xml: <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/NCT05990153</url>
    </required_header>
    <id_info>
      <org_study_id>2023.028</org_study_id>
      <nct_id>NCT05990153</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients With Headache</brief_title>
    <official_title>Evaluation of the Efficacy of Manual Therapy, Therapeutic Exercise and the Two Modalities Combined in Pain Reduction in Patients Suffering From Cervicogenic Headache, or Primary Headache (Tension-type Headache, Migraine, Trigeminal Autonomic Headache)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Campus Bio-Medico University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Campus Bio-Medico University</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 study aims to evaluate which is the best approach for the non-pharmacological treatment&#xD;
        of patients with different types of primary headaches (tension-type headache (TTC),&#xD;
        trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing&#xD;
        three methods of intervention to control treatment (drug therapy): therapeutic exercise (TE),&#xD;
        myofascial release + TE, and Mulligan's manual therapy + TE. The efficacy will be evaluated&#xD;
        in terms of reduction of headache episodes, pain intensity and its duration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be evaluated before the start of treatment (T0), at the end of treatment (T1),&#xD;
        3 months after T1 (T2), 6 months after T1 (T3). Results will be stratified by gender, age&#xD;
        range, and type of headache diagnosed.&#xD;
  &#xD;
        The 3 non-pharmacological treatment groups will carry out 12 treatment sessions, 3 times a&#xD;
        week for 4 weeks, with a duration of 45 minutes each. The control group (CTRL) will carry out&#xD;
        pharmacological treatment according to clinical practice, the patients of the CTRL group at&#xD;
        the end of the last follow-up evaluation (T3 at 6 months) at their request will be randomized&#xD;
        into one of the other three intervention groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 5, 2023</start_date>
    <completion_date type="Anticipated">April 2026</completion_date>
    <primary_completion_date type="Anticipated">February 2025</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>The allocation sequence will occur by 1:1:1:1 randomization, using the Clinical Trial Randomization tool (web https://ctrandomization.cancer.gov/), stratifying by headache type. The allocation of patients will be hidden, through the use of sealed envelopes in which the randomization will be contained. The enrollment will be carried out by the medical doctors of the Headache and Neurosonology Center clinics of the Campus Bio-Medico University Hospital Foundation, who will communicate the patient's name to a third person external to the study who will assign the patient according to the randomization plan developed.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>the assessor is unaware of the type of treatment the patients have received</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Headache frequency</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>number of headache attacks in one month</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Headache frequency</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>number of headache attacks in one month</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Headache frequency</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>number of headache attacks in one month</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Headache clinical presentation</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache clinical presentation</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache clinical presentation</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related disability</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>The headache related disability is assessed through the neck disability index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related Disability</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>The headache related disability is assessed through the neck disability index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related Disability</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>The headache related disability is assessed through the neck disability index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related Disability</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>The headache related disability is assessed through the migraine disability assessment test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related Disability</measure>
      <time_frame>3 months after the end of the treatment;</time_frame>
      <description>The headache related disability is assessed through the migraine disability assessment test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache related Disability</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>The headache related disability is assessed through the migraine disability assessment test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>The quality of life is assessed through the Short Form-36 Health Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>The quality of life is assessed through the Short Form-36 Health Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Quality of life</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>The quality of life is assessed through the Short Form-36 Health Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical Range of Motion</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>Active cervical range of motion recorded through the dynamo vald system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical Range of Motion</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>Active cervical range of motion recorded through the dynamo vald system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical Range of Motion</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>Active cervical range of motion recorded through the dynamo vald system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical muscles Strength</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical muscles Strength</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cervical muscles Strength</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug intake</measure>
      <time_frame>4 weeks (end of treatment)</time_frame>
      <description>Number of drug intake reported in the headache diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug intake</measure>
      <time_frame>3 months after the end of the treatment</time_frame>
      <description>Number of drug intake reported in the headache diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug intake</measure>
      <time_frame>6 months after the end of the treatment</time_frame>
      <description>Number of drug intake reported in the headache diary</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Headache</condition>
    <arm_group>
      <arm_group_label>Myofascial Release (MR) + Therapeutic exercise (TE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the MR+TE group will undergo 12 sessions (3 d/week) of sub-occipital inhibition treatment as a combined muscle and soft tissue inhibition technique. The physiotherapist will apply deep pressure which will be maintained for a total of 10 minutes until the sub-occipital tissues are released. In addition to this technique, the method of pumping and manual treatment (acupressure) of the trigger points on the sub-occipital muscles, on the upper bundles of the trapezius bilaterally, on the sternocleidomastoid bilaterally and on the scalene muscles bilaterally will be applied for a further 10 minutes for a total treatment with myofascial release equal to 20 minutes. At the end of the MR session, the 20-minute TE session will be performed in the same way as described in the TE intervention group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Manual therapy (MT) + Therapeutic exercise (TE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The MT+TE intervention group will carry out rehabilitation treatment with a structured protocol based on mobilizations according to the Mulligan method. Treatment according to Mulligan will be carried out at the discretion of the therapist on the basis of daily evaluations of cervical dysfunction and the eventual manifestation of headache. 5 different techniques will be performed on the patient in 12 sessions (3 v/week, for 4 weeks) as described in Satpute, K., Bedekar, N. &amp; Hall, T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord 22, (2021)..</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Therapeutic exercise (TE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the TE intervention group will be asked to perform 12 sessions (3 day/week) of TE supervised by a physiotherapist. Each session will have a total duration of 40 min divided into 20 min of aerobic exercise and 20 min of TE. Aerobic exercise consists of a total of 20 min of activity on a stationary bike using parameters to increase performance (intensity over 20 min) progressively based on fatigue (Borg scale).The TE consists of warm-up and cool-down exercises for the cervical ROM, associated with stretching exercises of the cervical and scapulothoracic muscles. After the warm-up, muscle strengthening exercises will be performed (isometric, concentric and eccentric contractions of the cervical muscles).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Myofascial Release (MR)</intervention_name>
      <description>Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.</description>
      <arm_group_label>Myofascial Release (MR) + Therapeutic exercise (TE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>clinical practice drug treatment</intervention_name>
      <description>drug treatment according to the medical indications of clinical practice</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manual therapy (MT)</intervention_name>
      <description>The manual therapy consists of the concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Passive end-of-range overpressure, or stretching, is then delivered without pain as a barrier.</description>
      <arm_group_label>Manual therapy (MT) + Therapeutic exercise (TE)</arm_group_label>
      <other_name>Mulligan Concept</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therapeutic exercise (TE)</intervention_name>
      <description>The ET consists of an initial phase of aerobic exercise (cyclette), subsequently the intervention foresees exercises for the cervical ROM, stretching exercises of the cervical and scapulothoracic muscles and muscle strengthening exercises (isometric, concentric and eccentrics of the cervical musculature).</description>
      <arm_group_label>Manual therapy (MT) + Therapeutic exercise (TE)</arm_group_label>
      <arm_group_label>Myofascial Release (MR) + Therapeutic exercise (TE)</arm_group_label>
      <arm_group_label>Therapeutic exercise (TE)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients suffering from primary headache or cervicogenic headache;&#xD;
  &#xD;
            -  Age &gt; 18 years;&#xD;
  &#xD;
            -  signature of the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  upper cervical spine instability;&#xD;
  &#xD;
            -  cervical arterial insufficiency&#xD;
  &#xD;
            -  cervical spine fractures&#xD;
  &#xD;
            -  pregnancies&#xD;
  &#xD;
            -  rheumatoid arthritis&#xD;
  &#xD;
            -  severe cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvia Sterzi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario Campus Bio-Medico</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Silvia Sterzi, MD</last_name>
      <phone>+390622541624</phone>
      <email>s.sterzi@policlinicocampus.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marco Bravi, PT</last_name>
      <phone>+393285357278</phone>
      <email>m.bravi@policlinicocampus.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rehabilitation Department Fondazione Policlinico Universitario Campus Bio-Medico</name>
        <address>
          <city>Roma</city>
          <state>RM</state>
          <zip>00128</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvia Sterzi, MD</last_name>
        <phone>+390622541624</phone>
        <email>s.sterzi@policlinicocampus.it</email>
      </contact>
      <contact_backup>
        <last_name>Marco Bravi, PT</last_name>
        <phone>+393285357278</phone>
        <email>m.bravi@policlinicocampus.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
      <investigator_full_name>Silvia Sterzi</investigator_full_name>
      <investigator_title>Director of Physical Medicine and Rehabilitative Unit</investigator_title>
    </responsible_party>
    <keyword>headache</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>manual therapy</keyword>
    <keyword>exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990153
  org study id: 2023.028
  nct id: NCT05990153
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to evaluate which is the best approach for the non-pharmacological treatment
        of patients with different types of primary headaches (tension-type headache (TTC),
        trigeminal autonomic headache (TACs) and migraine) or cervicogenic headache by comparing
        three methods of intervention to control treatment (drug therapy): therapeutic exercise (TE),
        myofascial release + TE, and Mulligan's manual therapy + TE. The efficacy will be evaluated
        in terms of reduction of headache episodes, pain intensity and its duration.
  Patients will be evaluated before the start of treatment (T0), at the end of treatment (T1),
        3 months after T1 (T2), 6 months after T1 (T3). Results will be stratified by gender, age
        range, and type of headache diagnosed.
  
        The 3 non-pharmacological treatment groups will carry out 12 treatment sessions, 3 times a
        week for 4 weeks, with a duration of 45 minutes each. The control group (CTRL) will carry out
        pharmacological treatment according to clinical practice, the patients of the CTRL group at
        the end of the last follow-up evaluation (T3 at 6 months) at their request will be randomized
        into one of the other three intervention groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The allocation sequence will occur by 1:1:1:1 randomization, using the Clinical Trial Randomization tool (web https://ctrandomization.cancer.gov/), stratifying by headache type. The allocation of patients will be hidden, through the use of sealed envelopes in which the randomization will be contained. The enrollment will be carried out by the medical doctors of the Headache and Neurosonology Center clinics of the Campus Bio-Medico University Hospital Foundation, who will communicate the patient's name to a third person external to the study who will assign the patient according to the randomization plan developed.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: the assessor is unaware of the type of treatment the patients have received
  measure: Headache frequency
  time frame: 4 weeks (end of treatment)
  description: number of headache attacks in one month
  measure: Headache frequency
  time frame: 3 months after the end of the treatment
  description: number of headache attacks in one month
  measure: Headache frequency
  time frame: 6 months after the end of the treatment
  description: number of headache attacks in one month
  measure: Headache clinical presentation
  time frame: 4 weeks (end of treatment)
  description: the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
  measure: Headache clinical presentation
  time frame: 3 months after the end of the treatment
  description: the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
  measure: Headache clinical presentation
  time frame: 6 months after the end of the treatment
  description: the Visual Analogue Scale corresponds to the visual representation of the amplitude of pain felt by the patient at rest and in movement of the headache symptom. The scale consists in a straight horizontal line of100 mm length. The ends are defined as the extreme limits of the pain, and is orientated from the left (no pain) to the right (worst pain)
  measure: Headache related disability
  time frame: 4 weeks (end of treatment)
  description: The headache related disability is assessed through the neck disability index
  measure: Headache related Disability
  time frame: 3 months after the end of the treatment
  description: The headache related disability is assessed through the neck disability index
  measure: Headache related Disability
  time frame: 6 months after the end of the treatment
  description: The headache related disability is assessed through the neck disability index
  measure: Headache related Disability
  time frame: 4 weeks (end of treatment)
  description: The headache related disability is assessed through the migraine disability assessment test.
  measure: Headache related Disability
  time frame: 3 months after the end of the treatment;
  description: The headache related disability is assessed through the migraine disability assessment test.
  measure: Headache related Disability
  time frame: 6 months after the end of the treatment
  description: The headache related disability is assessed through the migraine disability assessment test.
  measure: Perceived Quality of life
  time frame: 4 weeks (end of treatment)
  description: The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
  measure: Perceived Quality of life
  time frame: 3 months after the end of the treatment
  description: The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
  measure: Perceived Quality of life
  time frame: 6 months after the end of the treatment
  description: The quality of life is assessed through the Migraine-Specific Quality of Life Questionnaire (MSQ)
  measure: Perceived Quality of life
  time frame: 4 weeks (end of treatment)
  description: The quality of life is assessed through the Short Form-36 Health Survey
  measure: Perceived Quality of life
  time frame: 3 months after the end of the treatment
  description: The quality of life is assessed through the Short Form-36 Health Survey
  measure: Perceived Quality of life
  time frame: 6 months after the end of the treatment
  description: The quality of life is assessed through the Short Form-36 Health Survey
  measure: Cervical Range of Motion
  time frame: 4 weeks (end of treatment)
  description: Active cervical range of motion recorded through the dynamo vald system
  measure: Cervical Range of Motion
  time frame: 3 months after the end of the treatment
  description: Active cervical range of motion recorded through the dynamo vald system
  measure: Cervical Range of Motion
  time frame: 6 months after the end of the treatment
  description: Active cervical range of motion recorded through the dynamo vald system
  measure: Cervical muscles Strength
  time frame: 4 weeks (end of treatment)
  description: Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
  measure: Cervical muscles Strength
  time frame: 3 months after the end of the treatment
  description: Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
  measure: Cervical muscles Strength
  time frame: 6 months after the end of the treatment
  description: Peak strength of the neck muscles will be measured with the Dynamo portable dynamometer (VALD Performance, Australia)
  measure: Drug intake
  time frame: 4 weeks (end of treatment)
  description: Number of drug intake reported in the headache diary
  measure: Drug intake
  time frame: 3 months after the end of the treatment
  description: Number of drug intake reported in the headache diary
  measure: Drug intake
  time frame: 6 months after the end of the treatment
  description: Number of drug intake reported in the headache diary
  arm group label: Myofascial Release (MR) + Therapeutic exercise (TE)
  arm group type: Experimental
  description: Patients in the MR+TE group will undergo 12 sessions (3 d/week) of sub-occipital inhibition treatment as a combined muscle and soft tissue inhibition technique. The physiotherapist will apply deep pressure which will be maintained for a total of 10 minutes until the sub-occipital tissues are released. In addition to this technique, the method of pumping and manual treatment (acupressure) of the trigger points on the sub-occipital muscles, on the upper bundles of the trapezius bilaterally, on the sternocleidomastoid bilaterally and on the scalene muscles bilaterally will be applied for a further 10 minutes for a total treatment with myofascial release equal to 20 minutes. At the end of the MR session, the 20-minute TE session will be performed in the same way as described in the TE intervention group.
  arm group label: Manual therapy (MT) + Therapeutic exercise (TE)
  arm group type: Experimental
  description: The MT+TE intervention group will carry out rehabilitation treatment with a structured protocol based on mobilizations according to the Mulligan method. Treatment according to Mulligan will be carried out at the discretion of the therapist on the basis of daily evaluations of cervical dysfunction and the eventual manifestation of headache. 5 different techniques will be performed on the patient in 12 sessions (3 v/week, for 4 weeks) as described in Satpute, K., Bedekar, N. & Hall, T. Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. BMC Musculoskelet Disord 22, (2021)..
  arm group label: Therapeutic exercise (TE)
  arm group type: Experimental
  description: Patients in the TE intervention group will be asked to perform 12 sessions (3 day/week) of TE supervised by a physiotherapist. Each session will have a total duration of 40 min divided into 20 min of aerobic exercise and 20 min of TE. Aerobic exercise consists of a total of 20 min of activity on a stationary bike using parameters to increase performance (intensity over 20 min) progressively based on fatigue (Borg scale).The TE consists of warm-up and cool-down exercises for the cervical ROM, associated with stretching exercises of the cervical and scapulothoracic muscles. After the warm-up, muscle strengthening exercises will be performed (isometric, concentric and eccentric contractions of the cervical muscles).
  arm group label: Control
  arm group type: Active Comparator
  description: Patients assigned to the control group will follow the pharmacological treatment according to medical doctor indications (clinical practice).
  intervention type: Other
  intervention name: Myofascial Release (MR)
  description: Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout myofascial tissues.
  arm group label: Myofascial Release (MR) + Therapeutic exercise (TE)
  intervention type: Drug
  intervention name: clinical practice drug treatment
  description: drug treatment according to the medical indications of clinical practice
  arm group label: Control
  intervention type: Other
  intervention name: Manual therapy (MT)
  description: The manual therapy consists of the concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. Passive end-of-range overpressure, or stretching, is then delivered without pain as a barrier.
  arm group label: Manual therapy (MT) + Therapeutic exercise (TE)
  other name: Mulligan Concept
  intervention type: Other
  intervention name: Therapeutic exercise (TE)
  description: The ET consists of an initial phase of aerobic exercise (cyclette), subsequently the intervention foresees exercises for the cervical ROM, stretching exercises of the cervical and scapulothoracic muscles and muscle strengthening exercises (isometric, concentric and eccentrics of the cervical musculature).
  arm group label: Manual therapy (MT) + Therapeutic exercise (TE)
  arm group label: Myofascial Release (MR) + Therapeutic exercise (TE)
  arm group label: Therapeutic exercise (TE)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Silvia Sterzi, MD
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario Campus Bio-Medico
  last name: Silvia Sterzi, MD
  phone: +390622541624
  email: s.sterzi@policlinicocampus.it
  last name: Marco Bravi, PT
  phone: +393285357278
  email: m.bravi@policlinicocampus.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Campus Bio-Medico University
  investigator full name: Silvia Sterzi
  investigator title: Director of Physical Medicine and Rehabilitative Unit
  mesh term: Headache