Muscle Tone AbnormalitiesNCT02919150
Myotonometric Measurement of Myofascial Trigger Points: Reliability, Validity and Sensitivity
An observational study of Muscle Tone Abnormalities, run by University of Castilla-La Mancha.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Abnormalities
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects must be healthy volunteers and will be recruited from the city of Toledo.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
Read the detailed description
Previous researches have used complicated and expensive methods to measure mechanical properties of muscle tone like isokinetic dynamometer.
The purpose of this investigation is to establish the reliability, validity and sensitivity of a myotonometer to assess myofascial trigger points. The results of this study will verify the inter-reliability of a myotonometer device in order to evaluate muscle tone, examine correlations and associations between myotonometric measurements and isokinetic measurements and provide a measurable understanding of the location of myofascial trigger points.
Assessment:
Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone.
Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects but isokinetic machine is a heavy and expensive equipment.
Outcome measures:
Myotonometric measures will include muscle frequency, decrement (elasticity) and stiffness.
Isokinetic measures will include passive resistive torque to ankle dorsiflexion and dorsiflexion passive range of motion (PROM)
All outcome measures will be evaluated once.
- Conditions
- Muscle Tone Abnormalities
- Keywords
- Myofascial Trigger Points, Myotonometry, Isokinetic Dynamometry, Assessment, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Correlation between myotonometric measurement and isokinetic measurement
Relationships among myotonometric parameters and isokinetic parameters
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start1 Nov 2016
- Primary completion1 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
- Responsible party
- Sponsor
- Investigators
- Julio Gomez Soriano, PhD, Study director, University of Castilla-La ManchaCarolina Jiménez Sánchez, MSc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919150
- Sponsor's protocol ID
- 134a
- Status last verified
- Nov 2016
- First submitted
- 27 Sep 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myotonometric Measurement of Myofascial Trigger Points: Reliability, Validity and Sensitivity
- ClinicalTrials.gov ID
- NCT02919150
- Acronym / sponsor ID
- 134a
- Conditions
- Muscle Tone Abnormalities
- Keywords
- Myofascial Trigger Points, Myotonometry, Isokinetic Dynamometry, Assessment, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Previous researches have used complicated and expensive methods to measure mechanical properties of muscle tone like isokinetic dynamometer.
The purpose of this investigation is to establish the reliability, validity and sensitivity of a myotonometer to assess myofascial trigger points. The results of this study will verify the inter-reliability of a myotonometer device in order to evaluate muscle tone, examine correlations and associations between myotonometric measurements and isokinetic measurements and provide a measurable understanding of the location of myofascial trigger points.
Assessment:
Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone.
Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects but isokinetic machine is a heavy and expensive equipment.
Outcome measures:
Myotonometric measures will include muscle frequency, decrement (elasticity) and stiffness.
Isokinetic measures will include passive resistive torque to ankle dorsiflexion and dorsiflexion passive range of motion (PROM)
All outcome measures will be evaluated once.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects must be healthy volunteers and will be recruited from the city of Toledo.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-rater reliability of myotonometric measurement
Time frame: Day 1
In order to study the interrater reliability of the myoton, two different evaluators assess the muscle tone within two marked points using the myotonometer
Correlation between myotonometric measurement and isokinetic measurement
Time frame: Day 1
Relationships among myotonometric parameters and isokinetic parameters
Sensitivity of distinguishing the localisation of myofascial trigger points within the taut band
Time frame: Day 1
Ability to identify and differentiate myofascial trigger points and other points within the taut band using the myotonometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Muscle Tone Abnormalities
Active, not recruitingObservational study
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Arrest of Bone Development or Growth, Constitutional Delay of Growth and Puberty
Recruiting
Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Muscle Tone, Muscle Strength
Not yet recruiting
Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients
Flexible Flatfoot, Knee Pain
Active, not recruiting
Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
Skin Lax and Muscle Strength
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Gomez Soriano, PhD study director
University of Castilla-La Mancha
Carolina Jiménez Sánchez, MSc principal investigator
Universidad San Jorge
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Tone Abnormalities, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability of myotonometric measurement (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.