NCT02575586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 9, 2015

Last Update Submit

October 18, 2017

Conditions

Keywords

Trigger PointsDry needlingTorqueH-Reflex

Outcome Measures

Primary Outcomes (3)

  • Change in Passive resistive torque to ankle dorsiflexion.

    Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.

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

  • Change in Dorsiflexion passive range of motion.

    Soleus muscle extensibility (Dorsiflexion angle of ankle obtained by a force of 200 N and by the maximal tolerated force applied to gastrocnemius muscles).

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

  • Change in Ratio Hmax/Mmax.

    Ratio between maximal H-reflex and maximal M-wave.

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

Secondary Outcomes (3)

  • Change in Maximal voluntary isometric force.

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

  • Change in H reflex.

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

  • Change in M response.

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

Other Outcomes (2)

  • Pain perception after intervention using Visual analogical scale.

    After intervention (Day 1).

  • Number of Local twitch responses.

    During intervention (Day 1).

Study Arms (2)

Dry Needling into MTrPs.

EXPERIMENTAL

Intervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.

Device: Intervention-Dry Needling

Dry Needling out of MTrPs.

ACTIVE COMPARATOR

Control-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band).

Device: Control-Dry Needling

Interventions

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.

Dry Needling into MTrPs.

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.

Dry Needling out of MTrPs.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toledo Hospital

Toledo, Spain

Location

Related Publications (1)

  • Jimenez-Sanchez C, Gomez-Soriano J, Bravo-Esteban E, Mayoral-Del Moral O, Herrero-Gallego P, Ortiz-Lucas M. The effect of dry needling of myofascial trigger points on muscle stiffness and motoneuron excitability in healthy subjects. Acupunct Med. 2022 Feb;40(1):24-33. doi: 10.1177/09645284211027579. Epub 2021 Jul 20.

Study Officials

  • Julio Gomez Soriano, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR
  • Carolina Jiménez Sánchez, MSc

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 14, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2017

Last Updated

October 20, 2017

Record last verified: 2015-10

Data Sharing

IPD Sharing
Will not share

Locations