HealthyNCT05390359

Bioimpedance and Sensorimotor Effects of Percutaneous Electrolysis Protocols on the Patellar Tendon

A study testing High-intensity and short-duration, Low-intensity and long-duration and High-intensity, short-duration and 20 Hz in people with Healthy, run by Clinica Francisco Ortega Rehabilitacion Avanzada SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: High-intensity and short-duration, Low-intensity and long-duration and High-intensity, short-duration and 20 Hz
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteSpain
Study dates: 1 Nov 2022to 2 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy.
Between 18 and 45 years old.

Who cannot join

to suffer or to have suffered any pathology on the arm on the last 30 days.
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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Ionclinics & DEIONICS.
Valencia

Other trials in Spain

About this study

Official title: Characterization of the Effects on Bioimpedance and the Sensorimotor System After the Application of Percutaneous Electrolysis Protocols on the Patellar Tendon.

Percutaneous electrolysis is a physical therapy technique, whose main objective is the treatment of the signs and symptoms associated with tendinopathies by applying a galvanic current through a blunt dry needle. Despite its clinical use being already stablished, the physiological mechanisms underlying this therapy are still unknown and thus, the optimal parameterization. The present study proposes to perform different stimulation protocols of percutaneous electrolysis on healthy subjects patellar tendon to answer those questions.

Read the detailed description

Intervention will be performed in the middle of the patellar tendon, using ultrasonography to guide the needle insertion, without risk of affecting any adjacent structure. The theoretical basis of the technique is to produce specific controlled changes in the intervened tissue, and the pathological symptoms, through the accumulation of an electric charge. For this reason, the protocols will be the following:

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.
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.
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.
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: Healthy
Being tested: High-intensity and short-duration, Low-intensity and long-duration, High-intensity, short-duration and 20 Hz, Sham electrolysis
Keywords: Percutaneous electrolysis, Patellar tendon, Bioimpedance, Sensorimotor system, Percutaneous electrical stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High-intensity and short-durationOther
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-durationOther
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 HzOther
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 electrolysisOther
The control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.

Study groups in NCT05390359
Study group	Role	What they receive
High-intensity and short-duration	Experimental	The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle. Receives: Other: High-intensity and short-duration
Low-intensity and long-duration	Experimental	The technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle. Receives: Other: Low-intensity and long-duration
High-intensity, short-duration and 20 Hz	Experimental	The technique consists of the percutaneous electrical stimulation of the tendon applying a alternating current through a ultrasound-guided needle. Receives: Other: High-intensity, short-duration and 20 Hz
Sham electrolysis	Sham comparator	The technique consists of an introduction ultrasound-guided needle without electrical stimulation. Receives: Other: Sham electrolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in pain evoked with Von Frey Filaments.
We will use Von Frey Filaments to apply a 300g pressure in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The subject will report the pain intensity verbally administered Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain). The test will be performed with subject's eyes closed.
Measured: Pre-intervention and immediately after the intervention

Secondary outcomes (14)

Change in transcutaneous electrical detection threshold.
We will use a transcutaneous active electrode to evaluate electrical detection threshold on the medial region of the tibia. We will apply an alternating current with a frequency of 2 Hz, a pulse duration of 150 msec and the intensity will be increased progressively. When the subjects perceives the electrical current, the evaluator will record the current intensity as the electrical detection threshold.
Measured: Pre-intervention and immediately after the intervention
Change in percutaneous electrical detection threshold.
We will use the intervention needle as an active electrode to evaluate electrical detection threshold on the patellar tendon. The parameters of the electric current will be 2 Hz and 150 msec of pulse duration and the intensity will be increased progressively. When the subjects perceives the electrical current, the evaluator will record the current intensity as the electrical detection threshold.
Measured: Pre-intervention and immediately after the intervention
Change in pain evoked with a transcutaneous electrical stimulus.
We will use a transcutaneous active electrode to evaluate pain evoked with electrical stimulus on the medial side of the tibia. The parameters of electric current will be 2 hz and 150 msec of pulse duration and the intensity will be x3-4 respect to the electrical detection threshold determined using an electrical transcutaneous stimulus. The subject will report the pain intensity with a verbally administered numeric rate scale (NRS): 0 will be no pain and 10 will be the maximal perception of pain.
Measured: Pre-intervention and immediately after the intervention
Change in pain evoked with a percutaneous electrical stimulus.
We will use the intervention needle as an active electrode to evaluate electrical detection threshold on the patellar tendon. The parameters of electric current will be 2 Hz and 150 msec of pulse duration and the intensity will be x4-6 respect to the electrical detection threshold determined using an electrical percutaneous simulus. The subject will report the pain intensity with a verbally administered numeric rate scale (NRS): 0 will be no pain and 10 will be the maximal perception of pain.
Measured: Pre-intervention and immediately after the intervention
Change in maximum strength during knee extension with dynamometer
The subject will be sitting with 90 degrees knee flexion and the dynamometer located at the ankle. He/she will must extend the knee executing maximal isometric force during 5 seconds, 2 times with 1 minute to rest between them.
Measured: Pre-intervention and immediately after the intervention
Change in surface electromyography signal during knee extension
The subject will be sitting with 90 degrees knee flexion and the dynamometer located at the ankle and a surface electromyography located at the muscles vastus medialis and lateralis, from the muscle quadriceps femoris. He/she will must extend the knee executing maximal isometric force during 5 seconds, 2 times with 1 minute to rest between them.
Measured: Pre-intervention and immediately after the intervention
Questionnaire Victorian Institute of Sport Assessment - Patella (VISA-P)
The subject will fulfil the visa-p questionnaire, that assess symptoms, simple test of function, and the ability to play sports, to control that the sample recruited are healthy subjects.
Measured: One week before intervention
Change in patellar tendon bioimpedance
We will use four needles in the patellar tendon as electrodes to measure bioimpedance with a specific device (ImpediMed´s SFB7). We will measure using 256 frequences ranging from 3 Kilohertz (KHz) to 1 Megahertz (MHz) in different time frames. Firstly, we will measure three times prior to the introduction of the intervention needle. Then we will measure once more after the introduction of the intervention needle. Finally, we will performed four repeated measures after the intervention (immediately, 5, 10 and 15 minutes after of the intervention).
Measured: pre-intervention / baseline, immediately after the introduction the intervention needle and immediately after the intervention
Pain induced during bioimpedance measurement.
We will continuously measure pain intensity produced by the bioimpedance recording using a digital visual analogue scale (VAS) integrated in a potentiometer: 0 will be no pain and 10 will be the maximal perception of pain.
Measured: Immediately after the intervention, immediately after the introduction the intervention needle and immediately after of the intervention.
Conditioned pain modulation
First, we will measure pressure pain threshold with an algometer on the patellar tendon. Then, we will repeat the assesment of the pressure pain threshold on the patellar tendon meanwhile we apply a moderate painful pressure on the contralateral arm (5/10 on a numeric rate scale NRS: 0 will be no pain and 10 will be the maximal perception of pain) with a pressure cuff. The change between both pressure pain threshold will assess the conditioned pain modulation. After, we will repeat the same procedure but using cutaneous electrical threshold instead of pressure.
Measured: One week before the intervention
International Physical Activity Questionnaire (IPAQ)
The subjects will answer International Physical Activity Questionnaire to assess the level of physical activity.
Measured: One week before the intervention
Questionnaire about intervention effects past 24 hours.
The subjects will answer a questionnaire about the intervention effects and the possible side effects.
Measured: 24 hours after the intervention
Pain induced during intervention
We will continuously measure pain intensity produced by the intervention using a digital visual analogue scale (VAS) integrated in a potentiometer: 0 will be no pain and 10 will be the maximal perception of pain.
Measured: During the 16 minutes of intervention
Change in threshold to elicit mechanical perception with Von Frey Filaments
We will use Von Frey Filaments of increasing caliber to apply different pressure forces in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The evaluator will score the caliber of the filament that produce a mechanical perception in the subject as the mechanical pressure threshold. The test will be performed with subject's eyes closed.
Measured: Pre-intervention and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20222 May 2023

First posted25 May 2022
Study start1 Nov 2022
Primary completion2 May 2023
Study completion2 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (43)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Crossover
Model description: Randomized intervention of repeated measures, quadruple-blinded
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05390359
Sponsor's protocol ID: EPTE/2021-BIOZ
Status last verified: May 2023
First submitted: 6 Apr 2022
Last updated: 3 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Segura León J.M., Medina i Mirapeix F., Valera Garrido F. Adverse effects of percutaneous needle electrolysis in carpal tunnel syndrome. Rev Fisioter Invasiva 2019;2:130
Valera Garrido F., Minaya Muñoz F., Ramírez Martínez P., Medina i Mirapeix F. Adverse effects associated to the application of ultrasound-guided percutaneous needle electrolysis. Rev Fisioter Invasiva 2019; 02(02): 115-116.
Valera-Garrido, Polidori F, Canet, Botet J, Ramírez F, Calvo P, et al. Clinical criteria for the application of percutaneous needle electrolysis in tendinopathies: An expert Consensus cocument and cross-sectional study among physical therapists. Revista Fisioterapia Invasiva / Journal of Invasive Techniques in Physical Therapy. 2019; 02. 055-061. 10.1055/s-0039-3402789.
Abat F, Valles SL, Gelber PE, Polidori F, Jorda A, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. An experimental study of muscular injury repair in a mouse model of notexin-induced lesion with EPI(R) technique. BMC Sports Sci Med Rehabil. 2015 Apr 17;7:7. doi: 10.1186/s13102-015-0002-0. eCollection 2015.
PubMed 25897404
Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. [Molecular repair mechanisms using the Intratissue Percutaneous Electrolysis technique in patellar tendonitis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):201-5. doi: 10.1016/j.recot.2014.01.002. Epub 2014 May 10. Spanish.
PubMed 24821478
Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
PubMed 25332934
Aparecida da Silva V, Galhardoni R, Teixeira MJ, Ciampi de Andrade D. Not just a matter of pain intensity: Effects of three different conditioning stimuli on conditioned pain modulation effects. Neurophysiol Clin. 2018 Oct;48(5):287-293. doi: 10.1016/j.neucli.2018.06.078. Epub 2018 Jun 25.
PubMed 29954673
Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
PubMed 26649058
Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
PubMed 16527396
Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.
PubMed 23801002
Rees JD, Maffulli N, Cook J. Management of tendinopathy. Am J Sports Med. 2009 Sep;37(9):1855-67. doi: 10.1177/0363546508324283. Epub 2009 Feb 2.
PubMed 19188560
Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8.
PubMed 31431267
Cannell LJ, Taunton JE, Clement DB, Smith C, Khan KM. A randomised clinical trial of the efficacy of drop squats or leg extension/leg curl exercises to treat clinically diagnosed jumper's knee in athletes: pilot study. Br J Sports Med. 2001 Feb;35(1):60-4. doi: 10.1136/bjsm.35.1.60.
PubMed 11157465
Cook JL, Khan KM, Harcourt PR, Kiss ZS, Fehrmann MW, Griffiths L, Wark JD. Patellar tendon ultrasonography in asymptomatic active athletes reveals hypoechoic regions: a study of 320 tendons. Victorian Institute of Sport Tendon Study Group. Clin J Sport Med. 1998 Apr;8(2):73-7. doi: 10.1097/00042752-199804000-00001.
PubMed 9641432
Cook JL, Malliaras P, De Luca J, Ptasznik R, Morris M. Vascularity and pain in the patellar tendon of adult jumping athletes: a 5 month longitudinal study. Br J Sports Med. 2005 Jul;39(7):458-61; discussion 458-61. doi: 10.1136/bjsm.2004.014530.
PubMed 15976171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of the Effects on Bioimpedance and the Sensorimotor System After the Application of Percutaneous Electrolysis Protocols on the Patellar Tendon.
ClinicalTrials.gov ID: NCT05390359
Acronym / sponsor ID: EPTE/2021-BIOZ
Conditions: Healthy
Keywords: Percutaneous electrolysis, Patellar tendon, Bioimpedance, Sensorimotor system, Percutaneous electrical stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Clinica Francisco Ortega Rehabilitacion Avanzada SLUniversity, hospital or other
Collaborators: Ionclinics & Deionic SL
Study start: 1 Nov 2022 (actual)
Primary completion: 2 May 2023 (actual)
Study completion: 2 May 2023 (actual)
First posted: 25 May 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.

Detailed description

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.
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.
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.
Sham electrolysis group will got the same intervention, but without applying electrical current.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Randomized intervention of repeated measures, quadruple-blinded

Arm	Type	Receives
High-intensity and short-duration	Experimental	Other: High-intensity and short-durationThe technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.
Low-intensity and long-duration	Experimental	Other: Low-intensity and long-durationThe technique consists of the percutaneous electrical stimulation of the tendon applying a galvanic current through a ultrasound-guided needle.
High-intensity, short-duration and 20 Hz	Experimental	Other: High-intensity, short-duration and 20 HzThe technique consists of the percutaneous electrical stimulation of the tendon applying a alternating current through a ultrasound-guided needle.
Sham electrolysis	Sham comparator	Other: Sham electrolysisThe technique consists of an introduction ultrasound-guided needle without electrical stimulation.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy.
Between 18 and 45 years old.

Key exclusion criteria (11 listed)

to suffer or to have suffered any pathology on the arm on the last 30 days.
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.

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
High-intensity and short-durationThe 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.	Other	High-intensity and short-duration
Low-intensity and long-durationThe 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.	Other	Low-intensity and long-duration
High-intensity, short-duration and 20 HzThe 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.	Other	High-intensity, short-duration and 20 Hz
Sham electrolysisThe control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.	Other	Sham electrolysis

Primary outcome

Change in pain evoked with Von Frey Filaments.
Time frame: Pre-intervention and immediately after the intervention
We will use Von Frey Filaments to apply a 300g pressure in the evaluated areas (tibialis anterior muscle, inferior pole of the patella and patellar tendon). The subject will report the pain intensity verbally administered Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain). The test will be performed with subject's eyes closed.

14 secondary outcomes

Change in transcutaneous electrical detection threshold.
Time frame: Pre-intervention and immediately after the intervention
Change in percutaneous electrical detection threshold.
Time frame: Pre-intervention and immediately after the intervention
Change in pain evoked with a transcutaneous electrical stimulus.
Time frame: Pre-intervention and immediately after the intervention
Change in pain evoked with a percutaneous electrical stimulus.
Time frame: Pre-intervention and immediately after the intervention
Change in maximum strength during knee extension with dynamometer
Time frame: Pre-intervention and immediately after the intervention
Change in surface electromyography signal during knee extension
Time frame: Pre-intervention and immediately after the intervention
Questionnaire Victorian Institute of Sport Assessment - Patella (VISA-P)
Time frame: One week before intervention
Change in patellar tendon bioimpedance
Time frame: pre-intervention / baseline, immediately after the introduction the intervention needle and immediately after the intervention
Pain induced during bioimpedance measurement.
Time frame: Immediately after the intervention, immediately after the introduction the intervention needle and immediately after of the intervention.
Conditioned pain modulation
Time frame: One week before the intervention
International Physical Activity Questionnaire (IPAQ)
Time frame: One week before the intervention
Questionnaire about intervention effects past 24 hours.
Time frame: 24 hours after the intervention
Pain induced during intervention
Time frame: During the 16 minutes of intervention
Change in threshold to elicit mechanical perception with Von Frey Filaments
Time frame: Pre-intervention and immediately after the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
BackgroundSegura León J.M., Medina i Mirapeix F., Valera Garrido F. Adverse effects of percutaneous needle electrolysis in carpal tunnel syndrome. Rev Fisioter Invasiva 2019;2:130
BackgroundValera Garrido F., Minaya Muñoz F., Ramírez Martínez P., Medina i Mirapeix F. Adverse effects associated to the application of ultrasound-guided percutaneous needle electrolysis. Rev Fisioter Invasiva 2019; 02(02): 115-116.
BackgroundValera-Garrido, Polidori F, Canet, Botet J, Ramírez F, Calvo P, et al. Clinical criteria for the application of percutaneous needle electrolysis in tendinopathies: An expert Consensus cocument and cross-sectional study among physical therapists. Revista Fisioterapia Invasiva / Journal of Invasive Techniques in Physical Therapy. 2019; 02. 055-061. 10.1055/s-0039-3402789.
Results publication: PubMed 25897404Abat F, Valles SL, Gelber PE, Polidori F, Jorda A, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. An experimental study of muscular injury repair in a mouse model of notexin-induced lesion with EPI(R) technique. BMC Sports Sci Med Rehabil. 2015 Apr 17;7:7. doi: 10.1186/s13102-015-0002-0. eCollection 2015.
Results publication: PubMed 24821478Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. [Molecular repair mechanisms using the Intratissue Percutaneous Electrolysis technique in patellar tendonitis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):201-5. doi: 10.1016/j.recot.2014.01.002. Epub 2014 May 10. Spanish.
Results publication: PubMed 25332934Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
Results publication: PubMed 29954673Aparecida da Silva V, Galhardoni R, Teixeira MJ, Ciampi de Andrade D. Not just a matter of pain intensity: Effects of three different conditioning stimuli on conditioned pain modulation effects. Neurophysiol Clin. 2018 Oct;48(5):287-293. doi: 10.1016/j.neucli.2018.06.078. Epub 2018 Jun 25.
Results publication: PubMed 26649058Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
Results publication: PubMed 16527396Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
Results publication: PubMed 23801002Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.
Results publication: PubMed 19188560Rees JD, Maffulli N, Cook J. Management of tendinopathy. Am J Sports Med. 2009 Sep;37(9):1855-67. doi: 10.1177/0363546508324283. Epub 2009 Feb 2.
Results publication: PubMed 31431267Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 11 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: finished, as of the sponsor's last update on 3 May 2023. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain evoked with Von Frey Filaments. (time frame: Pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390359, which also lists 43 linked publications.

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 3 May 2023.