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
About this trial
This is an interventional basic science trial for Percutaneous Electrolysis
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
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
NCT ID
NCT05097937
First Posted
October 16, 2021
Last Updated
February 14, 2022
Sponsor
University of Salamanca
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
background
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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