Analgesic Mechanisms of Percutaneous Electrolysis

Pain Clinical Trial

Official title:

Neurophysiological Effects of Percutaneous Electrolysis Related to Endogenous Pain Modulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097937
• Other study ID #: EP550
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2022
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Percutaneous electrolysis is based on the application of a galvanic current through an acupuncture needle. The underlying mechanisms that explain the efficacy of this technique are not completely well understood. The objective is to delve into the neurophysiological analgesic effects of percutaneous electrolysis. Participants will be assigned to one of three intervention groups. The analgesic effects of the technique will be evaluated by means of variables related to endogenous pain modulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Asymptomatic subjects

• Signature of the informed consent

Exclusion Criteria:

• Fear of needles

• Any pathology or process that causes pain

• Neurological, rheumatologic, cardiovascular or metabolic diseases

• Cutaneous alterations and cognitive or sensitivity disorders

• Pregnancy

• Recent intake of alcohol or caffeine

• Vigorous physical activity on the day of testing

Related Conditions & MeSH terms

• Analgesia
• Pain
• Pain Modulation

Intervention

Other:
• Sham intervention
The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.
• Low intensity percutaneous electrolysis
A single impact of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 0.3 mA for 90 seconds.
• High intensity percutaneous electrolysis
Three impacts of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 3 mA and a duration of 3 seconds each.

Locations

Country	Name	City	State
Spain	Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibañez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI®) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30. — View Citation

Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, García-Herreros S, Monllau JC, Sanchez-Ibánez 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. — View 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. Review. — View Citation

de Miguel Valtierra L, Salom Moreno J, Fernández-de-Las-Peñas C, Cleland JA, Arias-Buría JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16. — View Citation

García 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. — View Citation

Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Pressure Pain Thresholds (PPT)	PPTs will be measure by algometry in the common extensor tendon of the epicondyle, bicipital groove and tibialis anterior muscle (all of the right side).	Baseline and immediately after the intervention
Secondary	Changes from baseline in Conditioned Pain Modulation (CPM)	CPM will be assess by upper extremity submaximal effort tourniquet test with algometric measures in the common extensor tendon of the epicondyle, bicipital groove and tibialis anterior muscle (all of the right side).	Baseline and immediately after the intervention
Secondary	Changes from baseline in Temporal Summation (TS)	Assessed by Verbal Numeric Rating Scale (11-point). 10 consecutive pressures will be applied in the three previous locations (epicondyle, bicipital groove and tibialis anterior) with the algometer at the intensity of the pressure pain threshold	Baseline and immediately after the intervention