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

• ClinicalTrials.gov Identifier: NCT04832074
• Recruitment Status: Completed
• First Posted: April 5, 2021
• Last Update Posted: February 22, 2022
• Sponsor: Camilo Jose Cela University
• Information provided by (Responsible Party): Camilo Jose Cela University

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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain Syndrome; Neck Pain; Trigger Point Pain, Myofascial	Other: Dry Needling; Other: Sham Dry Needling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-Blinded, Placebo-Controlled Trial
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 5, 2021
• Actual Primary Completion Date: May 18, 2021
• Actual Study Completion Date: May 19, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. SWE - Young modulus [ Time Frame: Baseline ]
   KPa
2. SWE - Young modulus [ Time Frame: 10 minutes ]
   KPa
3. SWE - Local shear wave speed [ Time Frame: Baseline ]
   m/s
4. SWE - Local shear wave speed [ Time Frame: 10 minutes ]
   m/s
5. Pain Pressure Thresholds [ Time Frame: Baseline ]
   kg/cm2
6. Pain Pressure Thresholds [ Time Frame: 10 minutes ]
   kg/cm2

Secondary Outcome Measures :

1. Visual Analogue Scale [ Time Frame: Baseline ]
   0-10
2. Neck Disability Index [ Time Frame: Baseline ]
   0-100

Eligibility Criteria

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

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

Contacts and Locations

Locations

Spain

Francisco de Vitoria University

Pozuelo De Alarcón, Madrid, Spain, 28223

Sponsors and Collaborators

Camilo Jose Cela University

Investigators

• Principal Investigator: Juan Antonio Valera-Calero, PhD; Camilo José Cela University

More Information

• Responsible Party: Camilo Jose Cela University
• ClinicalTrials.gov Identifier: NCT04832074
• Other Study ID Numbers: CamiloJcU21
• First Posted: April 5, 2021
• Last Update Posted: February 22, 2022
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myofascial Pain Syndromes; Fibromyalgia; Neck Pain; Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases