Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling (ELECTROP)

Immediate Stiffness Changes in Upper Trapezius Active Myofascial Trigger Points After Dry Needling in Patients With Neck Pain: A Randomized, Double-Blinded, Placebo-Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Myofascial Pain Syndrome; Trigger Point Pain, Myofascial
• Intervention / Treatment: Other: Dry Needling; Other: Sham Dry Needling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo De Alarcón, Madrid, Spain, 28223
      • Francisco de Vitoria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling; 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; Real Dry Needling in the most active Myofascial Trigger Point
Sham Comparator: Sham Dry Needling; 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; Sham Dry Needling in the same location, but not piercing the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	0-10	Baseline
Neck Disability Index	0-100	Baseline

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Investigators: Principal Investigator: Juan Antonio Valera-Calero, PhD, Camilo Jose Cela University

Publications and helpful links

General Publications

• 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. 2022 Jun 28:9645284221104831. doi: 10.1177/09645284221104831. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 19, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Neck Pain; Myofascial Pain Syndromes
• Other Study ID Numbers: CamiloJcU21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No