- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466813
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- 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
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Toledo, Spain, 45071
- Performance and Sport Rehabilitation Laboratory
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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
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 |
Intervention / Treatment |
|---|---|
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Experimental: Deep Dry Needling
Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle
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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. |
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Sham Comparator: Sham Dry Needling
Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle
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Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Stiffness
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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This outcome measure is obtained by a device named MyotonPro.
Stiffness reflects the resistance of the muscle to the force deforming the muscle.
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Maximal Radial Displacement (Dm)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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.
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Secondary Outcome Measures
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
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This outcome measure is obtained by a device named MyotonPro.
The frequency of the damped oscillations characterizes the muscle tone.
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Decrement (elasticity)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
|
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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
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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.
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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
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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.
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Contraction time (Tc)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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This outcome measure is obtained by a device named Tensiomiography.
Contraction time (Tc) as a time between 10% and 90% of the contraction
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Delay time (Td)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Sustain time (Ts)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
|
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Change in Relaxation time (Tr)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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This outcome measure is obtained by a device named Tensiomiography.
Relaxation time (Tr) as a time between 90% and 50% of the relaxation
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Pressure Pain Perception (PPP)
Time Frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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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)
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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)
July 20, 2020
Primary Completion (Actual)
September 20, 2020
Study Completion (Actual)
October 20, 2020
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 6, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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