Clinical trial NCT05390359: Bioimpedance and Sensorimotor Effects of Percutaneous Electrolysis Protocols on the Patellar Tendon
Official title: Characterization of the Effects on Bioimpedance and the Sensorimotor System After the Application of Percutaneous Electrolysis Protocols on the Patellar Tendon.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Percutaneous electrolysis
Patellar tendon
Bioimpedance
Sensorimotor system
Percutaneous electrical stimulation
Lead sponsor: Clinica Francisco Ortega Rehabilitacion Avanzada SL
Sponsor class: OTHER
Collaborators: name: Ionclinics & DEIONICS.
First posted: 2022-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized intervention of repeated measures, quadruple-blinded
Primary purpose: TREATMENT

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.

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:

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.

Eligibility criteria: Inclusion Criteria:

* Healthy.
* Between 18 and 45 years old.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in pain evoked with Von Frey Filaments.
timeFrame: Pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Change in transcutaneous electrical detection threshold.
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in percutaneous electrical detection threshold.
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in pain evoked with a transcutaneous electrical stimulus.
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in pain evoked with a percutaneous electrical stimulus.
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in maximum strength during knee extension with dynamometer
timeFrame: Pre-intervention and immediately after the intervention
measure: Change in surface electromyography signal during knee extension
timeFrame: Pre-intervention and immediately after the intervention
measure: Questionnaire Victorian Institute of Sport Assessment - Patella (VISA-P)
timeFrame: One week before intervention
measure: Change in patellar tendon bioimpedance
timeFrame: pre-intervention / baseline, immediately after the introduction the intervention needle and immediately after the intervention
measure: Pain induced during bioimpedance measurement.
timeFrame: Immediately after the intervention, immediately after the introduction the intervention needle and immediately after of the intervention.
measure: Conditioned pain modulation
timeFrame: One week before the intervention
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: One week before the intervention
measure: Questionnaire about intervention effects past 24 hours.
timeFrame: 24 hours after the intervention
measure: Pain induced during intervention
timeFrame: During the 16 minutes of intervention
measure: Change in threshold to elicit mechanical perception with Von Frey Filaments
timeFrame: Pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ionclinics & DEIONICS.
Study officials:
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Eckenrode BJ, Kietrys DM, Stackhouse SK. PAIN SENSITIVITY IN CHRONIC ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Dec;14(6):945-956.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. doi: 10.1016/s0004-9514(07)70032-6. No abstract available.