Clinical trial NCT04710992: Influence of Percutaneous Electrolysis on Endogenous Pain Modulation
Official title: Influence of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Electric Stimulation Therapy
Randomized Clinical Trial
Interventional Ultrasonography
Percutaneous Electrolysis
Endogenous Pain Modulation
Pain
Conditioned Pain Modulation
Sensory Thresholds
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.


Eligibility criteria: Inclusion Criteria:

* Healthy asymptomatic subjects
* Aged 18 to 40 years
* Both genders

Exclusion Criteria:

* Belonephobia or fear of needles
* Neurological, cardiovascular or metabolic diseases
* Any pathology or process that causes pain
* Cutaneous alterations
* Pregnancy
* Cognitive and sensitivity disorders
* Fibromyalgia
* Frequent or recent (24 hours before) intake of alcohol and other drugs
* Have received pharmacological, physiotherapeutic or other treatment in the last week
* Intake of caffeine in the two hours prior to measurement
* Vigorous physical activity on the day of testing

Primary outcomes:
measure: Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Change from baseline Pressure Pain Thresholds immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca
Study officials:
References:
citation: Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.
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: 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: Nir RR, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care. 2015 Jun;9(2):131-7. doi: 10.1097/SPC.0000000000000126.
citation: Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
citation: Damien J, Colloca L, Bellei-Rodriguez CE, Marchand S. Pain Modulation: From Conditioned Pain Modulation to Placebo and Nocebo Effects in Experimental and Clinical Pain. Int Rev Neurobiol. 2018;139:255-296. doi: 10.1016/bs.irn.2018.07.024. Epub 2018 Aug 14.