Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System in Healthy Subjects

Healthy Clinical Trial

Official title:

Effects of Percutaneous Neuromodulation on Plasticity in the Somatosensory System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475133
• Other study ID #: NMP19/20-FREMPI
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: October 29, 2020

Study information

• Verified date: January 2022
• Source: Clinica Francisco Ortega Rehabilitacion Avanzada SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Echography guided percutaneous neuromodulation is a physical therapy technique, whose main objective is the treatment of pain with direct stimulation of the peripheral nerves using a rome needle of acupuncture as an active electrode for applying currents of electrostimulation.

The neurophysiological basis and the effects on the sensory and motor systems of this technique are not characterised. The present study proposes to perform the intervention on the area adjacent to the median nerve and to apply different stimulation protocols on healthy subjects to answer those questions.

Description:

Intervention is going to be performed in the medial side of the arm, where the median nerve is accessible to the intervention. The theoretical basis of the technique is to produce specific controlled changes in the somatosensory system using synaptic plasticity, to ultimate affect the perception of pain through reduction of nociception afference. Subsequently, the protocols are based on synaptic physiology and the circuitry of the somatosensory system.

The protocols are the following:

1. - low-frequency and high-intensity of stimulation: 2hz during 16 min at an slightly annoying intensity, to induce synaptic depression on the c-fibers circuit, presumably carrying nociception.

2. - high-frequency and low-intensity of stimulation: 100 hz in 5 second trains, separated by 1 min of no current with a perceptible but mild intensity, to induce potentiation of a-beta fibers, presumably englobing mechanoreceptors which inhibit nociception through gate control in the spinal cord.

3. - placebo group has got the same intervention, but without current.

The study design is an experimental clinical trial, with randomized order of intervention with repeated measurements. This means each subject is having the three protocols at randomized order, with a gap of at least two weeks between them. The study is triple-blinded.

Somatomotor system variables, as sensory and pain pressure thresholds, grip strength, surface electromyographic activity and blood flow are evaluated on the hand of the subject. The arm to treat was also randomized for each subject The measurements are pre-intervention, post-intervention and 24 hours after the intervention for each protocol. Blood flow are measured only pre-intervention and post-intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria:

• healthy.

• more than 18 years old

• amateur athlete.

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 needle¡ing, as coagulation deficit, etc.

• to suffer some disease as diabetes mellitus, cancer, neurology disease, depression, fibromyalgia, etc.

• to consume drugs as coagulants, anti-depressant, pregabalin, etc during investigation or the first week before investigation.

• to consume nsaids the last 48 hours before investigation or during investigation.

• to consume opioids the first week before investigation or during investigation.

• belonephobia.

• professional athlete

• to be pregnant

• to suffer immunodepression

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Ultrasound guided percutaneous neuromodulation
It is a technique that consists in the electrical stimulation of peripheral nerve trunks, inserting an acupuncture needle in its path and using it as an electrode to apply electrical current

Locations

Country	Name	City	State
Spain	Clínica Francisco Ortega Rehabilitación Avanzada, S.L.	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Francisco Ortega Rehabilitacion Avanzada SL

Country where clinical trial is conducted

Spain, 

References & Publications (50)

Amer-Cuenca, J. J. (2010). Programacio´n y aplicacio´n de la estimulacio´n nerviosa ele´ctrica transcuta´nea (TENS): gui´a de pra´ctica cli´nica basada en la evidencia. Fisioterapia, 32(6), 271-278.

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. Epub 2006 Mar 9. — View Citation

Bliss TV, Collingridge GL. A synaptic model of memory: long-term potentiation in the hippocampus. Nature. 1993 Jan 7;361(6407):31-9. Review. — View Citation

Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. — View Citation

Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. Review. — View Citation

Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Ma — View Citation

Chan AW, MacFarlane IA, Bowsher D, Campbell JA. Weighted needle pinprick sensory thresholds: a simple test of sensory function in diabetic peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1992 Jan;55(1):56-9. — View Citation

Chapman CR, Gavrin J. Suffering: the contributions of persistent pain. Lancet. 1999 Jun 26;353(9171):2233-7. Review. — View Citation

Corneil BD, Goonetilleke SC, Peel TR, Green KA, Welch ID. Ultrasound-guided insertion of intramuscular electrodes into suboccipital muscles in the non-human primate. J Electromyogr Kinesiol. 2012 Aug;22(4):553-9. doi: 10.1016/j.jelekin.2012.02.014. Epub 2 — View Citation

Domingo A, Mayoral O, Monterde S, Santafé MM. Neuromuscular damage and repair after dry needling in mice. Evid Based Complement Alternat Med. 2013;2013:260806. doi: 10.1155/2013/260806. Epub 2013 Apr 9. — View Citation

Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065. — View Citation

Dubuisson D. Effect of dorsal-column stimulation on gelatinosa and marginal neurons of cat spinal cord. J Neurosurg. 1989 Feb;70(2):257-65. — View Citation

Falowski S, Celii A, Sharan A. Spinal cord stimulation: an update. Neurotherapeutics. 2008 Jan;5(1):86-99. doi: 10.1016/j.nurt.2007.10.066. Review. — View Citation

Finnerup NB, Sindrup SH, Jensen TS. Recent advances in pharmacological treatment of neuropathic pain. F1000 Med Rep. 2010 Jul 14;2:52. doi: 10.3410/M2-52. — View Citation

Foreman RD, Linderoth B. Neural mechanisms of spinal cord stimulation. Int Rev Neurobiol. 2012;107:87-119. doi: 10.1016/B978-0-12-404706-8.00006-1. Review. — View Citation

Fruhstorfer H, Gross W, Selbmann O. von Frey hairs: new materials for a new design. Eur J Pain. 2001;5(3):341-2. — View Citation

Heinricher MM, Tavares I, Leith JL, Lumb BM. Descending control of nociception: Specificity, recruitment and plasticity. Brain Res Rev. 2009 Apr;60(1):214-25. doi: 10.1016/j.brainresrev.2008.12.009. Epub 2008 Dec 25. Review. — View Citation

Kalra A, Urban MO, Sluka KA. Blockade of opioid receptors in rostral ventral medulla prevents antihyperalgesia produced by transcutaneous electrical nerve stimulation (TENS). J Pharmacol Exp Ther. 2001 Jul;298(1):257-63. — View Citation

Kendall NA. Psychosocial approaches to the prevention of chronic pain: the low back paradigm. Baillieres Best Pract Res Clin Rheumatol. 1999 Sep;13(3):545-54. Review. — View Citation

Klein T, Magerl W, Hopf HC, Sandkühler J, Treede RD. Perceptual correlates of nociceptive long-term potentiation and long-term depression in humans. J Neurosci. 2004 Jan 28;24(4):964-71. — View 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. — View Citation

MENDELL LM, WALL PD. RESPONSES OF SINGLE DORSAL CORD CELLS TO PERIPHERAL CUTANEOUS UNMYELINATED FIBRES. Nature. 1965 Apr 3;206:97-9. — View Citation

Ng DT, Spear ED, Walter P. The unfolded protein response regulates multiple aspects of secretory and membrane protein biogenesis and endoplasmic reticulum quality control. J Cell Biol. 2000 Jul 10;150(1):77-88. — View Citation

Ochoa JL. Pain mechanisms in neuropathy. Curr Opin Neurol. 1994 Oct;7(5):407-14. Review. — View Citation

Randic M, Jiang MC, Cerne R. Long-term potentiation and long-term depression of primary afferent neurotransmission in the rat spinal cord. J Neurosci. 1993 Dec;13(12):5228-41. — View Citation

RaviChandran N, Aw KC, McDaid A. Characterizing the Motor Points of Forearm Muscles for Dexterous Neuroprostheses. IEEE Trans Biomed Eng. 2020 Jan;67(1):50-59. doi: 10.1109/TBME.2019.2907926. Epub 2019 Mar 28. — View Citation

Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. — View Citation

Russo CM, Brose WG. Chronic pain. Annu Rev Med. 1998;49:123-33. Review. — View Citation

Sandkühler J, Liu X. Induction of long-term potentiation at spinal synapses by noxious stimulation or nerve injury. Eur J Neurosci. 1998 Jul;10(7):2476-80. — View Citation

Sandkühler J. Learning and memory in pain pathways. Pain. 2000 Nov;88(2):113-118. doi: 10.1016/S0304-3959(00)00424-3. Review. — View Citation

Schaible HG. Peripheral and central mechanisms of pain generation. Handb Exp Pharmacol. 2007;(177):3-28. — View 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 affe — View Citation

Shacklock M. (2007). Neurodina´mica cli´nica: un nuevo sistema de tratamiento musculoesquele´tico. Madrid: Elsevier.

Shay BL, Hochman S. Serotonin alters multi-segmental convergence patterns in spinal cord deep dorsal horn and intermediate laminae neurons in an in vitro young rat preparation. Pain. 2002 Jan;95(1-2):7-14. — View Citation

Sivilotti LG, Thompson SW, Woolf CJ. Rate of rise of the cumulative depolarization evoked by repetitive stimulation of small-caliber afferents is a predictor of action potential windup in rat spinal neurons in vitro. J Neurophysiol. 1993 May;69(5):1621-31 — View Citation

Sjölund B. The ventral spino-olivocerebellar system in the cat. V. Supraspinal control of spinal transmission. Exp Brain Res. 1978 Nov 15;33(3-4):509-22. — View Citation

Smits H, van Kleef M, Holsheimer J, Joosten EA. Experimental spinal cord stimulation and neuropathic pain: mechanism of action, technical aspects, and effectiveness. Pain Pract. 2013 Feb;13(2):154-68. doi: 10.1111/j.1533-2500.2012.00579.x. Epub 2012 Jul 1 — View Citation

Somers DL, Clemente FR. Contralateral high or a combination of high- and low-frequency transcutaneous electrical nerve stimulation reduces mechanical allodynia and alters dorsal horn neurotransmitter content in neuropathic rats. J Pain. 2009 Feb;10(2):221 — View Citation

Stevanato G, Devigili G, Eleopra R, Fontana P, Lettieri C, Baracco C, Guida F, Rinaldo S, Bevilacqua M. Chronic post-traumatic neuropathic pain of brachial plexus and upper limb: a new technique of peripheral nerve stimulation. Neurosurg Rev. 2014 Jul;37( — View Citation

Svendsen F, Rygh LJ, Gjerstad J, Fiskå A, Hole K, Tjølsen A. Recording of long-term potentiation in single dorsal horn neurons in vivo in the rat. Brain Res Brain Res Protoc. 1999 Jul;4(2):165-72. — View Citation

Telles JD, Gabanela Schiavon MA, Rampazo da Silva ÉP, Liebano RE. Transcutaneous electrical nerve stimulation and cervical joint manipulation on pressure pain threshold. Pain Manag. 2018 Jul 1;8(4):263-269. doi: 10.2217/pmt-2017-0069. Epub 2018 Jun 1. — View Citation

Tompra N, van Dieën JH, Coppieters MW. Central pain processing is altered in people with Achilles tendinopathy. Br J Sports Med. 2016 Aug;50(16):1004-7. doi: 10.1136/bjsports-2015-095476. Epub 2015 Dec 23. — View Citation

Toprak U, Selvi NA, Ates A, Erhuner Z, Bostanoglu S, Karademir MA, Karaaslan Y. Dynamic Doppler evaluation of the hand arteries of the patients with Raynaud's disease. Clin Rheumatol. 2009 Jun;28(6):679-83. doi: 10.1007/s10067-009-1131-1. Epub 2009 Feb 24. — View Citation

Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499. Review. — View Citation

Von Frey M (1896). Untersuchung und ¨ber die Sinnesfunktionen der menschlichen Haut. Erste Abhandlung: Druckempfindung und Schmerz. Abhandlungen der mathematischphysischen Klasse der Königlichen Sa ¨chsischen Gesellschaft der Wissenschaften;. p. 23.

Weinstein S (1968). Intensive and extensive aspects of tactile sensitivity as a function of body part, sex, and laterality. In: Kenshalo D, Springfield R, Thomas C, editors. The skin senses. p. 195- 222.

Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11. — View Citation

Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. Review. — View Citation

Yang F, Zhang C, Xu Q, Tiwari V, He SQ, Wang Y, Dong X, Vera-Portocarrero LP, Wacnik PW, Raja SN, Guan Y. Electrical stimulation of dorsal root entry zone attenuates wide-dynamic-range neuronal activity in rats. Neuromodulation. 2015 Jan;18(1):33-40; disc — View Citation

Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. — View Citation

* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed	Pre-intervention / baseline
Primary	Mechanical Threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed.	Immediately after the intervention
Primary	Mechanical Threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of mechanical sensation, that caliber is considered the pressure threshold to elicit mechanical. The test is performed with subject's eyes closed.	24 hours after the intervention
Primary	Pinprick pain threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed	pre-intervention / baseline
Primary	Pinprick pain threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed	Immediately after the intervention
Primary	Pinprick pain threshold elicited with Von Frey Filaments	We use Von Frey Filaments of increasing caliber to make pression in the evaluated areas. When the test subject reports perception of pinprick sensation, that caliber is considered the pressure threshold to elicit pinprick pain. The test is performed with subject's eyes closed	24 hours after the intervention
Primary	Pain evocated with Von Frey Filaments.	We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.	Pre-intervention / baseline
Primary	Pain evocated with Von Frey Filaments.	We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.	Immediately after the intervention
Primary	Pain evocated with Von Frey Filaments.	We use Von Frey Filaments of increasing caliber to make pression with 100g, 180g and 300g in the evaluated areas. Each filament to make pression three times. The subject reports the pain in a scale of 0-10 number (scale NSR: 0 is any pain and 10 is the maximal perception of pain. The test is performed with subject's eyes closed.	24 hours after the intervention
Primary	Pressure pain threshold with algometer.	On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.	pre-intervention / baseline
Primary	Change in pressure pain threshold with algometer.	On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.	Immediately after the intervention
Primary	Change in pressure pain threshold with algometer.	On the marked areas we make pressure with pressure algometer. When the subject experiences any sense of pain, he/she has to say "stop" and immediately the algometer was removed. The number in Kg marked by the algometer is annotated. The mean of two measurements was taken for analysis. The second measurement was taken with a minimum of 30 seconds after the previous one.	24 hours after the intervention
Primary	Maximum grip force with dynamometer	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	pre-intervention / baseline
Primary	Change in maximum grip force with dynamometer	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	Immediately after the intervention
Primary	Change in maximum grip force with dynamometer.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	24 hours after the intervention
Primary	Maximum grip force with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	pre-intervention / baseline
Primary	Change in maximum grip force with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	Immediately after the intervention
Primary	Change in maximum grip force with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during 5 second, 3 times with 30 seconds to rest between them.	24 hours after the intervention
Primary	Arterial peak systolic velocity with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.	pre-intervention / baseline
Primary	Change in arterial peak systolic velocity with Color Doppler Ultrasonography in placebo group	In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles inmediately after introduce the needly in the arm.	Immediately after the needle insertion
Primary	Change in arterial peak systolic velocity with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial peak systolic during 5 cardiac cycles.	Immediately after the intervention
Primary	Arterial volume flow with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.	pre-intervention / baseline
Primary	Change in arterial volume flow with Color Doppler Ultrasonography	In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.	Immediately after the needle insertion
Primary	Change in arterial volume flow with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial volume flow during 5 cardiac cycles.	Immediately after the intervention
Secondary	Electric current threshold of perception with low frequency	Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	pre-intervention / baseline
Secondary	Change in Electric current threshold of perception with low frequency	Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	Immediately after the intervention
Secondary	Change in Electric current threshold of perception with low frequency	Using the intervention needle as an active electrode. The parameters are 2 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	24 hours after the intervention
Secondary	Electric current threshold of perception with high frequency	Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	pre-intervention / baseline
Secondary	Change electric current threshold of perception with high frequency	Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	Immediately after the intervention
Secondary	Change electric current threshold of perception with high frequency	Using the intervention needle as an active electrode. The parameters are 100 hz and 150 msec of pulse duration and the intensity was increased progressively. When the subject experienced any sense of pain, sensitivity and muscle contraction in the needle and arm, he/she must tell it and the threshold is annotated.	24 hours after the intervention
Secondary	Force grip resistance with dynamometer	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	Pre-intervention / Baseline
Secondary	Change in Force grip resistance with dynamometer.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	Immediately after the intervention
Secondary	Change in Force grip resistance with dynamometer.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	24 hours after the intervention
Secondary	Force grip resistance with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	Pre-intervention / Baseline
Secondary	Change in Force grip resistance with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	Immediately after the intervention
Secondary	Change in Force grip resistance with surface electromyography.	The subject is standing with the dynamometer in his hand. He/she must press the dynamometer during one minute trying to maintain maximal force.	24 hours after the intervention
Secondary	Neural tension test (ROM)	The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome	pre-intervention / baseline
Secondary	Change in neural tension test (ROM)	The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome	Immediately after the intervention
Secondary	Change in neural tension test (ROM)	The subject is lying on the stretcher. We make a neurodynamic test and when she/he experience tension in his/her arm, she/he must tell us "stop". We measure the range of motion of the elbow extension as the outcome	24 hours after the intervention
Secondary	Change in arterial end-diastolic velocity with Color Doppler Ultrasonography	In the placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.	Immediately after the needle insertion
Secondary	Arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.	pre-intervention / baseline
Secondary	Change in arterial time average mean velocity during cardiac cycle with Color Doppler Ultrasonography	In the placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.	Immediately after the needle insertion
Secondary	Arterial end-diastolic velocity with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.	pre-intervention / baseline
Secondary	Change in arterial end-diastolic velocity with Color Doppler Ultrasonography	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial end-diastolic velocity during 5 cardiac cycles.	Immediately after the intervention
Secondary	Change in arterial time average mean velocity during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average mean velocity during 5 cardiac cycles.	Immediately after the intervention
Secondary	Arterial time average maximun velocity during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.	pre-intervention / baseline
Secondary	Change in arterial time average maximun velocity during cardiac cycle with Color Doppler	In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.	Immediately after the needle insertion
Secondary	Change in arterial time average maximun velocity during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial time average maximun velocity during 5 cardiac cycles.	Immediately after the intervention
Secondary	Arterial pulsatility index during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.	pre-intervention / baseline
Secondary	Change in arterial pulsatility index during cardiac cycle with Color Doppler	In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.	Immediately after the needle insertion
Secondary	Change in arterial pulsatility index during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial pulsatility index during 5 cardiac cycles.	Immediately after the intervention
Secondary	Arterial arterial resistivity index during cardiac cycle with Color Doppler	In placebo group, on the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.	pre-intervention / baseline
Secondary	Change in arterial resistivity index during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.	Immediately after the needle insertion
Secondary	Change in arterial resistivity index during cardiac cycle with Color Doppler	On the marked areas (Brachial ipsilateral and contralateral, radial and ulnar arteries) we measure the arterial resistivity index during 5 cardiac cycles.	Immediately after the intervention