NCT03154632

Brief Summary

The main objective: To compare the effect on muscle tone between the application of digital capacitive diathermy and the application of ultrasound on the myofascial trigger points (MTP) of the upper trapezius muscle. Hypothesis: The application of digital capacitive diathermy on myofascial trigger points of the trapezius muscle compared to the application of ultrasound produces objective changes in muscle tone, and this change is superior to the changes generated by the US.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

May 2, 2017

Last Update Submit

May 2, 2018

Conditions

Muscle Tonus

Keywords

Myofascial trigger pointTrapezius MuscleDiathermyUltrasound

Outcome Measures

Primary Outcomes (3)

  • Change in Stiffness

    The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

  • Change in Decrement (elasticity)

    Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

  • Change in Frequency

    Frequency of muscle oscillations (Hz) is an indicator of the tone. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle. The assessment is realized in these points: * MTrP 1 of the affected superior trapezius. * MTrP 3 of the affected superior trapezius. * MTrP 1 of the NO affected superior trapezius. * Point in the middle of the muscle belly of the affected superior trapezius. 10 mechanical stimuli of 0.4 N of force and 0.15 ms of duration will be applied. The MyotonPro® must remain perpendicular to the surface to be measured (the subject will be lying in a prone position for the MTrP 3, and sit down for the three other points). Each assessment will consist of 10 multiple measurements, spaced for 1 second. To be considerate as valid, the variation coefficient of the measure should not exceed 3%.

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

Secondary Outcomes (4)

  • Change in the Pressure Pain Threshold (PPT)

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

  • Change in the Range Of Motion (ROM) of cervical spine lateral inclination

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

  • Change in Pain Perception

    Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).

  • Change in Neck Disability Index (NDI)

    Pre-intervention; Follow up (1 week after the intervention).

Study Arms (2)

US Group

ACTIVE COMPARATOR

Ultrasound Therapy

Device: Ultrasound Therapy

DCD Group

ACTIVE COMPARATOR

Digital Capacitive Diathermy Therapy

Device: Digital Capacitive Diathermy Therapy

Interventions

Ultrasound TherapyDEVICE

Ultrasound equipment will be used, choosing a continuous mode, with a frequency of 1MHz and an intensity of 1.0 W/cm2. The technique will be applied during 6 minutes with circular movements and a speed of approximately between 2.5 and 4 centimeters per second.

US Group
Digital Capacitive Diathermy TherapyDEVICE

The DCD equipment will be used choosing the "musculotendinous injury FAST" program which lasts 6 minutes. The applicator will move with a velocity approximately between 2.5 and 4 centimeters per second.

DCD Group

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years
  • Presence of an active or latent MTrP 1 in the upper trapezius:
  • Presence of taut band in a skeletal muscle.
  • Presence of a hypersensitive point in the taut band.
  • Local twitch response caused by palpation of the taut band.
  • Reproduction of the typical referred pain pattern of MTrPs in response to compression.
  • Spontaneous presence of the typical pain pattern and/or patient's recognition of that pain as familiar (criteria only applicable to the active MTrPs).

You may not qualify if:

  • History of neurological disorders (radiculopathy).
  • Cervical surgery.
  • Chronic pain in any part of the body as a result of a traumatic incident.
  • Chronic rheumatic disease.
  • Medical diagnosis of fibromyalgia.
  • Systemic diseases.
  • Actual pregnancy.
  • Clinical depression.
  • Body mass index ≥30.
  • To receive treatment of myofascial syndrome in the muscles of the cervico-dorsal area (physical therapy, invasive techniques ...) during the month prior to the beginning of the study.
  • Ingestion of medication (analgesics, muscle relaxants, psychotropic or anti-inflammatory agents) in the three days prior to the start of the study.
  • Exit criteria:
  • Patient´s petition.
  • Appearance of any lesion that might contraindicate the use of electrotherapy techniques.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, 50830, Spain

Location

MeSH Terms

Conditions

Fever

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Carolina Jiménez-Sánchez, MSc

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

  • Maria Ortiz-Lucas, PhD

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 16, 2017

Study Start

February 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 15, 2017

Last Updated

May 3, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)