search
Back to results

Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

Primary Purpose

Muscle Tone Abnormalities

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention-Dry Needling
Control-Dry Needling
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 Trigger Points, Dry needling, Torque, H-Reflex

Eligibility Criteria

18 Years - 40 Years (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

  • Toledo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling into MTrPs.

Dry Needling out of MTrPs.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Passive resistive torque to ankle dorsiflexion.
Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.
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).
Change in Ratio Hmax/Mmax.
Ratio between maximal H-reflex and maximal M-wave.

Secondary Outcome Measures

Change in Maximal voluntary isometric force.
Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.
Change in H reflex.
Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.
Change in M response.
Maximal M wave and M wave threshold.

Full Information

First Posted
October 9, 2015
Last Updated
October 18, 2017
Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
search

1. Study Identification

Unique Protocol Identification Number
NCT02575586
Brief Title
Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
Official Title
Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 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

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Abnormalities
Keywords
Trigger Points, Dry needling, Torque, H-Reflex

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dry Needling into MTrPs.
Arm Type
Experimental
Arm Description
Intervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
Arm Title
Dry Needling out of MTrPs.
Arm Type
Active Comparator
Arm Description
Control-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band).
Intervention Type
Device
Intervention Name(s)
Intervention-Dry Needling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control-Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Passive resistive torque to ankle dorsiflexion.
Description
Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Title
Change in Dorsiflexion passive range of motion.
Description
Soleus muscle extensibility (Dorsiflexion angle of ankle obtained by a force of 200 N and by the maximal tolerated force applied to gastrocnemius muscles).
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Title
Change in Ratio Hmax/Mmax.
Description
Ratio between maximal H-reflex and maximal M-wave.
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Secondary Outcome Measure Information:
Title
Change in Maximal voluntary isometric force.
Description
Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Title
Change in H reflex.
Description
Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Title
Change in M response.
Description
Maximal M wave and M wave threshold.
Time Frame
Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Other Pre-specified Outcome Measures:
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
Maximum Age & Unit of Time
40 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
Carolina Jiménez Sánchez, MSc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toledo Hospital
City
Toledo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34284646
Citation
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.
Results Reference
derived

Learn more about this trial

Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

We'll reach out to this number within 24 hrs