NCT04390438

Brief Summary

Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS. This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry needling control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 30, 2020

Last Update Submit

May 13, 2020

Conditions

Keywords

Patellofemoral pain syndromeElectrolysisMyofascial Pain SyndromesAcupuncture

Outcome Measures

Primary Outcomes (2)

  • Pressure Pain Threshold (Trigger Point)

    Algometry (Wagner analogical algometer)

    7 days

  • Pressure Pain Threshold (Patellar Tendon)

    Algometry (Wagner analogical algometer)

    7 days

Secondary Outcomes (1)

  • Subjective pain perception

    7 days

Study Arms (3)

High-Intensity short time percutaneous electrolysis

EXPERIMENTAL

Application of a 0,66uA galvanic current in the active TrP through a needle during 10 seconds. During the 20 seconds left necessary to blind the patient and the examiner, the needle was inside but with no electrical current

Procedure: Percutaneous Electrolysis

Low-Intensity long time percutaneous electrolysis

EXPERIMENTAL

Application of a 0,22uA galvanic current in the active TrP through a needle during 30 seconds

Procedure: Percutaneous Electrolysis

Dry needling

ACTIVE COMPARATOR

One acupuncture needle was placed in the active TrP to produce a local twitch response during 30 seconds

Procedure: Dry needling

Interventions

Needle emplacement with a galvanic electrical current

High-Intensity short time percutaneous electrolysisLow-Intensity long time percutaneous electrolysis
Dry needlingPROCEDURE

Needle emplacement without electrical current nor substance

Dry needling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes with knee pain
  • Presence of at least one active Trigger point

You may not qualify if:

  • Farmacologic treatment
  • Surgery or traumas
  • Skin alterations or infections
  • Prior 6 weeks DN nor PT treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camilo Jose Cela University

Villanueva de la Cañada, Madrid, 28692, Spain

Location

MeSH Terms

Conditions

MyalgiaPatellofemoral Pain SyndromeMyofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Juan Antonio Valera-Calero, PT, Msc

    Camilo Jose Cela University

    PRINCIPAL INVESTIGATOR
  • Alberto Sanchez-Mayoral-Martín, PT

    Free professional practice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical trial with 3 parallel groups; 2 experimental groups and 1 control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 15, 2020

Study Start

February 17, 2020

Primary Completion

March 30, 2020

Study Completion

April 27, 2020

Last Updated

May 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations