<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495465</url>
  </required_header>
  <id_info>
    <org_study_id>UJAShockWavesNeck2020</org_study_id>
    <nct_id>NCT04495465</nct_id>
  </id_info>
  <brief_title>Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain</brief_title>
  <official_title>Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jaén</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jaén</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the effects of radial shock wave therapy in neck pain. For&#xD;
      this objective, subjects recruited will be allocated in an experimental group or a placebo&#xD;
      group. Both groups will receive one manual therapy and radial shock waves therapy (real for&#xD;
      experimental group, a sham device for placebo group) session per week along one month. Neck&#xD;
      pain, neck function, temporomandibular pain, temporomandibular function and quality of life&#xD;
      measured will be performed before the intervention, after the last treatment and at one month&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck pain is defined as discomfort or more intense forms of pain that are localized to the&#xD;
      cervical region. The multifactorial etiology of neck pain includes trauma, ergonomic factors&#xD;
      such as inappropriate postures, repetitive movements, strong physical activity, individual&#xD;
      factors such as age, BMI, genetic factors, behavioral factors, and psychosocial factors.&#xD;
&#xD;
      The prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a&#xD;
      short time and the other half will suffer pain for a longer time. There is a higher&#xD;
      prevalence in widows and separated, people with few economic resources, jobs that involve&#xD;
      physical effort, low educational level, anxiety and depression. Furthermore, there is a high&#xD;
      relationship between cervical pain and temporomandibular disorders.&#xD;
&#xD;
      From this study, the investigators are going to carry out a non-invasive, analgesic,&#xD;
      antiinflammatory treatment and without negative side effects for the patient through radial&#xD;
      extracorporeal shock waves (rESWT), and manual therapy (TM). Among the effects produced by&#xD;
      shock waves the investigators find that they improve circulation due to increased blood flow&#xD;
      and oxygenation, at tissue level the permeability of the membrane increases and its metabolic&#xD;
      process, therefore facilitating the activation of tissue regeneration processes experiencing&#xD;
      dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle&#xD;
      relaxation.&#xD;
&#xD;
      The main objective of the study is to evaluate the capacity of the shock waves to improve the&#xD;
      alterations due to neck pain. To meet the above objective, a single-blind randomized clinical&#xD;
      trial study has been designed. The selected subjects will be of legal age diagnosed with neck&#xD;
      pain and those subjects that due to their own characteristics are not able to carry out the&#xD;
      study will be excluded. Subjects will receive a weekly physical therapy session for four&#xD;
      weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of&#xD;
      subjects who will receive manual therapy treatment and shock waves and T2 placebo group in&#xD;
      which the subjects will receive manual therapy and placebo shock waves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">January 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups: experimental group and placebo group, receiving the intervention at the same time</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck pain intensity</measure>
    <time_frame>baseline</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck pain intensity</measure>
    <time_frame>at one month</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck pain intensity</measure>
    <time_frame>at two months</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>baseline</time_frame>
    <description>Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: &quot;no disability&quot; if the result is between 0 and 4, &quot;moderate disability&quot; between 15 and 24, and &quot;complete disability&quot; between 35 and 50.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>at one month</time_frame>
    <description>Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: &quot;no disability&quot; if the result is between 0 and 4, &quot;moderate disability&quot; between 15 and 24, and &quot;complete disability&quot; between 35 and 50</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck function</measure>
    <time_frame>at two months</time_frame>
    <description>Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: &quot;no disability&quot; if the result is between 0 and 4, &quot;moderate disability&quot; between 15 and 24, and &quot;complete disability&quot; between 35 and 50</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>temporomandibular pain intensity</measure>
    <time_frame>baseline</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>temporomandibular pain intensity</measure>
    <time_frame>at one month</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>temporomandibular pain intensity</measure>
    <time_frame>at two months</time_frame>
    <description>Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>baseline</time_frame>
    <description>using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>at one month</time_frame>
    <description>using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular joint function</measure>
    <time_frame>at two months</time_frame>
    <description>using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of life</measure>
    <time_frame>baseline</time_frame>
    <description>12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of life</measure>
    <time_frame>at one month</time_frame>
    <description>12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of life</measure>
    <time_frame>at two months</time_frame>
    <description>12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life.</measure>
    <time_frame>baseline</time_frame>
    <description>The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are &quot;never&quot;, &quot;rarely&quot;, &quot;sometimes&quot;, &quot;very often&quot; and &quot;always&quot;. The numerical result is the sum of the answers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life</measure>
    <time_frame>at one month</time_frame>
    <description>The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are &quot;never&quot;, &quot;rarely&quot;, &quot;sometimes&quot;, &quot;very often&quot; and &quot;always&quot;. The numerical result is the sum of the answers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache impact in quality of life</measure>
    <time_frame>at two months</time_frame>
    <description>The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are &quot;never&quot;, &quot;rarely&quot;, &quot;sometimes&quot;, &quot;very often&quot; and &quot;always&quot;. The numerical result is the sum of the answers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>baseline</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>at one month</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>at two months</time_frame>
    <description>Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>weight</measure>
    <time_frame>baseline</time_frame>
    <description>Record of information provided by the patient about sex, age, weight, height and body weight in kilograms (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>height</measure>
    <time_frame>baseline</time_frame>
    <description>height in meters (m)</description>
  </other_outcome>
  <other_outcome>
    <measure>body mass index</measure>
    <time_frame>baseline</time_frame>
    <description>weight and height will be combined to report body mass index in kg / m ^ 2</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Neck Pain</condition>
  <condition>Musculoskeletal Manipulations</condition>
  <condition>Extracorporeal Shockwave Therapy</condition>
  <arm_group>
    <arm_group_label>Experimental group: manual therapy + shock waves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of extracorporeal radial shock waves therapy on painful points of neck muscles at 2 bars and 10 Hetzs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: manual therapy + placebo shock waves</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radial Shock Wave Therapy</intervention_name>
    <description>2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs</description>
    <arm_group_label>Experimental group: manual therapy + shock waves</arm_group_label>
    <other_name>Extracorporeal Shockwave Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>25 minute massage to neck muscles</description>
    <arm_group_label>Control group: manual therapy + placebo shock waves</arm_group_label>
    <arm_group_label>Experimental group: manual therapy + shock waves</arm_group_label>
    <other_name>Musculoskeletal Manipulations</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo shock waves</intervention_name>
    <description>3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.</description>
    <arm_group_label>Control group: manual therapy + placebo shock waves</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed of neck pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who due to their own characteristics are not able to carry out the study&#xD;
             tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafael Lomas-Vega, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jaén</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Fisiomedic</name>
      <address>
        <city>Dos Hermanas</city>
        <state>Sevilla</state>
        <zip>41701</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jaén</investigator_affiliation>
    <investigator_full_name>NOELIA ZAGALAZ ANULA</investigator_full_name>
    <investigator_title>Health Sciences Department Professor</investigator_title>
  </responsible_party>
  <keyword>Neck Pain</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <keyword>Extracorporeal Shockwave Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495465
org study id: UJAShockWavesNeck2020
nct id: NCT04495465
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the effects of radial shock wave therapy in neck pain. For
      this objective, subjects recruited will be allocated in an experimental group or a placebo
      group. Both groups will receive one manual therapy and radial shock waves therapy (real for
      experimental group, a sham device for placebo group) session per week along one month. Neck
      pain, neck function, temporomandibular pain, temporomandibular function and quality of life
      measured will be performed before the intervention, after the last treatment and at one month
      follow-up.
Neck pain is defined as discomfort or more intense forms of pain that are localized to the
      cervical region. The multifactorial etiology of neck pain includes trauma, ergonomic factors
      such as inappropriate postures, repetitive movements, strong physical activity, individual
      factors such as age, BMI, genetic factors, behavioral factors, and psychosocial factors.

      The prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a
      short time and the other half will suffer pain for a longer time. There is a higher
      prevalence in widows and separated, people with few economic resources, jobs that involve
      physical effort, low educational level, anxiety and depression. Furthermore, there is a high
      relationship between cervical pain and temporomandibular disorders.

      From this study, the investigators are going to carry out a non-invasive, analgesic,
      antiinflammatory treatment and without negative side effects for the patient through radial
      extracorporeal shock waves (rESWT), and manual therapy (TM). Among the effects produced by
      shock waves the investigators find that they improve circulation due to increased blood flow
      and oxygenation, at tissue level the permeability of the membrane increases and its metabolic
      process, therefore facilitating the activation of tissue regeneration processes experiencing
      dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle
      relaxation.

      The main objective of the study is to evaluate the capacity of the shock waves to improve the
      alterations due to neck pain. To meet the above objective, a single-blind randomized clinical
      trial study has been designed. The selected subjects will be of legal age diagnosed with neck
      pain and those subjects that due to their own characteristics are not able to carry out the
      study will be excluded. Subjects will receive a weekly physical therapy session for four
      weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of
      subjects who will receive manual therapy treatment and shock waves and T2 placebo group in
      which the subjects will receive manual therapy and placebo shock waves.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups: experimental group and placebo group, receiving the intervention at the same time
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Neck pain intensity
time frame: baseline
description: Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: Neck pain intensity
time frame: at one month
description: Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: Neck pain intensity
time frame: at two months
description: Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: Neck function
time frame: baseline
description: Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50.
measure: Neck function
time frame: at one month
description: Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
measure: Neck function
time frame: at two months
description: Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
measure: temporomandibular pain intensity
time frame: baseline
description: Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: temporomandibular pain intensity
time frame: at one month
description: Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: temporomandibular pain intensity
time frame: at two months
description: Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
measure: Temporomandibular joint function
time frame: baseline
description: using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
measure: Temporomandibular joint function
time frame: at one month
description: using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
measure: Temporomandibular joint function
time frame: at two months
description: using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
measure: Health Related Quality of life
time frame: baseline
description: 12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
measure: Health Related Quality of life
time frame: at one month
description: 12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
measure: Health Related Quality of life
time frame: at two months
description: 12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
measure: Headache impact in quality of life.
time frame: baseline
description: The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
measure: Headache impact in quality of life
time frame: at one month
description: The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
measure: Headache impact in quality of life
time frame: at two months
description: The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
measure: Dizziness
time frame: baseline
description: Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
measure: Dizziness
time frame: at one month
description: Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
measure: Dizziness
time frame: at two months
description: Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
measure: weight
time frame: baseline
description: Record of information provided by the patient about sex, age, weight, height and body weight in kilograms (kg)
measure: height
time frame: baseline
description: height in meters (m)
measure: body mass index
time frame: baseline
description: weight and height will be combined to report body mass index in kg / m ^ 2
arm group label: Experimental group: manual therapy + shock waves
arm group type: Experimental
description: Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of extracorporeal radial shock waves therapy on painful points of neck muscles at 2 bars and 10 Hetzs.
arm group label: Control group: manual therapy + placebo shock waves
arm group type: Placebo Comparator
description: Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.
intervention type: Other
intervention name: Radial Shock Wave Therapy
description: 2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs
arm group label: Experimental group: manual therapy + shock waves
other name: Extracorporeal Shockwave Therapy
intervention type: Other
intervention name: Manual Therapy
description: 25 minute massage to neck muscles
arm group label: Control group: manual therapy + placebo shock waves
arm group label: Experimental group: manual therapy + shock waves
other name: Musculoskeletal Manipulations
intervention type: Other
intervention name: placebo shock waves
description: 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.
arm group label: Control group: manual therapy + placebo shock waves
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rafael Lomas-Vega, PhD
role: Principal Investigator
affiliation: University of Jaén
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Jaén
investigator full name: NOELIA ZAGALAZ ANULA
investigator title: Health Sciences Department Professor
mesh term: Neck Pain
sharing ipd: No