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Completed

NCT Number: NCT03345238

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

universidad de Alcalá de Henares

Alcalá de Henares, Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Tensile band palpable.
  • Exquisite local pain at the pressure of a taut band node.
  • Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
  • 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.

Treatment and study plan

Deep dry needling

Procedure

Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.

Primary outcomes

  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, 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

    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 outcomes

  1. Threshold of pain to pressure

    Time frame: Baseline and immediately after intervention

    Using a Digital algometer in the pain points of the patient.

  2. Cervical pain and dysfunction

    Time frame: Baseline, 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

    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, 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, during intervention and after intervention (1 and 10 minutes after intervention)

    Checking heart rate measuring the beats per minute.

  6. Changes related to the Autonomic Nervous System

    Time frame: Baseline, during intervention and after intervention (1 and 10 minutes after 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, during intervention and after intervention (1 and 10 minutes after intervention)

    Checking changes on skin conductance measuring the conductance of the skin in microsiemens.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Collaborators

  • Luis Martín Sacristán

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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