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CompletedNCT02952053Updated May 12, 2023

Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

An interventional study of MTrP Group and TB Group in Muscle Tone Abnormalities, sponsored by University of Castilla-La Mancha. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2015, registered Oct 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Tone Abnormalities

Keywords

  • Myofascial Trigger Points
  • Dry needling
  • Myotonometry
03

In context

Lead sponsor

University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Dry Needling into MTrPs.

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

    Device: MTrP Group

  • 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

Interventions

  • DeviceMTrP 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.

  • DeviceTB 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.

06

What researchers measure

Primary outcomes

  1. Change in Oscillation Frequency.

    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).

  2. 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.

    Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).

  3. 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.

    Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).

Secondary outcomes

  1. Pain perception after intervention using Visual Analogical Scale.

    Pain perception after intervention using Visual Analogical Scale (VAS).

    Time frame: After intervention (Day 1).

  2. Number of Local Twitch Responses.

    Number of local twitch responses during intervention.

    Time frame: During intervention (Day 1).

07

Study locations

1 site
  • Universidad San Jorge
    Villanueva de Gállego, 50830, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Jul 2017, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2016
First posted
Nov 2, 2016
StartActual
Dec 12, 2015
Primary completionActual
Jul 1, 2017
CompletionActual
Jul 31, 2017
Last update
May 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952053
Collaborators
Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
Responsible party
Sponsor
First posted
Nov 2, 2016
Start date
Dec 12, 2015
Primary completion
Jul 1, 2017
Completion
Jul 31, 2017
Last update
May 12, 2023

Study contacts

Julio Gomez Soriano, PhD
study director · University of Castilla-La Mancha
María Ortiz Lucas, PhD
study director · Universidad San Jorge
Carolina Jiménez Sánchez, MSc
principal investigator · Universidad San Jorge

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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