NCT04832074

Brief Summary

Shear-wave elastography (SWE) is considered as a useful tool for quantifying muscle stiffness. Considering that Myofascial Trigger Points (MTrP) are defined as "hyperirritable zones in contracted bands of muscle, thought to be caused by muscle overload or stress" and the effectiveness of dry needling applied to active MTrP for reducing pain and disability, the aim of this study is to assess the effects of sham and real dry needling, applied to active MTrP in the upper trapezius muscle in patients with chronic neck pain, on the muscle stiffness in two areas: 1) the most symptomatic area and 2) a control point.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

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

March 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
Last Updated

February 22, 2022

Status Verified

May 1, 2021

Enrollment Period

13 days

First QC Date

March 30, 2021

Last Update Submit

February 20, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • SWE - Young modulus

    KPa

    Baseline

  • SWE - Young modulus

    KPa

    10 minutes

  • SWE - Local shear wave speed

    m/s

    Baseline

  • SWE - Local shear wave speed

    m/s

    10 minutes

  • Pain Pressure Thresholds

    kg/cm2

    Baseline

  • Pain Pressure Thresholds

    kg/cm2

    10 minutes

Secondary Outcomes (2)

  • Visual Analogue Scale

    Baseline

  • Neck Disability Index

    Baseline

Study Arms (2)

Dry Needling

EXPERIMENTAL

Dry needling will be performed with 'solid filiform needles'. The procedure is as follows: The participant will lie in the prone position. The overlying skin will be cleaned with antiseptic spray. The taut band and MTrP, will be localized manually. After measuring the Pain Pressure Thresholds in this location and the control (located 3 cm lateral to the MTrP), the needle within its plastic guide tube will be placed over the MTrP. After a tapping movement to insert the needle, the needle will be moved to the muscle around the bundle and moved forward and backward to the tissue to elicit a small muscle twitch. After eliciting LTR, needling will be stopped. If no twitch were elicited, needling will stopped after two or three stellate movements

Other: Dry Needling

Sham Dry Needling

SHAM COMPARATOR

The same approach will be used with the exception of piercing the skin. The guide tube will press against the tissue and the sham needle will be allowed to drop against the skin. The handle will be tapped briskly but not breaking the skin. The sham needle will stay within the guide tube and will be pressed against the skin twice so as to mimic the quick "in and out" technique.

Other: Sham Dry Needling

Interventions

Real Dry Needling in the most active Myofascial Trigger Point

Dry Needling

Sham Dry Needling in the same location, but not piercing the skin

Sham Dry Needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 65 and
  • Presence of mechanical neck pain for at least three months duration
  • Presence of at least one active MTrP in the Upper Trapezius muscle

You may not qualify if:

  • Neck pain of traumatic origin (such as whiplash-associated disorder)
  • Current use of any kind of analgesic therapy
  • Presenting any condition usually considered a perpetuating factor of MTrPs, such as fibromyalgia, hypothyroidism, or iron deficiencies
  • Presenting any contraindication for Dry Needling application
  • Neuropathies (e.g., radiculopathy)
  • Bilateral Pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco de Vitoria University

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Related Publications (1)

  • Valera-Calero JA, Sanchez-Jorge S, Buffet-Garcia J, Varol U, Fernandez-de-Las-Penas C, Alvarez-Gonzalez J. Changes in stiffness at active myofascial trigger points of the upper trapezius after dry needling in patients with chronic neck pain: a randomized controlled trial. Acupunct Med. 2023 Jun;41(3):121-129. doi: 10.1177/09645284221104831. Epub 2022 Jun 28.

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Juan Antonio Valera-Calero, PhD

    Camilo José Cela University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blinded, Placebo-Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 5, 2021

Study Start

May 5, 2021

Primary Completion

May 18, 2021

Study Completion

May 19, 2021

Last Updated

February 22, 2022

Record last verified: 2021-05

Locations