NCT02919150

Brief Summary

The aims of this study are:

  • To examine the inter-rater reliability to assess myofascial trigger points using a myotonometer
  • To determinate the strength of the correlation between myotonometric parameters and isokinetic parameters
  • To evaluate the sensitivity of myotonometric measurements to detect the location of myofascial trigger points

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

October 20, 2017

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

September 27, 2016

Last Update Submit

October 18, 2017

Conditions

Keywords

Myofascial Trigger PointsMyotonometryIsokinetic DynamometryAssessmentReliability

Outcome Measures

Primary Outcomes (3)

  • Inter-rater reliability of myotonometric measurement

    In order to study the interrater reliability of the myoton, two different evaluators assess the muscle tone within two marked points using the myotonometer

    Day 1

  • Correlation between myotonometric measurement and isokinetic measurement

    Relationships among myotonometric parameters and isokinetic parameters

    Day 1

  • Sensitivity of distinguishing the localisation of myofascial trigger points within the taut band

    Ability to identify and differentiate myofascial trigger points and other points within the taut band using the myotonometer

    Day 1

Study Arms (1)

Myotonometric and isokinetic measurement

Myotonometric assessment: into the site of the latent medial myofascial trigger point of the soleus muscle and distal to the lateral medial myofascial trigger point of the soleus muscle but into the same taut band. Isokinetic assessment: triceps surae muscle tone will be quantified by measuring the passive range of motion for ankle dorsiflexion and the resistance to passive ankle dorsiflexion at slow and fast velocity.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects must be healthy volunteers and will be recruited from the city of Toledo.

You may qualify if:

  • Age range 18-55 years.
  • Healthy volunteers.
  • Presence of a latent medial MTrP of the soleus muscle.
  • Being able to provide written informed consent.
  • Being able to follow instructions and realize clinical tests.

You may not qualify if:

  • Any history of ipsilateral lower limb severe injury or intervention (e.g. fracture, surgical intervention).
  • Pain or musculoskeletal injury, ligament injury, tendonitis or plantar fasciitis in the ipsilateral leg for six months previous to the evaluation.
  • Peripheral or central nervous system neurological disease.
  • Altered sensitivity in the studied area.
  • Treatment of a myofascial trigger point in the sural triceps in the six months previous to the evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Julio Gomez Soriano, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR
  • Carolina Jiménez Sánchez, MSc

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 31, 2017

Last Updated

October 20, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share