Trigger Point Pain, MyofascialNCT04684784
Effect of Dry Needling on Surface Electromyographic Activity 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
Brief summary: The purpose of this study is to determine the effect of Dry Needling (DN) on electromyographic activity in different situations at the latent trigger point (LTrP) point of the upper trapezius. Randomized controlled trial, in parallel with the crossover 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
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jan 2021to 18 Feb 2021
- 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 onthe 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
Brief summary: The purpose of this study is to determine the effect of Dry Needling (DN) on electromyographic activity in different situations at the latent trigger point (LTrP) point of the upper trapezius. Randomized controlled trial, in parallel with the crossover control design. Two groups with LTrP in the upper trapezius, and the DN group or the Sham-Dn group will be randomly selected.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Intervention-Dry Needling, Control-Dry Needling
- Keywords
- Dry needling, Electromyography, Latent trigger point
- 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 TriggerPoint 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 | Placebo 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.
Changes in resting surface EMG activity (amplitude, RMS)
EMG activity (RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG ME 6000 TE(Mega Electronics, Kuopio, Finland). Resting EMG activity will be expressed as a percentage of maximal reference contractions of the upper trapezius (% reference contractions).
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Secondary outcomes (4)
Changes in resting surface EMG activity (Median frequency, MF)
EMG activity (RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG ME 6000 TE(Mega Electronics, Kuopio, Finland).
EMG median frequency will be used to determine the endurance of the upper trapezius. The EMG median frequency will be measured in Hertz (Hz).
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Changes in submaximal contrations surface EMG activity of upper trapezius (amplitude, RMS)
EMG activity (RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG ME 6000 TE(Mega Electronics, Kuopio, Finland).
EMG activity of submaximal contractions will be expressed as a percentage of submaximal reference contractions of the upper trapezius (% reference contractions).
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 7submaximal contractions EMG activity will be expressed as a percentage of maximal reference contractions of the upper trapezius (% reference contractions).2 hours after treatment
Changes in submaximal contrations surface EMG activity of upper trapezius (Median frequency, MF)
EMG activity (RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG ME 6000 TE(Mega Electronics, Kuopio, Finland).
EMG median frequency will be used to determine the endurance of the upper trapezius. The EMG median frequency will be measured in Hertz (Hz).
Measured: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pain Pressure Threshold (PPT)
Pressure-Pain Threshold as assessed by an manual mechanical algometer. PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.
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 posted28 Dec 2020
- Study start4 Jan 2021
- Primary completion4 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 46 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, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684784
- Sponsor's protocol ID
- DNEMG
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Needling on Surface Electromyographic Activity in Latent Trigger Points
- ClinicalTrials.gov ID
- NCT04684784
- Acronym / sponsor ID
- DNEMG
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- Dry needling, Electromyography, Latent trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 28 Dec 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.
Brief summary: The purpose of this study is to determine the effect of Dry Needling (DN) on electromyographic activity in different situations at the latent trigger point (LTrP) point of the upper trapezius. Randomized controlled trial, in parallel with the crossover control design. Two groups with LTrP in the upper trapezius, and the DN group or the Sham-Dn group will be randomly selected.
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 | Placebo 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 onthe 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 TriggerPoint 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
Changes in resting surface EMG activity (amplitude, RMS)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
EMG activity (RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG ME 6000 TE(Mega Electronics, Kuopio, Finland). Resting EMG activity will be expressed as a percentage of maximal reference contractions of the upper trapezius (% reference contractions).
4 secondary outcomes
Changes in resting surface EMG activity (Median frequency, MF)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Changes in submaximal contrations surface EMG activity of upper trapezius (amplitude, RMS)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 7submaximal contractions EMG activity will be expressed as a percentage of maximal reference contractions of the upper trapezius (% reference contractions).2 hours after treatment
Changes in submaximal contrations surface EMG activity of upper trapezius (Median frequency, MF)
Time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
Change in Pain Pressure Threshold (PPT)
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 21 Feb 2021.
- 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
University of Castilla-La Mancha
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 21 Feb 2021. 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?
Changes in resting surface EMG activity (amplitude, RMS) (time frame: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment). 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 21 Feb 2021.