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

Primary Purpose

Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention-Dry Needling
Control-Dry Needling
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring Latent trigger point, Dry needling, Myotonometer, Tensiomyography

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Performance and Sport Rehabilitation Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Deep Dry Needling

Sham Dry Needling

Arm Description

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

Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Oscillation Frequency
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
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
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.
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.
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
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
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
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
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)

Full Information

First Posted
July 6, 2020
Last Updated
October 22, 2020
Sponsor
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT04466813
Brief Title
Effect of Dry Needling on Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points
Official Title
Effects of Dry Needling on Stiffness in Latent Trigger Points a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
Keywords
Latent trigger point, Dry needling, Myotonometer, Tensiomyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Dry Needling
Arm Type
Experimental
Arm Description
Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle
Arm Title
Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle
Intervention Type
Device
Intervention Name(s)
Intervention-Dry Needling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control-Dry Needling
Intervention Description
Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
Primary Outcome Measure Information:
Title
Change in Stiffness
Description
This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Maximal Radial Displacement (Dm)
Description
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.
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary Outcome Measure Information:
Title
Change in Oscillation Frequency
Description
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Decrement (elasticity)
Description
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
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Mechanical Stress Relaxation Time [ms]
Description
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.
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)
Description
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.
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Contraction time (Tc)
Description
This outcome measure is obtained by a device named Tensiomiography. Contraction time (Tc) as a time between 10% and 90% of the contraction
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Delay time (Td)
Description
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
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Sustain time (Ts)
Description
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
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Relaxation time (Tr)
Description
This outcome measure is obtained by a device named Tensiomiography. Relaxation time (Tr) as a time between 90% and 50% of the relaxation
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Title
Change in Pressure Pain Perception (PPP)
Description
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)
Time Frame
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Abián-Vicén, PhD
Organizational Affiliation
Castilla-La Mancha University
Official's Role
Study Director
Facility Information:
Facility Name
Performance and Sport Rehabilitation Laboratory
City
Toledo
ZIP/Postal Code
45071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34507046
Citation
Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of dry needling on mechanical and contractile properties of the upper trapezius with latent myofascial trigger points: A randomized controlled trial. Musculoskelet Sci Pract. 2021 Dec;56:102456. doi: 10.1016/j.msksp.2021.102456. Epub 2021 Sep 3.
Results Reference
derived

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

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