Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurophysiological Effects of Dry Needling in Patients With Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE March 13, 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Official Title  ICMJE Neurophysiological Effects of Dry Needling in Patients With Neck Pain
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Randomized controlled trial with double-blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myofascial Pain Syndrome
Intervention  ICMJE Procedure: Deep Dry Needling
Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
Study Arms  ICMJE
  • Experimental: Active MTP
    Intervention: Procedure: Deep Dry Needling
  • Experimental: Latent MTP
    Intervention: Procedure: Deep Dry Needling
  • Experimental: Out of MTP
    Intervention: Procedure: Deep Dry Needling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luis Martín Sacristán, MSc +34650785039 luis.marsac@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345238
Other Study ID Numbers  ICMJE 31/8/2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Josue Fernandez Carnero, Universidad Rey Juan Carlos
Study Sponsor  ICMJE Universidad Rey Juan Carlos
Collaborators  ICMJE Luis Martín Sacristán
Investigators  ICMJE
Principal Investigator: Luis Martín Sacristán, MSc Universidad de Alcalá de Henares
PRS Account Universidad Rey Juan Carlos
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP