Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

May 11, 2023 updated by: University of Castilla-La Mancha

The main objective of this study is to assess effects of Dry Needling into Myofascial Trigger Point compared Dry Needling into Taut Band point based on the outcomes of myotnometric measurement in healthy subjects.

Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling of the Taut Band of the soleus muscle.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Methods:

It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo older than 18 years.

There will be a MTrP Group (dry needling into the medial MTrP of soleus muscle) and a TB Group (dry needling distal to the MTrP but into the taut muscle band of soleus muscle). The intervention will be a unique session.

Intervention:

Dry needling technique will be performed by locating the taut band and the Myofascial Trigger Point. Depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the Myofascial Trigger Point or within the Taut Band.

Assessment:

Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. Myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle.

The device incorporates a probe and an acceleration sensor. The probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 N and a local deformation in the order of a few millimetres) are delivered to MTrP and TB points.

Outcome measures:

Outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) and they will be evaluated before, at 10 min and 1 week after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Villanueva de Gállego, Spain, 50830
        • Universidad San Jorge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age range 18-40 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.

Exclusion Criteria:

  • 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 intervention.
  • Peripheral or central nervous system neurological disease.
  • Altered sensitivity in the treatment area.
  • Treatment of a myofascial trigger point in the sural triceps in the six months previous to the intervention.
  • Changes in physical activity which would have affected muscle tone during the study.
  • Fear of needles.
  • No tolerance to pain caused by dry needling.
  • No continuance commitment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dry Needling into MTrPs.
MTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
Device: MTrP Group

Deep Dry Needling into the site of the latent medial Myofascial Trigger Point of the soleus muscle.

1 session in soleus muscle. 10 fast in and fast out needle insertions.
Active Comparator: Dry Needling within Taut Band
TB Group: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band; out of MTrPs).
Device: TB Group

Deep Dry Needling distal to Myofascial Trigger Point but into the same taut band.

1 session in soleus muscle. 10 fast in and fast out needle insertions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Oscillation Frequency.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in Stiffness.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in Decrement (elasticity).
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
This outcome measure is obtained by a device named MyotonPro.The logarithmic decrement of the damping oscillations characterizes muscle elasticity which is the ability of the muscle to restore its initial shape after contraction.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain perception after intervention using Visual Analogical Scale.
Time Frame: After intervention (Day 1).
Pain perception after intervention using Visual Analogical Scale (VAS).
After intervention (Day 1).
Number of Local Twitch Responses.
Time Frame: During intervention (Day 1).
Number of local twitch responses during intervention.
During intervention (Day 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Castilla-La Mancha

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad San Jorge
Hospital Nacional de Parapléjicos de Toledo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: María Ortiz Lucas, PhD, Universidad San Jorge
  • Study Director: Julio Gomez Soriano, PhD, University of Castilla-La Mancha
  • Principal Investigator: Carolina Jiménez Sánchez, MSc, Universidad San Jorge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 134b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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