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NCT03636386: MEP

Percutaneous Microelectrolysis on Myofascial Trigger Points Pain.

Completed NA Results posted Last updated 18 April 2023
What this trial tests

NA trial testing Percutaneous microelectrolysis in Myofascial Trigger Point Pain (MTrP) in 48 participants. Completed in 4 September 2019.

Timeline
23 May 2018
Primary endpoint
14 December 2018
4 September 2019

Quick facts

Lead sponsorQuiropraxia y Equilibrio
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment48
Start date23 May 2018
Primary completion14 December 2018
Estimated completion4 September 2019
Sites1 location across Chile

Drugs / interventions tested

Conditions studied

Sponsor

Quiropraxia y Equilibrio

Who can join

18 and older, any sex, with Myofascial Trigger Point Pain (MTrP). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Pressure Threshold (PPT) Primary · PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each session

Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.

PPTpre1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)1.4± 0.2
Control Group (Ultrasound Therapy)1.4± 0.2
PPTpost1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)1.6± 0.2
Control Group (Ultrasound Therapy)1.6± 0.2
PPT2
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)1.7± 0.1
Control Group (Ultrasound Therapy)1.6± 0.2
PPT3
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)1.9± 0.3
Control Group (Ultrasound Therapy)1.7± 0.2
PPTdiff1-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)0.2± 0.2
Control Group (Ultrasound Therapy)0.2± 0.1
PPTdiff2-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)0.4± 0.2
Control Group (Ultrasound Therapy)0.2± 0.2
PPTdiff3-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)0.5± 0.4
Control Group (Ultrasound Therapy)0.3± 0.3
Pain Intensity (PI) Secondary · PIpre1 (baseline), PIpost1 (post baseline), PI2 (Day 3), PI3 (Day 7), assessed an average of 3 minutes at each session

Magnitude of pain expressed in millimeters (mm) referred by participants. PI was evaluated through visual analogue scale at moment of performing pressure algometry test in the sensitive point of upper trapezius muscle. PI was assessed with an analogous visual scale where the participant will mark the pain generated by the algometry on a scale of 1 to 100 millimeters. PI was valued in four occasions: PI1 pre (baseline), PI1 post, PI 2 (at day 3) and PI 3 (at day 7).

PIpre1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)32.1± 13.6
Control Group (Ultrasound Therapy)31.4± 15.1
PIpost1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)24.6± 12.7
Control Group (Ultrasound Therapy)24.8± 15.1
PI2
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)21.6± 11.0
Control Group (Ultrasound Therapy)23.8± 14.0
PI3
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)18.1± 9.9
Control Group (Ultrasound Therapy)20.0± 13.2
PIdiff1-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)-7.5± 8.4
Control Group (Ultrasound Therapy)-6.6± 8.6
PIdiff2-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)-10.5± 11.9
Control Group (Ultrasound Therapy)-7.6± 12.1
PIdiff3-1
GroupValue95% CI
Percutaneous Microelectrolysis Group (MEP)-14.0± 12.3
Control Group (Ultrasound Therapy)-11.5± 13.1

Sponsor's own description

The aim of the design is to investigate the value of percutaneous microelectrolysis (MEP) as an analgesic technique in myofascial trigger points. This research seeks to evaluate influence of cathode polar effects on the reduction of painful pressure (PPT) threshold and pain intensity (PI) in the myofascial trigger points (MTrPs) of upper trapezius muscle. An assessment with algometry and visual analog scale (VAS) will be made before applying the intervention. The study will evaluate changes in PPT and PI in a group exposed to percutaneous microelectrolysis (MEP) aplication compared to control group. Both groups will be provided with a baseline treatment of therapeutic ultrasound. Treatment will include three evaluation sessions. Subsequently, researchers will proceed to compare PPT and PI obtained from algometry test and VAS in each groups, and between groups, before and after the intervention. Changes obtained between sessions will be compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Myofascial Trigger Point Pain (MTrP)

Currently open trials in the same condition.

Other Quiropraxia y Equilibrio trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03636386.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing