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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04466813
Other study ID # DNMYOTMG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date October 20, 2020

Study information

Verified date July 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 20, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

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.
Control-Dry Needling
Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles

Locations

Country Name City State
Spain Performance and Sport Rehabilitation Laboratory Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Stiffness 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
Primary Change in Maximal Radial Displacement (Dm) 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 Change in Oscillation Frequency 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
Secondary Change in Decrement (elasticity) 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
Secondary Change in Mechanical Stress Relaxation Time [ms] 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
Secondary Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number) 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
Secondary Change in Contraction time (Tc) 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
Secondary Change in Delay time (Td) 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
Secondary Change in Sustain time (Ts) 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
Secondary Change in Relaxation time (Tr) 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
Secondary Change in Pressure Pain Perception (PPP) 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
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