Neck PainNCT03719352
Superficial Dry Needling Versus Deep Dry Needling on the Upper Trapezius
A study testing Experimental: Deep dry needling and Experimental: Superficial dry needling in people with Neck Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
This study investigates the effect of two different techniques (deep dry needling and superficial dry needling) on the latent myofascial trigger point in the upper trapezius. Subjects with latent Myofascial trigger point in this location of the muscle will be identified and will be randomly assigned to one out of the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Experimental: Deep dry needling and Experimental: Superficial dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 24 Oct 2018to 8 Nov 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Present the latent Myofascial trigger Point (MTP) 1 in upper trapezius.
- Accept participation in the study (signature of informed consent).
- Be in an age range between 18 and 55 years.
- Do not present any exclusion criteria.
Who cannot join
- Do not present MTP 1 latent in the upper trapezius.
- Suffering and / or having suffered from upper limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics of the shoulder and neck.
- Not clearly identify the MTP 1 in the upper trapezius.
- Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
- Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
- Having suffered a whiplash.
Show all 12Show fewer
- Be pregnant.
- Have used analgesics 24 hours before participating in the study.
- Having belonephobia.
- Know the study techniques.
- Be in physiotherapy treatment and / or have been treated with needle techniques at some time.
- Having had cervical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis, Comparison and Evaluation of Cervical Range of Motion and Neck Pain After Deep Dry Needling and Superficial Dry Needling in the Upper Trapezius: A Randomised Controlled Trial
This study investigates the effect of two different techniques (deep dry needling and superficial dry needling) on the latent myofascial trigger point in the upper trapezius. Subjects with latent Myofascial trigger point in this location of the muscle will be identified and will be randomly assigned to one out of the three groups: deep dry needling, superficial dry needling or sham dry needling in gastrocnemius muscle. cervical range of motion and pain pressure threshold in the upper trapezius will be registered before, immediately after the intervention, at 24 hours after the intervention, at 72 hours after the intervention and a week after the intervention
- Conditions
- Neck Pain
- Being tested
- Experimental: Deep dry needling, Experimental: Superficial dry needling, Placebo Comparator: Placebo Gastrocnemius dry needling
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Deep dry needlingProcedure or surgery
Deep dry needling until achieving twitch response of the muscle
Experimental: Superficial dry needlingProcedure or surgery
Superficial dry needling to achieve sensitive pain with needle rotation
Placebo Comparator: Placebo Gastrocnemius dry needlingProcedure or surgery
Simulate pain with de plastic needle guard in the gastrocnemius muscle
| Study group | Role | What they receive |
|---|---|---|
| Deep dry needling | Experimental | Deep dry needling will be applied in the upper trapezius myofascial trigger point Receives: Procedure: Experimental: Deep dry needling |
| Superficial dry needling | Experimental | Superficial dry needling will be applied in the upper trapezius myofascial trigger point Receives: Procedure: Experimental: Superficial dry needling |
| Placebo Gastrocnemius dry needling | Placebo comparator | A technique simulating dry needling will be applied in the gastrocnemius myofascial trigger point with a needle guard guide tube, without any therapeutic manoeuvre will be applied. Receives: Procedure: Placebo Comparator: Placebo Gastrocnemius dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Amount of pressure (Kg/cm2) applied at the upper trapezius myofascial trigger point site that elicit pain for the patient will be reported
Measured: a week
Secondary outcomes (1)
Cervical range of motion
cervical movement in flexion and extension, left and right rotation and side bending left and right
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start24 Oct 2018
- Primary completion25 Oct 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- Sergio Montero-Navarro, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719352
- Sponsor's protocol ID
- CEU UCH 205
- Status last verified
- Nov 2018
- First submitted
- 15 Oct 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Segura-Orti E, Prades-Vergara S, Manzaneda-Pina L, Valero-Martinez R, Polo-Traverso JA. Trigger point dry needling versus strain-counterstrain technique for upper trapezius myofascial trigger points: a randomised controlled trial. Acupunct Med. 2016 Jun;34(3):171-7. doi: 10.1136/acupmed-2015-010868. Epub 2016 Jan 8.
PubMed 26746173Martin-Pintado-Zugasti A, Pecos-Martin D, Rodriguez-Fernandez AL, Alguacil-Diego IM, Portillo-Aceituno A, Gallego-Izquierdo T, Fernandez-Carnero J. Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Postneedling Soreness Intensity and Duration. PM R. 2015 Oct;7(10):1026-1034. doi: 10.1016/j.pmrj.2015.03.021. Epub 2015 Mar 31.
PubMed 25836591Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
PubMed 24725800Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.
PubMed 24568260Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
PubMed 25269764Abbaszadeh-Amirdehi M, Ansari NN, Naghdi S, Olyaei G, Nourbakhsh MR. Therapeutic effects of dry needling in patients with upper trapezius myofascial trigger points. Acupunct Med. 2017 Apr;35(2):85-92. doi: 10.1136/acupmed-2016-011082. Epub 2016 Oct 3.
PubMed 27697768Montero Navarro S, Del Rio Medina S, Martin Botella Rico J, Isabel Rocha Ortiz M, Teresa Perez Gracia M. Analysis and comparison of pain pressure threshold and active cervical range of motion after superficial and deep dry needling techniques of the upper trapezius muscle. Acupunct Med. 2022 Feb;40(1):13-23. doi: 10.1177/09645284211039523. Epub 2021 Sep 23.
PubMed 34553614
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis, Comparison and Evaluation of Cervical Range of Motion and Neck Pain After Deep Dry Needling and Superficial Dry Needling in the Upper Trapezius: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03719352
- Acronym / sponsor ID
- CEU UCH 205
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 25 Oct 2018 (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.
This study investigates the effect of two different techniques (deep dry needling and superficial dry needling) on the latent myofascial trigger point in the upper trapezius. Subjects with latent Myofascial trigger point in this location of the muscle will be identified and will be randomly assigned to one out of the three groups: deep dry needling, superficial dry needling or sham dry needling in gastrocnemius muscle. cervical range of motion and pain pressure threshold in the upper trapezius will be registered before, immediately after the intervention, at 24 hours after the intervention, at 72 hours after the intervention and a week after the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep dry needling | Experimental | Procedure: Experimental: Deep dry needlingDeep dry needling will be applied in the upper trapezius myofascial trigger point |
| Superficial dry needling | Experimental | Procedure: Experimental: Superficial dry needlingSuperficial dry needling will be applied in the upper trapezius myofascial trigger point |
| Placebo Gastrocnemius dry needling | Placebo comparator | Procedure: Placebo Comparator: Placebo Gastrocnemius dry needlingA technique simulating dry needling will be applied in the gastrocnemius myofascial trigger point with a needle guard guide tube, without any therapeutic manoeuvre will be applied. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Present the latent Myofascial trigger Point (MTP) 1 in upper trapezius.
- Accept participation in the study (signature of informed consent).
- Be in an age range between 18 and 55 years.
- Do not present any exclusion criteria.
Key exclusion criteria (12 listed)
- Do not present MTP 1 latent in the upper trapezius.
- Suffering and / or having suffered from upper limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics of the shoulder and neck.
- Not clearly identify the MTP 1 in the upper trapezius.
- Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
- Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
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 |
|---|---|---|
| Experimental: Deep dry needlingDeep dry needling until achieving twitch response of the muscle | Procedure or surgery | Deep dry needling |
| Experimental: Superficial dry needlingSuperficial dry needling to achieve sensitive pain with needle rotation | Procedure or surgery | Superficial dry needling |
| Placebo Comparator: Placebo Gastrocnemius dry needlingSimulate pain with de plastic needle guard in the gastrocnemius muscle | Procedure or surgery | Placebo Gastrocnemius dry needling |
Primary outcome
Pain pressure threshold
Time frame: a week
Amount of pressure (Kg/cm2) applied at the upper trapezius myofascial trigger point site that elicit pain for the patient will be reported
1 secondary outcome
Cervical range of motion
Time frame: a week
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 14 Nov 2018.
- Background: PubMed 26746173Segura-Orti E, Prades-Vergara S, Manzaneda-Pina L, Valero-Martinez R, Polo-Traverso JA. Trigger point dry needling versus strain-counterstrain technique for upper trapezius myofascial trigger points: a randomised controlled trial. Acupunct Med. 2016 Jun;34(3):171-7. doi: 10.1136/acupmed-2015-010868. Epub 2016 Jan 8.
- Background: PubMed 25836591Martin-Pintado-Zugasti A, Pecos-Martin D, Rodriguez-Fernandez AL, Alguacil-Diego IM, Portillo-Aceituno A, Gallego-Izquierdo T, Fernandez-Carnero J. Ischemic Compression After Dry Needling of a Latent Myofascial Trigger Point Reduces Postneedling Soreness Intensity and Duration. PM R. 2015 Oct;7(10):1026-1034. doi: 10.1016/j.pmrj.2015.03.021. Epub 2015 Mar 31.
- Background: PubMed 24725800Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
- Background: PubMed 24568260Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.
- Background: PubMed 25269764Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
- Results publication: PubMed 27697768Abbaszadeh-Amirdehi M, Ansari NN, Naghdi S, Olyaei G, Nourbakhsh MR. Therapeutic effects of dry needling in patients with upper trapezius myofascial trigger points. Acupunct Med. 2017 Apr;35(2):85-92. doi: 10.1136/acupmed-2016-011082. Epub 2016 Oct 3.
- Derived from this study: PubMed 34553614Montero Navarro S, Del Rio Medina S, Martin Botella Rico J, Isabel Rocha Ortiz M, Teresa Perez Gracia M. Analysis and comparison of pain pressure threshold and active cervical range of motion after superficial and deep dry needling techniques of the upper trapezius muscle. Acupunct Med. 2022 Feb;40(1):13-23. doi: 10.1177/09645284211039523. Epub 2021 Sep 23.
- The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over SpainLink provided by the sponsor.
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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.
Sergio Montero-Navarro, PhD principal investigator
Cardenal Herrera 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 Experimental: Deep dry needling and Experimental: Superficial dry needling in people with Neck Pain, run by Cardenal Herrera University 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 12 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 14 Nov 2018. 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?
Pain pressure threshold (time frame: a week). 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 NCT03719352, which also lists 7 linked publications.
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 14 Nov 2018.