Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain

Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Pain
• Intervention / Treatment: Other: Dry Needling; Other: Stretch

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Müller-Thyssen Uriarte; Phone Number: +34 0633673021; Email: julianmuller.jmt@gmail.com

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Centro Clínico de Fisioterapia OMT-E
    • Contact: Jesús Marcen
    • Contact: Phone Number: +34644161870; Email: info@centroclinicoomt.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be older than 18 years old
• Sign informed consent form prior to participating in this study
• Have chronic cervical pain diagnosis of their primary care doctor.
• Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al.

Exclusion Criteria:

• Major trauma on cervical spine stated from the medical history
• Inflammatory, hormonal or neurological disorders
• Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia)
• Having received physiotherapy treatment for the condition in the past month

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling Group	Other: Dry Needling; 3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles.
Active Comparator: Stretch Group	Other: Stretch; 3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Pain Intensity	For the Assesment of cervical pain intensity the Numeric Pain Rating Scale (NPRS) was used.	Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Neck Disability Index	For the assesment of perceived neck disability the neck disability index was used.	Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Pressure Pain Threshold	For the assesment of pressure pain threshold of active trigger points a digital algometer was used	Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical range of movement	For the assesment of cervical range of movement the universal goniometer was used	Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months
Cervical muscles Electromyography	For the assesment of cervical muscles electromyographic activity Trigno Avanti sensor was used.	Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Publications and helpful links

General Publications

• Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.
• Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002.
• Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Fernandez-de-Las-Penas C, Martin-Casas P, Plaza-Manzano G. Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Pain Med. 2022 Mar 2;23(3):515-525. doi: 10.1093/pm/pnab188.
• Ball AM, Finnegan M, Koppenhaver S, Freres W, Dommerholt J, Mayoral Del Moral O, Bron C, Moore R, Ball EE, Gaffney EE. The relative risk to the femoral nerve as a function of patient positioning: potential implications for trigger point dry needling of the iliacus muscle. J Man Manip Ther. 2019 Jul;27(3):162-171. doi: 10.1080/10669817.2019.1568699. Epub 2019 Feb 20.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: RAT 2022-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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