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Analgesic Mechanisms of Percutaneous Electrolysis

Primary Purpose

Percutaneous Electrolysis, Pain, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sham intervention
Low intensity percutaneous electrolysis
High intensity percutaneous electrolysis
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Percutaneous Electrolysis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham intervention

Low intensity percutaneous electrolysis

High intensity percutaneous electrolysis

Arm Description

The needle will be inserted for 90 seconds without galvanic current.

Galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.

Participants will receive three impacts of galvanic current with an intensity of 3 mA for 3 seconds each.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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

Full Information

First Posted
October 16, 2021
Last Updated
February 14, 2022
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05097937
Brief Title
Analgesic Mechanisms of Percutaneous Electrolysis
Official Title
Neurophysiological Effects of Percutaneous Electrolysis Related to Endogenous Pain Modulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Electrolysis, Pain, Analgesia, Pain Modulation, Endogenous Analgesia System

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham intervention
Arm Type
Sham Comparator
Arm Description
The needle will be inserted for 90 seconds without galvanic current.
Arm Title
Low intensity percutaneous electrolysis
Arm Type
Experimental
Arm Description
Galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
Arm Title
High intensity percutaneous electrolysis
Arm Type
Experimental
Arm Description
Participants will receive three impacts of galvanic current with an intensity of 3 mA for 3 seconds each.
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.
Intervention Type
Other
Intervention Name(s)
Low intensity percutaneous electrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity percutaneous electrolysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in Pressure Pain Thresholds (PPT)
Description
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).
Time Frame
Baseline and immediately after the intervention
Secondary Outcome Measure Information:
Title
Changes from baseline in Conditioned Pain Modulation (CPM)
Description
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).
Time Frame
Baseline and immediately after the intervention
Title
Changes from baseline in Temporal Summation (TS)
Description
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
Time Frame
Baseline and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29777953
Citation
de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria 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.
Results Reference
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PubMed Identifier
28135129
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.
Results Reference
background
PubMed Identifier
23801002
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.
Results Reference
background
PubMed Identifier
24821478
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.
Results Reference
background
PubMed Identifier
24477495
Citation
Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) 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.
Results Reference
background
PubMed Identifier
25330039
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.
Results Reference
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Analgesic Mechanisms of Percutaneous Electrolysis

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