NCT03025230

Brief Summary

Hypothesis The application of intramuscular electrostimulation will be more effectiveness than the dry needling in myofascial trigger points treatment. Objetives: To determine the effectiveness of intramuscular electrostimulation in the treatment of trigger points of the levator scapula muscle for the improvement of pain in mechanical cervicalgia. Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and active trigger points in levator scapulae muscle, randomly assigned to experimental or control group. Intervention: Control group: one session of dry needling in active trigger points; experimental group: one session of intramuscular stimulation in active trigger points. Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion and strength muscle . The measures will be taken before, after and one week after the interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

January 16, 2017

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold (PPT)

    An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points

    Change from baseline at one week

Secondary Outcomes (2)

  • Pain Visual Analogue Scale

    Change from baseline at one week

  • Strength in cervical latero-flexion

    Change from baseline at one week

Study Arms (2)

Experimental group

EXPERIMENTAL

Dry needling technique and the application of a rectangular, biphasic, asymmetric analgesic electric current by selecting a frequency of 2 Hz with a pulse width 40 μs, with an intensity located at the tolerance threshold and for a time of 20 minutes.

Other: Dry needling and electric stimulation

Control group

ACTIVE COMPARATOR

Dry technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.

Other: Dry needling

Interventions

Dry needling technique and the application of electric stimulation of levator scapulae PG

Experimental group

Treatment of PG with a filiform needle in levator scapulae muscle

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cervical pain.
  • Active trigger points in levator scapulae muscle

You may not qualify if:

  • Pain Irradiation toward upper limb
  • Psychological disorders
  • Whiplash.
  • Neuropathic symptoms
  • Cervical and / or Shoulder Spine Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia Martínez Merinero

Alcalá de Henares, Madrid, 28806, Spain

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesMyalgia

Interventions

Dry NeedlingElectric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPhysical StimulationInvestigative Techniques

Study Officials

  • Tomás Gallego-Izquierdo, Doctor

    Alcala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pecos-Martin, Daniel (Principal Investigator)

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 19, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations