NCT03719352

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1 day

First QC Date

October 15, 2018

Last Update Submit

November 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    a week

Secondary Outcomes (1)

  • Cervical range of motion

    a week

Study Arms (3)

Deep dry needling

EXPERIMENTAL

Deep dry needling will be applied in the upper trapezius myofascial trigger point

Procedure: Experimental: Deep dry needling

Superficial dry needling

EXPERIMENTAL

Superficial dry needling will be applied in the upper trapezius myofascial trigger point

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.

Procedure: Placebo Comparator: Placebo Gastrocnemius dry needling

Interventions

Deep dry needling until achieving twitch response of the muscle

Deep dry needling

Superficial dry needling to achieve sensitive pain with needle rotation

Superficial dry needling

Simulate pain with de plastic needle guard in the gastrocnemius muscle

Placebo Gastrocnemius dry needling

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Moncada, 46113, Spain

Location

Related Publications (7)

  • 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.

    PMID: 26746173BACKGROUND
  • Martin-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.

    PMID: 25836591BACKGROUND
  • Ziaeifar 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.

    PMID: 24725800BACKGROUND
  • Mejuto-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.

    PMID: 24568260BACKGROUND
  • Llamas-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.

    PMID: 25269764BACKGROUND
  • Abbaszadeh-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.

  • Montero 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.

Related Links

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sergio Montero-Navarro, PhD

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (participant, outcomes Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 25, 2018

Study Start

October 24, 2018

Primary Completion

October 25, 2018

Study Completion

November 8, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations