Analgesic Mechanisms of Percutaneous Electrolysis

Sponsor
University of Salamanca (Other)
Overall Status
Completed
CT.gov ID
NCT05097937
Collaborator
(none)
54
1
3
2.7
20.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sham intervention
  • Other: Low intensity percutaneous electrolysis
  • Other: High intensity percutaneous electrolysis
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Neurophysiological Effects of Percutaneous Electrolysis Related to Endogenous Pain Modulation
Actual Study Start Date :
Nov 22, 2021
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham intervention

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

Other: Sham intervention
The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.

Experimental: Low intensity percutaneous electrolysis

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

Other: 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.

Experimental: High intensity percutaneous electrolysis

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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Changes from baseline in Pressure Pain Thresholds (PPT) [Baseline and immediately after the intervention]

    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

  1. Changes from baseline in Conditioned Pain Modulation (CPM) [Baseline and immediately after the intervention]

    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).

  2. Changes from baseline in Temporal Summation (TS) [Baseline and immediately after the intervention]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sergio Varela Rodríguez, PhD candidate, University of Salamanca
ClinicalTrials.gov Identifier:
NCT05097937
Other Study ID Numbers:
  • EP550
First Posted:
Oct 28, 2021
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022