An interventional study of low intensity percutaneous musculoskeletal electrolysis and Sham application in Achilles Tendinopathy, sponsored by Maimonides University. Recruiting at 1 site in Argentina. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Maimonides University · Not applicable, Interventional, and Treatment
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.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 102 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Maimonides University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
Device: low intensity percutaneous musculoskeletal electrolysis · Other: Silbernagel protocol
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
Device: Sham application · Other: Silbernagel protocol
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.
Also known as: percutaneous microelectrolysis
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.
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.
Also known as: Silbernagel et al. Achilles tendinopathy protocol
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: fifty-two week at study entry
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: fifty-two week at study entry
Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 41 months is above that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Maimonides University