of tendinopathy by MRI.
- Presence of post-static dyskinesia.
- Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
- Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.
Who cannot join
- Presence or suspicion of pregnancy.
- Previous surgical intervention on the AT in the symptomatic leg(s)
- Total or partial rupture in the symptomatic AT
- Chronic ankle instability, in the foot with symptomatic tendon(s).
- Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
- Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
Show all 13Show fewer
- Psychological disorders.
- Oncologic history.
- Treatment with quinolones or fluoroquinolones during the last two years.
- Treatment with statins for the control of hypercholesterolemia for more than two months
- Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
- Needle phobia
- Allergy to metal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Maimonides University
Buenos Aires, Buenos Aires F.D., 1405
Oscar Ronzio, DHSc, +541149051140, ronzio.oscar@maimonides.edu
About this study
Official title: Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial
Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment.
Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia.
Read more
The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality.
A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
- Conditions
- Achilles Tendinopathy
- Being tested
- low intensity percutaneous musculoskeletal electrolysis, Sham application, Silbernagel protocol
- Keywords
- tendinopathy, physiotherapy, percutaneous electrolysis
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity percutaneous musculoskeletal electrolysisDevice
Also called percutaneous microelectrolysis
An acupuncture needle (0.30mm X 25mm) will be introduced into the device's strut. With the equipment on and with a base intensity of 120µA, the acupuncture needle is introduced in a proximal-distal and postero-anterior direction, in the area of the Achilles tendon body. The position of the needle will be checked with ultrasound and once the point to be treated is reached, the working intensity will be increased up to 600 µA. The emission will be maintained until the participant reports a pain of 60/100 in VAS. At that moment, the emission will be paused completely until the participant reports a sensation of at least 20/100 in VAS. After this period the emission will be continued at 600 µA. This cycle will continue until the emission lasts for more than 120 sec, continuously. At this point, the needle will be repositioned to repeat the emission protocol a maximum of 3 times in total.
Sham applicationDevice
A modification will be made in a second equipment, closing the circuit with a 10kΩ resistor inside the equipment, in the output strand chip. Allowing the simulation of emission without emitting current to the participant and without being able to appreciate any type of alteration in the handling of the equipment, by the operators. Therefore, the same steps will be followed as in the experimental group.
Silbernagel protocolOther
Also called Silbernagel et al. Achilles tendinopathy protocol
The Silbernagel et al. protocol comprises several heel raising exercises with concentric and eccentric movements, performed on two legs and one leg. It is composed of 3 sets of 15 repetitions and that during the exercises allows pain to be present, but not being disabling. The exercises will be performed only once a day. The progression will be made by changing from standing exercises to monopodal support, moving from concentric-eccentric to purely eccentric loading, adding weight in a backpack (in steps of 5 kg when pain does not exceed 5 in the pain monitoring model) and finally using fast rebound exercises and plyometric exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner. Receives: Device: low intensity percutaneous musculoskeletal electrolysis; Other: Silbernagel protocol |
| Simulated group. | Sham comparator | The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off. Receives: Device: Sham application; Other: Silbernagel protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment - Achilles - Baseline
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: Baseline
Victorian Institute of Sport Assessment - Achilles - Week 1
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: one week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 2
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: two week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 3
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: three week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 4
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: four week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 5
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: five week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 6
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: six week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 7
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: seven week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 8
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: eight week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 9
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: nine week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 10
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: ten week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 11
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: eleven week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 12
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: twelve week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 26
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: twenty-six week at study entry
Victorian Institute of Sport Assessment - Achilles - Week 52
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Measured: fifty-two week at study entry
Secondary outcomes (42)
visual analog scale - Baseline
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: Baseline
visual analog scale - Week 1
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: one week at study entry
visual analog scale - Week 2
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: Two week at study entry
visual analog scale - Week 3
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: three week at study entry
visual analog scale - Week 4
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: four week at study entry
visual analog scale - Week 5
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: five week at study entry
visual analog scale - Week 6
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: six week at study entry
visual analog scale - Week 7
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: seven week at study entry
visual analog scale - Week 8
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: eight week at study entry
visual analog scale - Week 9
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: nine week at study entry
visual analog scale - Week 10
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: ten week at study entry
visual analog scale - Week 11
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: eleven week at study entry
visual analog scale - Week 12
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: twelve week at study entry
visual analog scale - Week 26
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: twenty-six week at study entry
visual analog scale - Week 52
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Measured: fifty-two week at study entry
The Foot and Ankle Ability Measure - Baseline
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: Baseline
The Foot and Ankle Ability Measure - Week 1
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: one week at study entry
The Foot and Ankle Ability Measure - Week 2
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: two week at study entry
The Foot and Ankle Ability Measure - Week 3
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: three week at study entry
The Foot and Ankle Ability Measure - Week 4
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: four week at study entry
The Foot and Ankle Ability Measure - Week 5
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: five week at study entry
The Foot and Ankle Ability Measure - Week 6
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: six week at study entry
The Foot and Ankle Ability Measure - Week 7
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: seven week at study entry
The Foot and Ankle Ability Measure - Week 8
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: eight week at study entry
The Foot and Ankle Ability Measure - Week 9
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: nine week at study entry
The Foot and Ankle Ability Measure - Week 10
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: ten week at study entry
The Foot and Ankle Ability Measure - Week 11
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: eleven week at study entry
The Foot and Ankle Ability Measure - Week 12
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: twelve week at study entry
The Foot and Ankle Ability Measure - Week 26
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: twenty-six week at study entry
The Foot and Ankle Ability Measure - Week 52
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Measured: fifty-two week at study entry
ultrasound Shear Wave elastography - baseline
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: Baseline
ultrasound Shear Wave elastography - Week 4
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: four week at study entry
ultrasound Shear Wave elastography - Week 8
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: eight week at study entry
ultrasound Shear Wave elastography - Week 12
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: twelve week at study entry
ultrasound Shear Wave elastography - Week 26
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: twenty-six week at study entry
ultrasound Shear Wave elastography - Week 52
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Measured: fifty-two week at study entry
Vienna Achilles tendon morphological score - MRI - baseline
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: Baseline
Vienna Achilles tendon morphological score - MRI - Week 4
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: four week at study entry
Vienna Achilles tendon morphological score - MRI - Week 8
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: eight week at study entry
Vienna Achilles tendon morphological score - MRI - Week 12
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: twelve week at study entry
Vienna Achilles tendon morphological score - MRI - Week 26
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: twenty-six week at study entry
Vienna Achilles tendon morphological score - MRI - Week 52
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Measured: fifty-two week at study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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
- A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimonides University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Marcelo d'Almeida, PT SCS PhD Candidate, Maimonides University
- Investigators
- Santiago M d'Almeida, PT SCS, Principal investigator, Maimonides University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301959
- Sponsor's protocol ID
- 5694
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05301959
- Acronym / sponsor ID
- 5694
- Conditions
- Achilles Tendinopathy
- Keywords
- tendinopathy, physiotherapy, percutaneous electrolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Maimonides UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (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.
Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment.
Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia.
The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality.
A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: low intensity percutaneous musculoskeletal electrolysis, Other: Silbernagel protocolA single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner. |
| Simulated group. | Sham comparator | Device: Sham application, Other: Silbernagel protocolThe application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
- Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
- Evidence of tendinopathy by MRI.
- Presence of post-static dyskinesia.
- Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
Key exclusion criteria (13 listed)
- Presence or suspicion of pregnancy.
- Previous surgical intervention on the AT in the symptomatic leg(s)
- Total or partial rupture in the symptomatic AT
- Chronic ankle instability, in the foot with symptomatic tendon(s).
- Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
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 |
|---|---|---|
| low intensity percutaneous musculoskeletal electrolysisAlso: percutaneous microelectrolysisAn acupuncture needle (0.30mm X 25mm) will be introduced into the device's strut. With the equipment on and with a base intensity of 120µA, the acupuncture needle is introduced in a proximal-distal and postero-anterior direction, in the area of the Achilles tendon body. The position of the needle will be checked with ultrasound and once the point to be treated is reached, the working intensity will be increased up to 600 µA. The emission will be maintained until the participant reports a pain of 60/100 in VAS. At that moment, the emission will be paused completely until the participant reports a sensation of at least 20/100 in VAS. After this period the emission will be continued at 600 µA. This cycle will continue until the emission lasts for more than 120 sec, continuously. At this point, the needle will be repositioned to repeat the emission protocol a maximum of 3 times in total. | Device | Experimental group |
| Sham applicationA modification will be made in a second equipment, closing the circuit with a 10kΩ resistor inside the equipment, in the output strand chip. Allowing the simulation of emission without emitting current to the participant and without being able to appreciate any type of alteration in the handling of the equipment, by the operators. Therefore, the same steps will be followed as in the experimental group. | Device | Simulated group. |
| Silbernagel protocolAlso: Silbernagel et al. Achilles tendinopathy protocolThe Silbernagel et al. protocol comprises several heel raising exercises with concentric and eccentric movements, performed on two legs and one leg. It is composed of 3 sets of 15 repetitions and that during the exercises allows pain to be present, but not being disabling. The exercises will be performed only once a day. The progression will be made by changing from standing exercises to monopodal support, moving from concentric-eccentric to purely eccentric loading, adding weight in a backpack (in steps of 5 kg when pain does not exceed 5 in the pain monitoring model) and finally using fast rebound exercises and plyometric exercises. | Other | Experimental group, Simulated group. |
Primary outcome
Victorian Institute of Sport Assessment - Achilles - Baseline
Time frame: Baseline
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 1
Time frame: one week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 2
Time frame: two week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 3
Time frame: three week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 4
Time frame: four week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 5
Time frame: five week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 6
Time frame: six week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 7
Time frame: seven week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 8
Time frame: eight week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 9
Time frame: nine week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 10
Time frame: ten week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 11
Time frame: eleven week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 12
Time frame: twelve week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 26
Time frame: twenty-six week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 52
Time frame: fifty-two week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
42 secondary outcomes
visual analog scale - Baseline
Time frame: Baseline
visual analog scale - Week 1
Time frame: one week at study entry
visual analog scale - Week 2
Time frame: Two week at study entry
visual analog scale - Week 3
Time frame: three week at study entry
visual analog scale - Week 4
Time frame: four week at study entry
visual analog scale - Week 5
Time frame: five week at study entry
visual analog scale - Week 6
Time frame: six week at study entry
visual analog scale - Week 7
Time frame: seven week at study entry
visual analog scale - Week 8
Time frame: eight week at study entry
visual analog scale - Week 9
Time frame: nine week at study entry
visual analog scale - Week 10
Time frame: ten week at study entry
visual analog scale - Week 11
Time frame: eleven week at study entry
visual analog scale - Week 12
Time frame: twelve week at study entry
visual analog scale - Week 26
Time frame: twenty-six week at study entry
visual analog scale - Week 52
Time frame: fifty-two week at study entry
The Foot and Ankle Ability Measure - Baseline
Time frame: Baseline
The Foot and Ankle Ability Measure - Week 1
Time frame: one week at study entry
The Foot and Ankle Ability Measure - Week 2
Time frame: two week at study entry
The Foot and Ankle Ability Measure - Week 3
Time frame: three week at study entry
The Foot and Ankle Ability Measure - Week 4
Time frame: four week at study entry
The Foot and Ankle Ability Measure - Week 5
Time frame: five week at study entry
The Foot and Ankle Ability Measure - Week 6
Time frame: six week at study entry
The Foot and Ankle Ability Measure - Week 7
Time frame: seven week at study entry
The Foot and Ankle Ability Measure - Week 8
Time frame: eight week at study entry
The Foot and Ankle Ability Measure - Week 9
Time frame: nine week at study entry
The Foot and Ankle Ability Measure - Week 10
Time frame: ten week at study entry
The Foot and Ankle Ability Measure - Week 11
Time frame: eleven week at study entry
The Foot and Ankle Ability Measure - Week 12
Time frame: twelve week at study entry
The Foot and Ankle Ability Measure - Week 26
Time frame: twenty-six week at study entry
The Foot and Ankle Ability Measure - Week 52
Time frame: fifty-two week at study entry
ultrasound Shear Wave elastography - baseline
Time frame: Baseline
ultrasound Shear Wave elastography - Week 4
Time frame: four week at study entry
ultrasound Shear Wave elastography - Week 8
Time frame: eight week at study entry
ultrasound Shear Wave elastography - Week 12
Time frame: twelve week at study entry
ultrasound Shear Wave elastography - Week 26
Time frame: twenty-six week at study entry
ultrasound Shear Wave elastography - Week 52
Time frame: fifty-two week at study entry
Vienna Achilles tendon morphological score - MRI - baseline
Time frame: Baseline
Vienna Achilles tendon morphological score - MRI - Week 4
Time frame: four week at study entry
Vienna Achilles tendon morphological score - MRI - Week 8
Time frame: eight week at study entry
Vienna Achilles tendon morphological score - MRI - Week 12
Time frame: twelve week at study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Related trials for Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
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.
Santiago M d'Almeida, PT SCS principal investigator
Maimonides University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity percutaneous musculoskeletal electrolysis and Silbernagel protocol in people with Achilles Tendinopathy, run by Maimonides University at 1 site in Argentina.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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 Argentina. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santiago M d'Almeida, PT SCS (01140573099, dalmeida.santiago@maimonides.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment - Achilles - Baseline (time frame: Baseline). The study lists 15 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 29 Apr 2026.