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Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02575586
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Hospital Nacional de Parapléjicos de Toledo
Universidad San Jorge
Information provided by (Responsible Party):
University of Castilla-La Mancha

Study Description
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Brief Summary:

The main objective of this study is to analyze the effect of dry needling of the soleus muscle to modulate muscle tone in healthy non-injured subjects. The secondary objective is to study if effects occur due to changes in the neural or mechanical component (or both).

Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the soleus muscle produces changes in muscle tone varying the passive resistance torque at a rate of 180º/ s.


Condition or disease Intervention/treatment Phase
Muscle Tone Abnormalities Device: Intervention-Dry Needling Device: Control-Dry Needling Not Applicable

Detailed Description:

Methods:

It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo between 18 and 40 years.

There will be an intervention group (dry needling into the medial MTrP of soleus muscle) and a control 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. After that, a thin needle (0,32x40mm) is introduced directly into a Myofascial Trigger Point with the aims to generate a "local twitch response" that are involuntary contractions of the muscle fibers. This puncture may reproduce patient's symptoms, and causes muscle relaxation to achieve at the same time the relief of muscle tension and pain and also to recover the metabolism of the muscle.

Assessment:

The mechanical and the neural properties of muscle tone were evaluated using an isokinetic dynamometry and H-reflex test measurement, respectively Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects.

The H-reflex has been utilized as a probe to study neurophysiological phenomena. This measurement can be used to assess the response of the nervous system to various neurologic conditions, musculoskeletal injuries, application of therapeutic modalities, pain, exercise training, and performance of motor tasks.

Outcome measures:

Outcome measures will include passive resistive torque to ankle dorsiflexion, dorsiflexion passive range of motion (PROM), maximal isometric voluntary force (MIVF) and H-reflex and M-response measurements and they will be evaluated before, at 10 min and 1 week after the intervention.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dry Needling into MTrPs.
Intervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
 Device: Intervention-Dry Needling

Deep Dry Needling into the site of the latent medial Myofascial Trigger Point of the soleus muscle.

1 session in soleus muscle moving the needle up and down ten times.
Active Comparator: Dry Needling out of MTrPs.
Control-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band).
 Device: Control-Dry Needling

Deep Dry Needling distal to Myofascial Trigger Point but into the same taut band.

1 session in soleus muscle moving the needle up and down ten times.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Passive resistive torque to ankle dorsiflexion. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.

  2. Change in Dorsiflexion passive range of motion. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Soleus muscle extensibility (Dorsiflexion angle of ankle obtained by a force of 200 N and by the maximal tolerated force applied to gastrocnemius muscles).

  3. Change in Ratio Hmax/Mmax. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Ratio between maximal H-reflex and maximal M-wave.


Secondary Outcome Measures :
  1. Change in Maximal voluntary isometric force. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.

  2. Change in H reflex. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.

  3. Change in M response. [ Time Frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention). ]
    Maximal M wave and M wave threshold.


Other Outcome Measures:
  1. Pain perception after intervention using Visual analogical scale. [ Time Frame: After intervention (Day 1). ]
    Pain perception after intervention using Visual analogical scale (VAS).

  2. Number of Local twitch responses. [ Time Frame: During intervention (Day 1). ]
    Number of local twitch responses during intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575586


Locations
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Spain
Toledo Hospital
Toledo, Spain
Sponsors and Collaborators
University of Castilla-La Mancha
Hospital Nacional de Parapléjicos de Toledo
Universidad San Jorge
Investigators
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Study Director: Julio Gomez Soriano, PhD University of Castilla-La Mancha
Principal Investigator: Carolina Jiménez Sánchez, MSc Universidad San Jorge
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT02575586    
Other Study ID Numbers: 83
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Castilla-La Mancha:
Trigger Points
Dry needling
Torque
H-Reflex
Additional relevant MeSH terms:
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Congenital Abnormalities