NCT02952053

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

December 12, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

May 12, 2023

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

October 29, 2016

Last Update Submit

May 11, 2023

Conditions

Muscle Tone Abnormalities

Keywords

Myofascial Trigger PointsDry needlingMyotonometry

Outcome Measures

Primary Outcomes (3)

  • 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 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

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

Device: MTrP Group

Dry Needling within Taut Band

ACTIVE COMPARATOR

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

MTrP GroupDEVICE

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.

Dry Needling into MTrPs.
TB GroupDEVICE

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.

Dry Needling within Taut Band

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Universidad San Jorge

Villanueva de Gállego, 50830, Spain

Location

Study Officials

  • Julio Gomez Soriano, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR

  • María Ortiz Lucas, PhD

    Universidad San Jorge

    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 29, 2016

First Posted

November 2, 2016

Study Start

December 12, 2015

Primary Completion

July 1, 2017

Study Completion

July 31, 2017

Last Updated

May 12, 2023

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)