search
Back to results

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

Primary Purpose

Myofascial Pain Syndrome, Neck Pain, Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling
Sham Dry Needling
Sponsored by
Camilo Jose Cela University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Francisco de Vitoria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry Needling

Sham Dry Needling

Arm Description

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

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.

Outcomes

Primary Outcome Measures

SWE - Young modulus
KPa
SWE - Young modulus
KPa
SWE - Local shear wave speed
m/s
SWE - Local shear wave speed
m/s
Pain Pressure Thresholds
kg/cm2
Pain Pressure Thresholds
kg/cm2

Secondary Outcome Measures

Visual Analogue Scale
0-10
Neck Disability Index
0-100

Full Information

First Posted
March 30, 2021
Last Updated
February 20, 2022
Sponsor
Camilo Jose Cela University
search

1. Study Identification

Unique Protocol Identification Number
NCT04832074
Brief Title
Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling
Acronym
ELECTROP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camilo Jose Cela University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Neck Pain, Trigger Point Pain, Myofascial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blinded, Placebo-Controlled Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
Real Dry Needling in the most active Myofascial Trigger Point
Intervention Type
Other
Intervention Name(s)
Sham Dry Needling
Intervention Description
Sham Dry Needling in the same location, but not piercing the skin
Primary Outcome Measure Information:
Title
SWE - Young modulus
Description
KPa
Time Frame
Baseline
Title
SWE - Young modulus
Description
KPa
Time Frame
10 minutes
Title
SWE - Local shear wave speed
Description
m/s
Time Frame
Baseline
Title
SWE - Local shear wave speed
Description
m/s
Time Frame
10 minutes
Title
Pain Pressure Thresholds
Description
kg/cm2
Time Frame
Baseline
Title
Pain Pressure Thresholds
Description
kg/cm2
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
0-10
Time Frame
Baseline
Title
Neck Disability Index
Description
0-100
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Antonio Valera-Calero, PhD
Organizational Affiliation
Camilo José Cela University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Francisco de Vitoria University
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35765779
Citation
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.
Results Reference
derived

Learn more about this trial

Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling

We'll reach out to this number within 24 hrs