Bioimpedance and Sensorimotor Effects of Percutaneous Electrolysis Protocols on the Patellar Tendon
NCT ID: NCT05390359
Last Updated: 2023-05-03
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-11-01
2023-05-02
Brief Summary
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Detailed Description
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1. High-intensity and short-duration: 3 squared pulses of a high intensity galvanic current (3 mA) for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.
2. Low-intensity and long-duration: 3 squared pulses of a low intensity galvanic current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 30 seconds of pulses ramp. The total intervention time will be 366 seconds.
3. High-intensity, short-duration and 20 Hertz (Hz): 3 squared pulses of a high intensity compensated biphasic squared current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternative frequency of 20 Hz and the pulse width of 50 ms. The current will be off during the first 348 seconds of the intervention and the last 18 seconds it will be on. The total intervention time will be 366 seconds.
4. Sham electrolysis group will got the same intervention, but without applying electrical current.
The study design will be an crossover clinical trial, with randomized order of intervention with repeated measurements. Therefore, each subject will be have the four protocols at randomized order, with a gap of at least one week between them. The study will be full blinded.
The capacity to recruit the inhibitory system will be evaluated by means of conditioned pain modulation. Moreover, somatosensory thresholds will be evaluated in the knee, as well as knee extension strength. In addition, we will undertake continuous measures of the electrical bioimpedance of the patellar tendon, to study the changes produced by the intervention in the different intra and extracellular tissue components.
The conditioned modulation of pain assesment will take place one week before to the intervention, and the remaining measurements will be measured pre-intervention and post-intervention for each protocol.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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High-intensity and short-duration
The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.
High-intensity and short-duration
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 squared pulses of a high intensity current (3 mA), that will be applied for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp.
The current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.
Low-intensity and long-duration
The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.
Low-intensity and long-duration
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 squared pulses of a low intensity direct current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 1 second of pulses ramp.
The total treatment time will be 366 seconds.
High-intensity, short-duration and 20 Hz
The technique consists of the percutaneous electrical stimulation of the tendon applying a alternating current through a ultrasound-guided needle.
High-intensity, short-duration and 20 Hz
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 pulses of a high intensity compensated biphasic current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternating frequency will be of 20 Hz and the pulse width of 50 microseconds.
The current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.
Sham electrolysis
The technique consists of an introduction ultrasound-guided needle without electrical stimulation.
Sham electrolysis
The control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.
Interventions
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High-intensity and short-duration
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 squared pulses of a high intensity current (3 mA), that will be applied for 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp.
The current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.
Low-intensity and long-duration
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 squared pulses of a low intensity direct current (0.1 mA) during 90 seconds, with 3 seconds rests between pulses and 1 second of pulses ramp.
The total treatment time will be 366 seconds.
High-intensity, short-duration and 20 Hz
The ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon.
The parameters will be 3 pulses of a high intensity compensated biphasic current (3 mA), during 3 seconds with 3 seconds rests between pulses and 1 second of pulses ramp. The alternating frequency will be of 20 Hz and the pulse width of 50 microseconds.
The current will be off on the first 348 seconds of the intervention approximately and the last 18 seconds it will be on. The total treatment time will be 366 seconds.
Sham electrolysis
The control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 45 years old.
Exclusion Criteria
* to suffer some disease discouraging current application or needling, as coagulation deficit, etc.
* to suffer some severe disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.
* to suffer some cognitive disorders.
* to consume drugs as coagulants, anti-depressant, pregabalin, neuropeptide, opioids, etc during investigation or the first week before investigation.
* to consume NSAIDS the last 48 hours before investigation or during investigation.
* belonephobia.
* To consume caffeine 2 hours prior to the investigation or perform intense exercise on the same day as the measurement.
* To receive concomitant physical therapy treatments or have previously received percutaneous electrolysis treatment.
* professional athlete
* To be pregnant.
18 Years
45 Years
ALL
Yes
Sponsors
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Ionclinics & DEIONICS.
UNKNOWN
Clinica Francisco Ortega Rehabilitacion Avanzada SL
OTHER
Responsible Party
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Locations
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Ionclinics & DEIONICS.
Valencia, , Spain
Countries
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References
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Other Identifiers
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EPTE/2021-BIOZ
Identifier Type: -
Identifier Source: org_study_id
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