Trigger Point Pain, MyofascialNCT04466813
Effect of Dry Needling on Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points
A study testing Intervention-Dry Needling in people with Trigger Point Pain, Myofascial, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether application of Dry Needling (DN) is effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with cross-control design. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Intervention-Dry Needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2020to 20 Oct 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years
- The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
- Being able to provide written informed consent
- Being able to follow instructions and realize clinical tests
Who cannot join
- Any pharmacological therapeutic
- Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
- Any history of head and upper extremity surgery or trauma
- Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
- Absence of recurrent history of neck pain
- No neck pain symptomatology the previous 6 months
- Cervical disk herniation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dry Needling on Stiffness in Latent Trigger Points a Randomized Controlled Trial
The purpose of this study is to determine whether application of Dry Needling (DN) is effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected to DN group or Sham-Dn group.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Intervention-Dry Needling, Control-Dry Needling
- Keywords
- Latent trigger point, Dry needling, Myotonometer, Tensiomyography
- Medical subject headings
- Myofascial Pain Syndromes
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 Trigger Point of the upper trapezius muscle.
1 session in upper trapezius muscle moving the needle up and down ten times.
Control-Dry NeedlingDevice
Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
| Study group | Role | What they receive |
|---|---|---|
| Deep Dry Needling | Experimental | Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle Receives: Device: Intervention-Dry Needling |
| Sham Dry Needling | Sham comparator | Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle Receives: Device: Control-Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Maximal Radial Displacement (Dm)
This outcome measure is obtained by a device named Tensiomiography. The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in millimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary outcomes (9)
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: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Mechanical Stress Relaxation Time [ms]
This outcome measure is obtained by a device named MyotonPro. Mechanical Stress Relaxation Time [ms] is the time for a muscle to recover tis shape from deformation after a voluntary contraction or a removal of an external force.
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)
This outcome measure is obtained by a device named MyotonPro. Ratio of deformation and Relaxation time, characterising Creep (Deborah number) is the gradual elongation of a tissue over time when placed under a constant tensile stress.
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Contraction time (Tc)
This outcome measure is obtained by a device named Tensiomiography. Contraction time (Tc) as a time between 10% and 90% of the contraction
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Delay time (Td)
This outcome measure is obtained by a device named Tensiomiography. Delay time (Td) as a time between the electrical impulse and 10% of the contraction
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Sustain time (Ts)
This outcome measure is obtained by a device named Tensiomiography. Sustain time (Ts) as a time between 50% of the contraction and 50% of the relaxation
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Relaxation time (Tr)
This outcome measure is obtained by a device named Tensiomiography. Relaxation time (Tr) as a time between 90% and 50% of the relaxation
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pressure Pain Perception (PPP)
Change in Pain Pressure Threshold (PPT) as assessed using an manual mechanical algometer. The procedure performed was the same as the prior described, but pressure was kept until 2.5 kg/cm2 and maintained for 5 seconds, whereas the subject had to characterize the level of pain using a 10-mm visual analog scale (VAS)
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start20 Jul 2020
- Primary completion20 Sep 2020
- Study completion20 Oct 2020
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 Trigger Point Pain, MyofascialStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Abián-Vicén, PhD, Study director, Castilla-La Mancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466813
- Sponsor's protocol ID
- DNMYOTMG
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of dry needling on mechanical and contractile properties of the upper trapezius with latent myofascial trigger points: A randomized controlled trial. Musculoskelet Sci Pract. 2021 Dec;56:102456. doi: 10.1016/j.msksp.2021.102456. Epub 2021 Sep 3.
PubMed 34507046
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Stiffness in Latent Trigger Points a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04466813
- Acronym / sponsor ID
- DNMYOTMG
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- Latent trigger point, Dry needling, Myotonometer, Tensiomyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- 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 purpose of this study is to determine whether application of Dry Needling (DN) is effective for improved Muscle Mechanical Properties and Muscle Contractility in Latent Trigger Points point (LTrP) of upper trapezius. Randomized controlled trial, in parallel with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly selected to DN group or Sham-Dn group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Dry Needling | Experimental | Device: Intervention-Dry NeedlingIntervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle |
| Sham Dry Needling | Sham comparator | Device: Control-Dry NeedlingControl-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 30 years
- The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
- Being able to provide written informed consent
- Being able to follow instructions and realize clinical tests
Key exclusion criteria (7 listed)
- Any pharmacological therapeutic
- Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
- Any history of head and upper extremity surgery or trauma
- Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
- Absence of recurrent history of neck pain
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 Trigger Point of the upper trapezius muscle. 1 session in upper trapezius muscle moving the needle up and down ten times. | Device | Deep Dry Needling |
| Control-Dry NeedlingSham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles | Device | Sham Dry Needling |
Primary outcome
Change in Stiffness
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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 Maximal Radial Displacement (Dm)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
This outcome measure is obtained by a device named Tensiomiography. The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in millimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.
9 secondary outcomes
Change in Oscillation Frequency
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Decrement (elasticity)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Mechanical Stress Relaxation Time [ms]
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Ratio of deformation and Relaxation time, characterising Creep (Deborah number)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Contraction time (Tc)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Delay time (Td)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Sustain time (Ts)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Relaxation time (Tr)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pressure Pain Perception (PPP)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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 23 Oct 2020.
- Derived from this study: PubMed 34507046Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of dry needling on mechanical and contractile properties of the upper trapezius with latent myofascial trigger points: A randomized controlled trial. Musculoskelet Sci Pract. 2021 Dec;56:102456. doi: 10.1016/j.msksp.2021.102456. Epub 2021 Sep 3.
- 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.
Javier Abián-Vicén, PhD study director
Castilla-La Mancha University
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 Trigger Point Pain, Myofascial, 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 4 inclusion and 7 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 23 Oct 2020. 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. Some participants in this study may receive a placebo. 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 Stiffness (time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment). The study lists 2 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 NCT04466813, 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 23 Oct 2020.