Muscle Tone AbnormalitiesNCT02952053
Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?
A study testing MTrP Group and TB Group 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 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Abnormalities
- What is being tested?
- MTrP Group and TB Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2015to 31 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Show all 9Show fewer
- 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 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.
Read the detailed description
Methods:
It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo older than 18 years.
There will be a MTrP Group (dry needling into the medial MTrP of soleus muscle) and a TB 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. Depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the Myofascial Trigger Point or within the Taut Band.
Assessment:
Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. Myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle.
The device incorporates a probe and an acceleration sensor. The probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 N and a local deformation in the order of a few millimetres) are delivered to MTrP and TB points.
Outcome measures:
Outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) and they will be evaluated before, at 10 min and 1 week after the intervention.
- Conditions
- Muscle Tone Abnormalities
- Being tested
- MTrP Group, TB Group
- Keywords
- Myofascial Trigger Points, Dry needling, Myotonometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling into MTrPs. | Experimental | MTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle. Receives: 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). Receives: Device: TB Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oscillation Frequency.
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
Measured: 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.
Measured: 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.
Measured: 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.
Pain perception after intervention using Visual Analogical Scale (VAS).
Measured: After intervention (Day 1).
Number of Local Twitch Responses.
Number of local twitch responses during intervention.
Measured: During intervention (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start12 Dec 2015
- Primary completion1 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 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 ManchaMaría Ortiz Lucas, PhD, Study director, Universidad San JorgeCarolina Jiménez Sánchez, MSc, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952053
- Sponsor's protocol ID
- 134b
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2016
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?
- ClinicalTrials.gov ID
- NCT02952053
- Acronym / sponsor ID
- 134b
- Conditions
- Muscle Tone Abnormalities
- Keywords
- Myofascial Trigger Points, Dry needling, Myotonometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Universidad San Jorge
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 2 Nov 2016 (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 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.
Detailed description
Methods:
It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo older than 18 years.
There will be a MTrP Group (dry needling into the medial MTrP of soleus muscle) and a TB 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. Depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the Myofascial Trigger Point or within the Taut Band.
Assessment:
Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. Myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle.
The device incorporates a probe and an acceleration sensor. The probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 N and a local deformation in the order of a few millimetres) are delivered to MTrP and TB points.
Outcome measures:
Outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) 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: MTrP GroupMTrP Group: Deep Dry Needing into the medial Myofascial Trigger Point of the soleus muscle. |
| Dry Needling within Taut Band | Active comparator | Device: TB GroupTB Group: Deep Dry Needling distal to Myofascial Trigger Point of the soleus muscle (in the same taut band; out of MTrPs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| MTrP GroupDeep 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. | Device | Dry Needling into MTrPs. |
| TB GroupDeep 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. | Device | Dry Needling within Taut Band |
Primary outcome
Change in Oscillation Frequency.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
This outcome measure is obtained by a device named MyotonPro. The frequency of the damped oscillations characterizes the muscle tone.
Change in Stiffness.
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
This outcome measure is obtained by a device named MyotonPro. Stiffness reflects the resistance of the muscle to the force deforming the muscle.
Change in Decrement (elasticity).
Time frame: Pre-intervention (Day 1); After intervention (Day 1); Follow up (1 week after intervention).
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.
2 secondary outcomes
Pain perception after intervention using Visual Analogical Scale.
Time frame: After intervention (Day 1).
Number of Local Twitch Responses.
Time frame: During intervention (Day 1).
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 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Muscle Tone Abnormalities
Active, not recruitingObservational study
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Arrest of Bone Development or Growth, Constitutional Delay of Growth and Puberty
Recruiting
Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Muscle Tone, Muscle Strength
Not yet recruiting
Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients
Flexible Flatfoot, Knee Pain
Active, not recruiting
Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
Skin Lax and Muscle Strength
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
María Ortiz Lucas, PhD study director
Universidad San Jorge
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 MTrP Group and TB Group 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 12 May 2023. 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 Oscillation Frequency. (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?
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 12 May 2023.