<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/NCT03813680</url>
  </required_header>
  <id_info>
    <org_study_id>1402-PhD-003</org_study_id>
    <nct_id>NCT03813680</nct_id>
  </id_info>
  <brief_title>Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain</brief_title>
  <official_title>Comparison Between Passive Vertebral Mobilization and Proprioceptive Neuromuscular Techniques in Managing Pain and Disability in Patients With Mechanical Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isra University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to determine the effectiveness of Passive Vertebral Mobilization&#xD;
      (PVM) and Proprioceptive Neuromuscular Techniques (PNF) in reducing pain, disability and&#xD;
      improving quality of life in patients with Mechanical Neck Pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck Pain is very common and is now considered a public health issue. It poses significant&#xD;
      health and economic burden, being a frequent cause of disability. A significant proportion of&#xD;
      direct health care costs associated with neck disorders are attributable to visits to health&#xD;
      care providers, to sick leave, and to the related loss of productive capacity. Mechanical&#xD;
      neck pain affects between 45-54% of people in the general population .This can result in&#xD;
      severe pain and disability. Mechanical neck pain described as a reduction in the mobility of&#xD;
      cervical spinal segment is often the focus of manipulative physical therapy interventions.&#xD;
      Most neck pain is not attributed to diseases but rather caused by muscular and postural&#xD;
      condition. The cervical pain is a mechanical problem .It is therefore sense that a mechanical&#xD;
      treatment works better than pharmacological treatment.&#xD;
&#xD;
      Cervical spine often impairs flexibility of key muscles related to cervical spine .&#xD;
      Stretching exercise is beneficial for increasing flexibility as well as muscle performance.&#xD;
&#xD;
      The normal function of cervical spine is complex and requires a large variety of activities&#xD;
      to be coordinated in order for an individual to perform daily activities with the least&#xD;
      amount of strain and potential injury. When the dysfunction develops in the cervical spine, a&#xD;
      chain reaction may develop which can affect the whole neck and even the entire body.&#xD;
&#xD;
      Commonly used approaches to treatment include rest, therapeutic massage, application of&#xD;
      physical agents like heat, cold, TENS, and ultrasonic various types of mobilizations,&#xD;
      manipulations (by physical therapists, chiropractors, osteopaths and others), therapeutic&#xD;
      exercises, postural care and off course medication and surgical interventions. However,&#xD;
      studies of their effectiveness have generally been short-term and inconclusive. The aim of&#xD;
      the study is to compare which treatment either Passive Vertebral Mobilization or&#xD;
      Proprioceptive Neuromuscular Facilitation, whether itself or in combination, is more&#xD;
      effective and beneficial in the treatment of mechanical neck pain.&#xD;
&#xD;
      Several studies have been reported to determine the effectiveness of manual therapy/ passive&#xD;
      vertebral mobilization but with largely inconclusive results. However there are few studies&#xD;
      if any to compare PNF exercise with PVM in terms of their effectiveness. PNF are simple and&#xD;
      requiring low level expertise as compare to PVM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2015</start_date>
  <completion_date type="Actual">March 22, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Randomized Control Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (PAIN)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline. Visual Analog Scale (VAS) is a 10 cm horizontal line, with 0 presenting No pain and 10 representing Worst Pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (Flexion)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (Extension)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline.Bubble inclinometer was used to measure ROM in sitting position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (rotation rightward)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline.Bubble inclinometer was used to measure ROM in sitting position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (rotation leftward)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline. Bubble inclinometer was used to measure ROM in sitting position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (Side bending Right)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline.Bubble inclinometer was used to measure ROM in sitting position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ROM of Cervical spine (Side bending Left)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline.Bubble inclinometer was used to measure ROM in sitting position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Flexors Muscle endurance</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline. Neck Flexion holding time in supine lying position was measured in seconds with the help of stop watch.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NDI (neck Disability Index)</measure>
    <time_frame>4 weeks</time_frame>
    <description>changes from baseline NDI is self rated index to measure pain and disability due to neck pain.&#xD;
Neck disability index consists of 10 questions addressing functional activities. There are 6 potential responses for each item, ranging from no disability (0) to total disability (5).The NDI is scored from 0 to 50 with higher score indication greater disability.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Mechanical Neck Pain</condition>
  <arm_group>
    <arm_group_label>PVM group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group included 30 participants. Passive vertebral mobilization was given along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PNF group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group included 30 participants. PNF exercise in the form of diagonal pattern neck movements was along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RPT(Routine Physiotherapy) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passive Vertebral Mobilization</intervention_name>
    <description>Posteroanterior glides was given to cervical spine using Maitland method along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care</description>
    <arm_group_label>PVM group</arm_group_label>
    <other_name>Spinal mobilization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PNF exercise</intervention_name>
    <description>The subjects was given PNF exercises comprising PNF diagonal patterns for neck along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care</description>
    <arm_group_label>PNF group</arm_group_label>
    <other_name>Proprioceptive Neuromuscular Facilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Physiotherapy</intervention_name>
    <description>Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care</description>
    <arm_group_label>PNF group</arm_group_label>
    <arm_group_label>PVM group</arm_group_label>
    <arm_group_label>RPT(Routine Physiotherapy) group</arm_group_label>
    <other_name>Routine Physical therapy (RPT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mechanical neck pain having limited range of motion and muscle spasm and&#xD;
             difficulty function between 18 to 60 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with rheumatoid arthritis, Ankylosing spondylitis or other systemic&#xD;
             disease&#xD;
&#xD;
          -  Patients with cancer of the cervical spine&#xD;
&#xD;
          -  Patients with history of fracture of spine&#xD;
&#xD;
          -  Patients with any congenital anomaly of Cervical spine&#xD;
&#xD;
          -  Patients having whiplash disorder with in last four weeks&#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>Muhammad Ashfaq</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isra University</affiliation>
  </overall_official>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isra University</investigator_affiliation>
    <investigator_full_name>Muhammad Ashfaq</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mechanical Neck Pain</keyword>
  <keyword>Passive Vertebral Mobilization</keyword>
  <keyword>Proprioceptive Neuromuscular Techniques (PNF)</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Disability</keyword>
  <keyword>Pain</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/NCT03813680
org study id: 1402-PhD-003
nct id: NCT03813680
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to determine the effectiveness of Passive Vertebral Mobilization
      (PVM) and Proprioceptive Neuromuscular Techniques (PNF) in reducing pain, disability and
      improving quality of life in patients with Mechanical Neck Pain.
Neck Pain is very common and is now considered a public health issue. It poses significant
      health and economic burden, being a frequent cause of disability. A significant proportion of
      direct health care costs associated with neck disorders are attributable to visits to health
      care providers, to sick leave, and to the related loss of productive capacity. Mechanical
      neck pain affects between 45-54% of people in the general population .This can result in
      severe pain and disability. Mechanical neck pain described as a reduction in the mobility of
      cervical spinal segment is often the focus of manipulative physical therapy interventions.
      Most neck pain is not attributed to diseases but rather caused by muscular and postural
      condition. The cervical pain is a mechanical problem .It is therefore sense that a mechanical
      treatment works better than pharmacological treatment.

      Cervical spine often impairs flexibility of key muscles related to cervical spine .
      Stretching exercise is beneficial for increasing flexibility as well as muscle performance.

      The normal function of cervical spine is complex and requires a large variety of activities
      to be coordinated in order for an individual to perform daily activities with the least
      amount of strain and potential injury. When the dysfunction develops in the cervical spine, a
      chain reaction may develop which can affect the whole neck and even the entire body.

      Commonly used approaches to treatment include rest, therapeutic massage, application of
      physical agents like heat, cold, TENS, and ultrasonic various types of mobilizations,
      manipulations (by physical therapists, chiropractors, osteopaths and others), therapeutic
      exercises, postural care and off course medication and surgical interventions. However,
      studies of their effectiveness have generally been short-term and inconclusive. The aim of
      the study is to compare which treatment either Passive Vertebral Mobilization or
      Proprioceptive Neuromuscular Facilitation, whether itself or in combination, is more
      effective and beneficial in the treatment of mechanical neck pain.

      Several studies have been reported to determine the effectiveness of manual therapy/ passive
      vertebral mobilization but with largely inconclusive results. However there are few studies
      if any to compare PNF exercise with PVM in terms of their effectiveness. PNF are simple and
      requiring low level expertise as compare to PVM.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Control Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analog Scale (PAIN)
time frame: 4 weeks
description: changes from baseline. Visual Analog Scale (VAS) is a 10 cm horizontal line, with 0 presenting No pain and 10 representing Worst Pain.
measure: ROM of Cervical spine (Flexion)
time frame: 4 weeks
description: changes from baseline
measure: ROM of Cervical spine (Extension)
time frame: 4 weeks
description: changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
measure: ROM of Cervical spine (rotation rightward)
time frame: 4 weeks
description: changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
measure: ROM of Cervical spine (rotation leftward)
time frame: 4 weeks
description: changes from baseline. Bubble inclinometer was used to measure ROM in sitting position
measure: ROM of Cervical spine (Side bending Right)
time frame: 4 weeks
description: changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
measure: ROM of Cervical spine (Side bending Left)
time frame: 4 weeks
description: changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
measure: Neck Flexors Muscle endurance
time frame: 4 weeks
description: changes from baseline. Neck Flexion holding time in supine lying position was measured in seconds with the help of stop watch.
measure: NDI (neck Disability Index)
time frame: 4 weeks
description: changes from baseline NDI is self rated index to measure pain and disability due to neck pain.
Neck disability index consists of 10 questions addressing functional activities. There are 6 potential responses for each item, ranging from no disability (0) to total disability (5).The NDI is scored from 0 to 50 with higher score indication greater disability.
arm group label: PVM group
arm group type: Active Comparator
description: This group included 30 participants. Passive vertebral mobilization was given along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care
arm group label: PNF group
arm group type: Active Comparator
description: This group included 30 participants. PNF exercise in the form of diagonal pattern neck movements was along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care
arm group label: RPT(Routine Physiotherapy) group
arm group type: Active Comparator
description: This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.
intervention type: Other
intervention name: Passive Vertebral Mobilization
description: Posteroanterior glides was given to cervical spine using Maitland method along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
arm group label: PVM group
other name: Spinal mobilization
intervention type: Other
intervention name: PNF exercise
description: The subjects was given PNF exercises comprising PNF diagonal patterns for neck along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
arm group label: PNF group
other name: Proprioceptive Neuromuscular Facilitation
intervention type: Other
intervention name: Routine Physiotherapy
description: Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
arm group label: PNF group
arm group label: PVM group
arm group label: RPT(Routine Physiotherapy) group
other name: Routine Physical therapy (RPT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Muhammad Ashfaq
role: Principal Investigator
affiliation: Isra University
responsible party type: Principal Investigator
investigator affiliation: Isra University
investigator full name: Muhammad Ashfaq
investigator title: Principal Investigator
mesh term: Neck Pain
sharing ipd: No