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Neurophysiological Effects of Dry Needling in Patients With Neck Pain

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Deep Dry Needling
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Dry Needling, Myofascial Pain Syndrome, Neurophysiological effects, Autonomic Nervous System

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • universidad de Alcalá de Henares

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Active MTP

Latent MTP

Out of MTP

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Threshold of pain to pressure
Using a Digital algometer in the pain points of the patient.
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.
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.
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.
Changes related to the Autonomic Nervous System
Checking heart rate measuring the beats per minute.
Changes related to the Autonomic Nervous System
Checking changes of the skin temperature measuring the surface temperature of the skin in ºC.
Changes related to the Autonomic Nervous System
Checking changes on skin conductance measuring the conductance of the skin in microsiemens.

Full Information

First Posted
August 31, 2017
Last Updated
November 6, 2019
Sponsor
Universidad Rey Juan Carlos
Collaborators
Luis Martín Sacristán
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1. Study Identification

Unique Protocol Identification Number
NCT03345238
Brief Title
Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Official Title
Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Luis Martín Sacristán

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Dry Needling, Myofascial Pain Syndrome, Neurophysiological effects, Autonomic Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized controlled trial with double-blind
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active MTP
Arm Type
Experimental
Arm Title
Latent MTP
Arm Type
Experimental
Arm Title
Out of MTP
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Deep Dry Needling
Intervention Description
Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
Primary Outcome Measure Information:
Title
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.
Description
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.
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
Secondary Outcome Measure Information:
Title
Threshold of pain to pressure
Description
Using a Digital algometer in the pain points of the patient.
Time Frame
Baseline and immediately after intervention
Title
Cervical pain and dysfunction
Description
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.
Time Frame
Baseline, a week after intervention and one month after the intervention
Title
Cervical pain and dysfunction
Description
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.
Time Frame
Baseline
Title
Cervical pain and dysfunction
Description
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.
Time Frame
Baseline, a week after intervention and one month after the intervention
Title
Changes related to the Autonomic Nervous System
Description
Checking heart rate measuring the beats per minute.
Time Frame
Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Title
Changes related to the Autonomic Nervous System
Description
Checking changes of the skin temperature measuring the surface temperature of the skin in ºC.
Time Frame
Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Title
Changes related to the Autonomic Nervous System
Description
Checking changes on skin conductance measuring the conductance of the skin in microsiemens.
Time Frame
Baseline, during intervention and after intervention (1 and 10 minutes after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Martín Sacristán, MSc
Organizational Affiliation
University of Alcala
Official's Role
Principal Investigator
Facility Information:
Facility Name
universidad de Alcalá de Henares
City
Alcalá de Henares
State/Province
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurophysiological Effects of Dry Needling in Patients With Neck Pain

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