NCT04466813

Brief 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. 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

July 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

October 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 6, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

Latent trigger pointDry needlingMyotonometerTensiomyography

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (9)

  • Change in Oscillation Frequency

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

  • Change in Decrement (elasticity)

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

  • Change in Mechanical Stress Relaxation Time [ms]

    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)

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

  • Change in Contraction time (Tc)

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

  • +4 more secondary outcomes

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: 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 Needling

Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles

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 (1)

  • 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.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

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

July 6, 2020

First Posted

July 10, 2020

Study Start

July 20, 2020

Primary Completion

September 20, 2020

Study Completion

October 20, 2020

Last Updated

October 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations