Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

Muscle Tone Abnormalities Clinical Trial

Official title:

Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575586
• Other study ID #: 83
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 18, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2015
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Tone Abnormalities

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Toledo Hospital	Toledo

Sponsors (3)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain perception after intervention using Visual analogical scale.	Pain perception after intervention using Visual analogical scale (VAS).	After intervention (Day 1).
Other	Number of Local twitch responses.	Number of local twitch responses during intervention.	During intervention (Day 1).
Primary	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).
Primary	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).
Primary	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	Change in Maximal voluntary isometric force.	Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Secondary	Change in H reflex.	Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Secondary	Change in M response.	Maximal M wave and M wave threshold.	Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).