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Neurophysiological Effects of Dry Needling in Patients With Neck Pain

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ClinicalTrials.gov Identifier: NCT03345238
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Luis Martín Sacristán
Information provided by (Responsible Party):
Josue Fernandez Carnero, Universidad Rey Juan Carlos

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Procedure: Deep Dry Needling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomized controlled trial with double-blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]

    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.



Secondary Outcome Measures :
  1. Threshold of pain to pressure [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]
    Using a Digital algometer in the pain points of the patient.

  2. Cervical pain and dysfunction [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]

    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.


  3. Cervical pain and dysfunction [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]

    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.


  4. Cervical pain and dysfunction [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]

    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.


  5. Changes related to the Autonomic Nervous System [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]
    Checking heart rate measuring the beats per minute.

  6. Changes related to the Autonomic Nervous System [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]
    Checking changes of the skin temperature measuring the surface temperature of the skin in ºC.

  7. Changes related to the Autonomic Nervous System [ Time Frame: Baseline, immediately after intervention, 24 hours after intervention, a week after intervention and one month after the intervention ]
    Checking changes on skin conductance measuring the conductance of the skin in microsiemens.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345238


Contacts
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Contact: Luis Martín Sacristán, MSc +34650785039 luis.marsac@gmail.com

Locations
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Spain
universidad de Alcalá de Henares Recruiting
Alcalá de Henares, Madrid, Spain
Contact: Luis Martín Sacristán, MSc    +34650785039    luis.marsac@gmail.com   
Sponsors and Collaborators
Universidad Rey Juan Carlos
Luis Martín Sacristán
Investigators
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Principal Investigator: Luis Martín Sacristán, MSc Universidad de Alcalá de Henares

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Responsible Party: Josue Fernandez Carnero, Tesis Director, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT03345238     History of Changes
Other Study ID Numbers: 31/8/2017
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josue Fernandez Carnero, Universidad Rey Juan Carlos:
Dry Needling
Myofascial Pain Syndrome
Neurophysiological effects
Autonomic Nervous System
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases