Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

October 18, 2017 updated by: University of Castilla-La Mancha

The main objective of this study is to analyze the effect of dry needling of the soleus muscle to modulate muscle tone in healthy non-injured subjects. The secondary objective is to study if effects occur due to changes in the neural or mechanical component (or both).

Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the soleus muscle produces changes in muscle tone varying the passive resistance torque at a rate of 180º/ s.

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 between 18 and 40 years.

There will be an intervention group (dry needling into the medial MTrP of soleus muscle) and a control 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. After that, a thin needle (0,32x40mm) is introduced directly into a Myofascial Trigger Point with the aims to generate a "local twitch response" that are involuntary contractions of the muscle fibers. This puncture may reproduce patient's symptoms, and causes muscle relaxation to achieve at the same time the relief of muscle tension and pain and also to recover the metabolism of the muscle.

Assessment:

The mechanical and the neural properties of muscle tone were evaluated using an isokinetic dynamometry and H-reflex test measurement, respectively Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects.

The H-reflex has been utilized as a probe to study neurophysiological phenomena. This measurement can be used to assess the response of the nervous system to various neurologic conditions, musculoskeletal injuries, application of therapeutic modalities, pain, exercise training, and performance of motor tasks.

Outcome measures:

Outcome measures will include passive resistive torque to ankle dorsiflexion, dorsiflexion passive range of motion (PROM), maximal isometric voluntary force (MIVF) and H-reflex and M-response measurements 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.
46

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
      • Toledo, Spain
        • Toledo Hospital

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 to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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
  • 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.
Intervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
Device: Intervention-Dry Needling

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

1 session in soleus muscle moving the needle up and down ten times.
Active Comparator: Dry Needling out of MTrPs.
Control-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band).
Device: Control-Dry Needling

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

1 session in soleus muscle moving the needle up and down ten times.

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 Passive resistive torque to ankle dorsiflexion.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in Dorsiflexion passive range of motion.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Soleus muscle extensibility (Dorsiflexion angle of ankle obtained by a force of 200 N and by the maximal tolerated force applied to gastrocnemius muscles).
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in Ratio Hmax/Mmax.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Ratio between maximal H-reflex and maximal M-wave.
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
Change in Maximal voluntary isometric force.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in H reflex.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in M response.
Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Maximal M wave and M wave threshold.
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
October 1, 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.
December 1, 2015

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.
June 1, 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 9, 2015

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.
October 12, 2015

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.
October 14, 2015

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.
October 20, 2017

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.
October 18, 2017

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, 2015

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.
  • 83

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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