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

NCT05390359 | Completed

• 1 other identifier: EPTE/2021-BIOZ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Percutaneous electrolysis; Patellar tendon; Bioimpedance; Sensorimotor system; Percutaneous electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-intervention and immediately after the intervention

Secondary Outcomes (14)

• Change in transcutaneous electrical detection threshold.

  Pre-intervention and immediately after the intervention

• Change in percutaneous electrical detection threshold.

  Pre-intervention and immediately after the intervention

• Change in pain evoked with a transcutaneous electrical stimulus.

  Pre-intervention and immediately after the intervention

• Change in pain evoked with a percutaneous electrical stimulus.

  Pre-intervention and immediately after the intervention

• Change in maximum strength during knee extension with dynamometer

  Pre-intervention and immediately after the intervention

Study Arms (4)

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.

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.

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.

Other: High-intensity, short-duration and 20 Hz

Sham electrolysis

SHAM COMPARATOR

The technique consists of an introduction ultrasound-guided needle without electrical stimulation.

Other: Sham electrolysis

Interventions

High-intensity and short-duration OTHER

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.

High-intensity and short-duration

Low-intensity and long-duration OTHER

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.

Low-intensity and long-duration

High-intensity, short-duration and 20 Hz OTHER

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.

High-intensity, short-duration and 20 Hz

Sham electrolysis OTHER

The control ultrasound guided percutaneous electrolysis will be applied in the middle of the patellar tendon, without electrical stimulation during 366 seconds.

Sham electrolysis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy.
• Between 18 and 45 years old.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Clinica Francisco Ortega Rehabilitacion Avanzada SL: lead
• Ionclinics & DEIONICS.: collaborator

Study Sites (1)

Ionclinics & DEIONICS.

Valencia, Spain

Location

Related Publications (43)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25897404 RESULT

• 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.

  PMID: 24821478 RESULT

• 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.

  PMID: 25332934 RESULT

• 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.

  PMID: 29954673 RESULT

• 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.

  PMID: 26649058 RESULT

• 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.

  PMID: 16527396 RESULT

• 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.

  PMID: 23801002 RESULT

• 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.

  PMID: 19188560 RESULT

• 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.

  PMID: 31431267 RESULT

• 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.

  PMID: 11157465 RESULT

• 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.

  PMID: 9641432 RESULT

• 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.

  PMID: 15976171 RESULT

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 RESULT

• de la Cruz Torres B, Albornoz Cabello M, Garcia Bermejo P, Naranjo Orellana J. Autonomic responses to ultrasound-guided percutaneous needle electrolysis of the patellar tendon in healthy male footballers. Acupunct Med. 2016 Aug;34(4):275-9. doi: 10.1136/acupmed-2015-010993. Epub 2016 Jan 20.

  PMID: 26792776 RESULT

• Docking SI, Ooi CC, Connell D. Tendinopathy: Is Imaging Telling Us the Entire Story? J Orthop Sports Phys Ther. 2015 Nov;45(11):842-52. doi: 10.2519/jospt.2015.5880. Epub 2015 Sep 21.

  PMID: 26390270 RESULT

• Eckenrode BJ, Kietrys DM, Stackhouse SK. PAIN SENSITIVITY IN CHRONIC ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Dec;14(6):945-956.

  PMID: 31803527 RESULT

• Fernandez-Rodriguez T, Fernandez-Rolle A, Truyols-Dominguez S, Benitez-Martinez JC, Casana-Granell J. Prospective Randomized Trial of Electrolysis for Chronic Plantar Heel Pain. Foot Ankle Int. 2018 Sep;39(9):1039-1046. doi: 10.1177/1071100718773998. Epub 2018 May 17.

  PMID: 29771148 RESULT

• Figueroa D, Figueroa F, Calvo R. Patellar Tendinopathy: Diagnosis and Treatment. J Am Acad Orthop Surg. 2016 Dec;24(12):e184-e192. doi: 10.5435/JAAOS-D-15-00703.

  PMID: 27855131 RESULT

• Fruhstorfer H, Gross W, Selbmann O. von Frey hairs: new materials for a new design. Eur J Pain. 2001;5(3):341-2. doi: 10.1053/eujp.2001.0250.

  PMID: 11558991 RESULT

• Goldin M, Malanga GA. Tendinopathy: a review of the pathophysiology and evidence for treatment. Phys Sportsmed. 2013 Sep;41(3):36-49. doi: 10.3810/psm.2013.09.2019.

  PMID: 24113701 RESULT

• Golman M, Wright ML, Wong TT, Lynch TS, Ahmad CS, Thomopoulos S, Popkin CA. Rethinking Patellar Tendinopathy and Partial Patellar Tendon Tears: A Novel Classification System. Am J Sports Med. 2020 Feb;48(2):359-369. doi: 10.1177/0363546519894333. Epub 2020 Jan 8.

  PMID: 31913662 RESULT

• Hernandez-Sanchez S, Hidalgo MD, Gomez A. Cross-cultural adaptation of VISA-P score for patellar tendinopathy in Spanish population. J Orthop Sports Phys Ther. 2011 Aug;41(8):581-91. doi: 10.2519/jospt.2011.3613. Epub 2011 Jul 12.

  PMID: 21765223 RESULT

• Hutchison MK, Houck J, Cuddeford T, Dorociak R, Brumitt J. Prevalence of Patellar Tendinopathy and Patellar Tendon Abnormality in Male Collegiate Basketball Players: A Cross-Sectional Study. J Athl Train. 2019 Sep;54(9):953-958. doi: 10.4085/1062-6050-70-18. Epub 2019 Aug 19.

  PMID: 31424974 RESULT

• Jaffrin MY, Morel H. Body fluid volumes measurements by impedance: A review of bioimpedance spectroscopy (BIS) and bioimpedance analysis (BIA) methods. Med Eng Phys. 2008 Dec;30(10):1257-69. doi: 10.1016/j.medengphy.2008.06.009. Epub 2008 Aug 3.

  PMID: 18676172 RESULT

• Kregel J, van Wilgen CP, Zwerver J. Pain assessment in patellar tendinopathy using pain pressure threshold algometry: an observational study. Pain Med. 2013 Nov;14(11):1769-75. doi: 10.1111/pme.12178. Epub 2013 Jun 26.

  PMID: 23802873 RESULT

• Lopez-Royo MP, Gomez-Trullen EM, Ortiz-Lucas M, Galan-Diaz RM, Bataller-Cervero AV, Al-Boloushi Z, Hamam-Alcober Y, Herrero P. Comparative study of treatment interventions for patellar tendinopathy: a protocol for a randomised controlled trial. BMJ Open. 2020 Feb 16;10(2):e034304. doi: 10.1136/bmjopen-2019-034304.

  PMID: 32066608 RESULT

• Maffiuletti NA, Aagaard P, Blazevich AJ, Folland J, Tillin N, Duchateau J. Rate of force development: physiological and methodological considerations. Eur J Appl Physiol. 2016 Jun;116(6):1091-116. doi: 10.1007/s00421-016-3346-6. Epub 2016 Mar 3.

  PMID: 26941023 RESULT

• Martin-Pintado-Zugasti A, Rodriguez-Fernandez AL, Fernandez-Carnero J. Postneedling soreness after deep dry needling of a latent myofascial trigger point in the upper trapezius muscle: Characteristics, sex differences and associated factors. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):301-308. doi: 10.3233/BMR-150630.

  PMID: 26406209 RESULT

• Moreno C, Mattiussi G, Nunez FJ, Messina G, Rejc E. Intratissue percutaneous electolysis combined with active physical therapy for the treatment of adductor longus enthesopathy-related groin pain: a randomized trial. J Sports Med Phys Fitness. 2017 Oct;57(10):1318-1329. doi: 10.23736/S0022-4707.16.06466-5. Epub 2017 Jan 23.

  PMID: 28116876 RESULT

• Muhsen A, Moss P, Gibson W, Walker B, Jacques A, Schug S, Wright A. The Association Between Conditioned Pain Modulation and Manipulation-induced Analgesia in People With Lateral Epicondylalgia. Clin J Pain. 2019 May;35(5):435-442. doi: 10.1097/AJP.0000000000000696.

  PMID: 30801339 RESULT

• Rio E, Moseley L, Purdam C, Samiric T, Kidgell D, Pearce AJ, Jaberzadeh S, Cook J. The pain of tendinopathy: physiological or pathophysiological? Sports Med. 2014 Jan;44(1):9-23. doi: 10.1007/s40279-013-0096-z.

  PMID: 24027089 RESULT

• Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.

  PMID: 32545583 RESULT

• Rodriguez-Huguet M, Gongora-Rodriguez J, Lomas-Vega R, Martin-Valero R, Diaz-Fernandez A, Obrero-Gaitan E, Ibanez-Vera AJ, Rodriguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7):2068. doi: 10.3390/jcm9072068.

  PMID: 32630241 RESULT

• Sdrulla AD, Xu Q, He SQ, Tiwari V, Yang F, Zhang C, Shu B, Shechter R, Raja SN, Wang Y, Dong X, Guan Y. Electrical stimulation of low-threshold afferent fibers induces a prolonged synaptic depression in lamina II dorsal horn neurons to high-threshold afferent inputs in mice. Pain. 2015 Jun;156(6):1008-1017. doi: 10.1097/01.j.pain.0000460353.15460.a3.

  PMID: 25974163 RESULT

• Shiose K, Tanabe Y, Ohnishi T, Takahashi H. Effect of regional muscle damage and inflammation following eccentric exercise on electrical resistance and the body composition assessment using bioimpedance spectroscopy. J Physiol Sci. 2019 Nov;69(6):895-901. doi: 10.1007/s12576-019-00702-8. Epub 2019 Aug 6.

  PMID: 31388975 RESULT

• Smidt N, van der Windt DA, Assendelft WJ, Mourits AJ, Deville WL, de Winter AF, Bouter LM. Interobserver reproducibility of the assessment of severity of complaints, grip strength, and pressure pain threshold in patients with lateral epicondylitis. Arch Phys Med Rehabil. 2002 Aug;83(8):1145-50. doi: 10.1053/apmr.2002.33728.

  PMID: 12161838 RESULT

• Stoychev V, Finestone AS, Kalichman L. Dry Needling as a Treatment Modality for Tendinopathy: a Narrative Review. Curr Rev Musculoskelet Med. 2020 Feb;13(1):133-140. doi: 10.1007/s12178-020-09608-0.

  PMID: 31942676 RESULT

• Scott A, Squier K, Alfredson H, Bahr R, Cook JL, Coombes B, de Vos RJ, Fu SN, Grimaldi A, Lewis JS, Maffulli N, Magnusson SP, Malliaras P, Mc Auliffe S, Oei EHG, Purdam CR, Rees JD, Rio EK, Gravare Silbernagel K, Speed C, Weir A, Wolf JM, Akker-Scheek IVD, Vicenzino BT, Zwerver J. ICON 2019: International Scientific Tendinopathy Symposium Consensus: Clinical Terminology. Br J Sports Med. 2020 Mar;54(5):260-262. doi: 10.1136/bjsports-2019-100885. Epub 2019 Aug 9. No abstract available.

  PMID: 31399426 RESULT

• Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

  PMID: 25122629 RESULT

• Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. doi: 10.1016/s0004-9514(07)70032-6. No abstract available.

  PMID: 17899675 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The order of the interventions will be randomized by a third person not involved in the treatment, assessment or statistical analysis. Once the care provider has inserted the needle in each subject, the investigator that apply the treatment will choose the treatment protocol assigned on the stimulator, previously programmed and codified. Thus, nobody (participant, care provider, investigator and the outcome assessor) will know what intervention is applied.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized intervention of repeated measures, quadruple-blinded

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 25, 2022
• Study Start: November 1, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)