NCT04684784

Brief 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. Two groups with LTrP in the upper trapezius, and the DN group or the Sham-Dn group will be randomly selected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

December 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2021

Completed
Last Updated

February 21, 2021

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

December 21, 2020

Last Update Submit

February 18, 2021

Conditions

Trigger Point Pain, Myofascial

Keywords

Dry needlingElectromyographyLatent trigger point

Outcome Measures

Primary Outcomes (1)

  • 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).

    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)

    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)

    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)

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

  • Change in Pain Pressure Threshold (PPT)

    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

PLACEBO COMPARATOR

Control-Dry Needling: Sham Dry Needling into the latent trigger point of the upper trapezius muscle

Device: Control-Dry Needling

Interventions

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.

Deep Dry Needling
Control-Dry NeedlingDEVICE

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 onthe 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

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Javier Abián-Vicén, PhD

    University of Castilla-La Mancha

    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

December 21, 2020

First Posted

December 28, 2020

Study Start

January 4, 2021

Primary Completion

February 4, 2021

Study Completion

February 18, 2021

Last Updated

February 21, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)