Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

The main objective of this study is to assess effects of Dry Needling into Myofascial Trigger Point compared Dry Needling into Taut Band point based on the outcomes of myotnometric measurement in healthy subjects.

Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling of the Taut Band of the soleus muscle.

Study Overview

• Status: Completed
• Conditions: Muscle Tone Abnormalities
• Intervention / Treatment: Device: MTrP Group; Device: TB Group

Detailed Description

Methods:

It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo older than 18 years.

There will be a MTrP Group (dry needling into the medial MTrP of soleus muscle) and a TB 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. Depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the Myofascial Trigger Point or within the Taut Band.

Assessment:

Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. Myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle.

The device incorporates a probe and an acceleration sensor. The probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 N and a local deformation in the order of a few millimetres) are delivered to MTrP and TB points.

Outcome measures:

Outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) and they will be evaluated before, at 10 min and 1 week after the intervention.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Villanueva de Gállego, Spain, 50830
    • Universidad San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling into MTrPs.; MTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.	Device: MTrP Group; Deep Dry Needling into the site of the latent medial Myofascial Trigger Point of the soleus muscle. 1 session in soleus muscle. 10 fast in and fast out needle insertions.
Active Comparator: Dry Needling within Taut Band; TB Group: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band; out of MTrPs).	Device: TB Group; Deep Dry Needling distal to Myofascial Trigger Point but into the same taut band. 1 session in soleus muscle. 10 fast in and fast out needle insertions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oscillation Frequency.	This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception after intervention using Visual Analogical Scale.	Pain perception after intervention using Visual Analogical Scale (VAS).	After intervention (Day 1).
Number of Local Twitch Responses.	Number of local twitch responses during intervention.	During intervention (Day 1).

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Universidad San Jorge; Hospital Nacional de Parapléjicos de Toledo
• Investigators: Study Director: María Ortiz Lucas, PhD, Universidad San Jorge; Study Director: Julio Gomez Soriano, PhD, University of Castilla-La Mancha; Principal Investigator: Carolina Jiménez Sánchez, MSc, Universidad San Jorge

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: October 29, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Dry needling; Myofascial Trigger Points; Myotonometry
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 134b

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