NCT04394741

Brief Summary

The purpose of this study is to determine whether application of Dry Needling (DN) is effective for reduced on Stiffness in Latent trigger point (LTrP) of upper trapezius. The secondary purposes are to determine the correlation on two elastography for stiffness measure (Shear-wave elastography and Strain elastography). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

May 10, 2020

Last Update Submit

September 30, 2020

Conditions

Keywords

PainLatent trigger pointStiffnessDry Needling

Outcome Measures

Primary Outcomes (1)

  • Change on Stiffness (Shear wave elastography and Strain Elastography)

    Shear-wave Elastography (SWE) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined with measuring velocity of shear waves in trapezius muscle on SWE exam. Strain elastography (SEL) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined by applying light repetitive compression with the hand-held transducer

    Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

Secondary Outcomes (3)

  • Change in Pain Pressure Threshold (PPT)

    Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

  • Change in Thickness of muscle

    Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

  • Change in Post-needling soreness

    Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment

Study Arms (2)

Deep Dry Needling

EXPERIMENTAL

Intervention-Dry Needling: Deep Dry Needing into the latent trigger point of the upper trapezius muscle

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

Device: Intervention-Dry NeedlingDevice: Control-Dry Needling

Interventions

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.

Deep Dry NeedlingSham Dry Needling

Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles 1 session in upper trapezius muscle moving the needle up and down ten times.

Sham Dry Needling

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Performance and Sport Rehabilitation Laboratory

Toledo, 45071, Spain

Location

Related Publications (5)

  • Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.

    PMID: 17996549BACKGROUND
  • Grabowski PJ, Slane LC, Thelen DG, Obermire T, Lee KS. Evidence of Generalized Muscle Stiffness in the Presence of Latent Trigger Points Within Infraspinatus. Arch Phys Med Rehabil. 2018 Nov;99(11):2257-2262. doi: 10.1016/j.apmr.2018.03.024. Epub 2018 Apr 28.

    PMID: 29709524BACKGROUND
  • Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.

    PMID: 23684553BACKGROUND
  • Luan S, Zhu ZM, Ruan JL, Lin CN, Ke SJ, Xin WJ, Liu CC, Wu SL, Ma C. Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points. Am J Phys Med Rehabil. 2019 Aug;98(8):677-684. doi: 10.1097/PHM.0000000000001173.

    PMID: 31318748BACKGROUND
  • Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of Dry Needling on Muscle Stiffness in Latent Myofascial Trigger Points: A Randomized Controlled Trial. J Pain. 2021 Jul;22(7):817-825. doi: 10.1016/j.jpain.2021.02.004. Epub 2021 Feb 23.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Abián-Vicén, PhD

    Castilla-La Mancha University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 19, 2020

Study Start

June 1, 2020

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations