Muscle Tone AbnormalitiesNCT02575586
Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
A study testing Intervention-Dry Needling in people with Muscle Tone Abnormalities, run by University of Castilla-La Mancha at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Abnormalities
- What is being tested?
- Intervention-Dry Needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Fear of needles.
- No tolerance to pain caused by dry needling.
- No continuance commitment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Tone Abnormalities
- Being tested
- Intervention-Dry Needling, Control-Dry Needling
- Keywords
- Trigger Points, Dry needling, Torque, H-Reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-Dry NeedlingDevice
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 NeedlingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling into MTrPs. | Experimental | Intervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle. Receives: 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). Receives: Device: Control-Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Passive resistive torque to ankle dorsiflexion.
Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.
Measured: 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).
Measured: 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.
Measured: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Secondary outcomes (3)
Change in Maximal voluntary isometric force.
Maximal voluntary isometric force test of Triceps Surae muscle and Tibialis Anterior muscle.
Measured: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in H reflex.
Maximal H reflex, H reflex threshold and normalized H at 25% Mmax.
Measured: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in M response.
Maximal M wave and M wave threshold.
Measured: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Tone AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
- Responsible party
- Sponsor
- Investigators
- Julio Gomez Soriano, PhD, Study director, University of Castilla-La ManchaCarolina Jiménez Sánchez, MSc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575586
- Sponsor's protocol ID
- 83
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34284646
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Deep Dry Needling on Muscle Tone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02575586
- Acronym / sponsor ID
- 83
- Conditions
- Muscle Tone Abnormalities
- Keywords
- Trigger Points, Dry needling, Torque, H-Reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling into MTrPs. | Experimental | Device: Intervention-Dry NeedlingIntervention-Dry Needling: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle. |
| Dry Needling out of MTrPs. | Active comparator | Device: Control-Dry NeedlingControl-Dry Needling: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention-Dry NeedlingDeep 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. | Device | Dry Needling into MTrPs. |
| Control-Dry NeedlingDeep 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. | Device | Dry Needling out of MTrPs. |
Primary outcome
Change in Passive resistive torque to ankle dorsiflexion.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Passive resistive torque to ankle dorsiflexion at slow (10º/s) and fast (180º/s) velocities.
Change in Dorsiflexion passive range of motion.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Ratio between maximal H-reflex and maximal M-wave.
3 secondary outcomes
Change in Maximal voluntary isometric force.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in H reflex.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Change in M response.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 34284646Jimenez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Gomez Soriano, PhD study director
University of Castilla-La Mancha
Carolina Jiménez Sánchez, MSc principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-Dry Needling in people with Muscle Tone Abnormalities, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Passive resistive torque to ankle dorsiflexion. (time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.