Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
1 other identifier
interventional
46
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 20, 2017
October 1, 2015
2 months
October 9, 2015
October 18, 2017
Conditions
Keywords
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.
EXPERIMENTALIntervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle.
Dry Needling out of MTrPs.
ACTIVE COMPARATORControl-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band).
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.
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.
Eligibility Criteria
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
- University of Castilla-La Manchalead
- Hospital Nacional de Parapléjicos de Toledocollaborator
- Universidad San Jorgecollaborator
Study Sites (1)
Toledo Hospital
Toledo, Spain
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.
PMID: 34284646DERIVED
Study Officials
- STUDY DIRECTOR
Julio Gomez Soriano, PhD
University of Castilla-La Mancha
- PRINCIPAL INVESTIGATOR
Carolina Jiménez Sánchez, MSc
Universidad San Jorge
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