Effect of Dry Needling on Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points

October 22, 2020 updated by: University of Castilla-La Mancha

Effects of Dry Needling on Stiffness in Latent Trigger Points a Randomized Controlled Trial

The purpose of this study is to determine whether application of Dry Needling (DN) is effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected to DN group or Sham-Dn group.

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.

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
      • Toledo, Spain, 45071
        • Performance and Sport Rehabilitation Laboratory

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 30 years
  • The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
  • Being able to provide written informed consent
  • Being able to follow instructions and realize clinical tests

Exclusion Criteria:

  • Any pharmacological therapeutic
  • Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
  • Any history of head and upper extremity surgery or trauma
  • Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
  • Absence of recurrent history of neck pain
  • No neck pain symptomatology the previous 6 months
  • Cervical disk herniation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Deep Dry Needling
Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle
Device: Intervention-Dry Needling

Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.

1 session in upper trapezius muscle moving the needle up and down ten times.
Sham Comparator: Sham Dry Needling
Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle
Device: Control-Dry Needling
Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles

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 Stiffness
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Maximal Radial Displacement (Dm)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in millimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

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 Oscillation Frequency
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Decrement (elasticity)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Mechanical Stress Relaxation Time [ms]
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named MyotonPro. Mechanical Stress Relaxation Time [ms] is the time for a muscle to recover tis shape from deformation after a voluntary contraction or a removal of an external force.
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named MyotonPro. Ratio of deformation and Relaxation time, characterising Creep (Deborah number) is the gradual elongation of a tissue over time when placed under a constant tensile stress.
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Contraction time (Tc)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. Contraction time (Tc) as a time between 10% and 90% of the contraction
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Delay time (Td)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. Delay time (Td) as a time between the electrical impulse and 10% of the contraction
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Sustain time (Ts)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Relaxation time (Tr)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. Relaxation time (Tr) as a time between 90% and 50% of the relaxation
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pressure Pain Perception (PPP)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pain Pressure Threshold (PPT) as assessed using an manual mechanical algometer. The procedure performed was the same as the prior described, but pressure was kept until 2.5 kg/cm2 and maintained for 5 seconds, whereas the subject had to characterize the level of pain using a 10-mm visual analog scale (VAS)
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

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

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: Javier Abián-Vicén, PhD, Castilla-La Mancha University

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 (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.
July 20, 2020

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.
September 20, 2020

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.
October 20, 2020

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).
July 6, 2020

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.
July 6, 2020

First Posted (Actual)

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.
July 10, 2020

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 23, 2020

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 22, 2020

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.
July 1, 2020

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.
  • DNMYOTMG

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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