Neurophysiological Effects of Dry Needling in Patients With Neck Pain

The present study aims to evaluate the differences that may be experienced in pain and cervical disability, before, during and just after the intervention of the Deep Dry Needling in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP in Patients with neck pain, assessing, in turn, the neurophysiological effects on the Autonomic Nervous System.

Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease of pain and cervical disability index and increase of pressure pain threshold; Than the Deep Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in patients with chronic neck pain.

Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in patients with chronic neck pain attributable to Myofascial Pain Syndrome.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Procedure: Deep Dry Needling

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain
      • Universidad de Alcalá De Henares

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:

• Non-specific neck pain, unilateral or bilateral.
• Neck pain ≥ 3 months of duration.
• Presence of active and latent MTP in the upper, left, right or bilateral trapezius muscle, in relation to the patient's neck pain.

• Clinical criteria recommended to identify active and latent MTP:

  1. Tensile band palpable.
  2. Exquisite local pain at the pressure of a taut band node.
  3. Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
  4. Painful limitation of range of mobility to complete stretching. It is considered positive when 3 of the 4 clinical criteria are found.

Exclusion Criteria:

• Unsurpassed fear of needles.
• Coagulation disorders.
• Specific alterations of the cervical region in the clinical history.
• Infiltration of corticosteroids or local anesthetics during a year before the study.
• Surgical intervention of the cervical region or previous shoulder.
• Skin lesions in the area, as well as infection or inflammation.
• Taking analgesic, anti-inflammatory or anticoagulant medication the week before the study.
• Treatment of MTP or Deep Dry Needling in the neck region in the 6 months prior to the intervention.
• Cognitive deficit in the medical history.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active MTP	Procedure: Deep Dry Needling; Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
Experimental: Latent MTP	Procedure: Deep Dry Needling; Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
Experimental: Out of MTP	Procedure: Deep Dry Needling; Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Deep Dry Needling applied on Active Myofascial Trigger Points (MTP) vs. latent MTP versus outside MTP, on pain reduction in patients with chronic neck pain.	Checkin the Intensity of pain with the Visual Analogic Scale. It is a 100 mm line that measures the intensity of pain.The left end of the line represents the absence of pain, while the far right represents the worst pain imaginable. The numerical scale of intensity of pain adds a numerical ranking where 1 is no pain and 10 the worst pain imaginable.	Baseline, during intervention, immediately after intervention, 1, 6, 12, 24, 48 and 72 hours after intervention, a week after intervention and one month after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Threshold of pain to pressure	Using a Digital algometer in the pain points of the patient.	Baseline and immediately after intervention
Cervical pain and dysfunction	Using the questionnaire: Neck Disability Index It is the scale that has been used in more different populations and the one that has been more times validated against multiple measures of function, pain and clinical signs and symptoms. The NDI is a self-completed questionnaire with 10 sections. Each of the sections (cervical pain intensity, personal care, weight lifting, reading, headache, ability to concentrate, work capacity, driving, sleep and leisure activities) offers 6 possible answers that represent 6 levels progressive functional capacity, and scored from 0 to 5 (0 = no disability, 5 = total disability). The total score is expressed in percentage terms with respect to the maximum possible.	Baseline, a week after intervention and one month after the intervention
Cervical pain and dysfunction	Using the questionnaire: Catastrophic Scale of Pain It is a self-administered scale of 13 items and one of the most used to assess the construct "catastrophization in the face of pain". It comprises 3 dimensions: a) rumination; b) magnification, and c) hopelessness. The theoretical range of the instrument is between 13 and 62, indicating low scores, little catastrophization, and high values, high catastrophization.	Baseline
Cervical pain and dysfunction	Using the questionnaire: Chronic pain gradation scale It is a scale that serves as a valid, reliable and useful instrument to measure chronic pain early in clinical practice. The first factor formed by 4 items, can be called "disability related to pain"; the second, "the intensity of pain", is made up of 3 items. The version of the scale in Spanish consists of 8 items and the final score is obtained with the sum of items 2 to 8, which results in a range of 0 to 70.	Baseline, a week after intervention and one month after the intervention
Changes related to the Autonomic Nervous System	Checking heart rate measuring the beats per minute.	Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System	Checking changes of the skin temperature measuring the surface temperature of the skin in ºC.	Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System	Checking changes on skin conductance measuring the conductance of the skin in microsiemens.	Baseline, during intervention and after intervention (1 and 10 minutes after intervention)

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Collaborators: Luis Martín Sacristán
• Investigators: Principal Investigator: Luis Martín Sacristán, MSc, University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): August 10, 2019

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Dry Needling; Neurophysiological effects; Myofascial Pain Syndrome
• 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: 31/8/2017

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