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Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

Primary Purpose

Muscle Tone Abnormalities

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

About this trial

This is an interventional basic science trial for Muscle Tone Abnormalities focused on measuring Myofascial Trigger Points, Dry needling, Myotonometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad San Jorge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling into MTrPs.

Dry Needling within Taut Band

Arm Description

MTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.

TB Group: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band; out of MTrPs).

Outcomes

Primary 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 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 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.

Secondary Outcome Measures

Pain perception after intervention using Visual Analogical Scale.
Pain perception after intervention using Visual Analogical Scale (VAS).
Number of Local Twitch Responses.
Number of local twitch responses during intervention.

Full Information

First Posted
October 29, 2016
Last Updated
May 11, 2023
Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
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1. Study Identification

Unique Protocol Identification Number
NCT02952053
Brief Title
Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?
Official Title
Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 12, 2015 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Abnormalities
Keywords
Myofascial Trigger Points, Dry needling, Myotonometry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling into MTrPs.
Arm Type
Experimental
Arm Description
MTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
Arm Title
Dry Needling within Taut Band
Arm Type
Active Comparator
Arm Description
TB Group: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band; out of MTrPs).
Intervention Type
Device
Intervention Name(s)
MTrP Group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TB Group
Intervention Description
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.
Primary 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
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Secondary Outcome Measure Information:
Title
Pain perception after intervention using Visual Analogical Scale.
Description
Pain perception after intervention using Visual Analogical Scale (VAS).
Time Frame
After intervention (Day 1).
Title
Number of Local Twitch Responses.
Description
Number of local twitch responses during intervention.
Time Frame
During intervention (Day 1).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Gomez Soriano, PhD
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
María Ortiz Lucas, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carolina Jiménez Sánchez, MSc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad San Jorge
City
Villanueva de Gállego
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

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