Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling
ELECTROP
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
1 active site
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
March 30, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
May 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2021
CompletedFebruary 22, 2022
May 1, 2021
13 days
March 30, 2021
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
EXPERIMENTALDry 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
Sham Dry Needling
SHAM COMPARATORThe 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.
Interventions
Sham Dry Needling in the same location, but not piercing the skin
Eligibility Criteria
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
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.
PMID: 35765779DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Antonio Valera-Calero, PhD
Camilo José Cela University
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
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