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/NCT05973682</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0127 Kainat</org_study_id>
      <nct_id>NCT05973682</nct_id>
    </id_info>
    <brief_title>Effects of Post Isometric Relaxation With Scapular Stabilization Exercises</brief_title>
    <official_title>Effects of Post Isometric Relaxation With Scapular Stabilization Exercises on Pain, Range of Motion and Disability With Levator Scapulae Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>No</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>
        The levator scapulae is an important postural muscle that tends to shorten or become tight&#xD;
        because of overactivity and bad posture, leading to neck and shoulder pain. Levator scapulae&#xD;
        syndrome is usually caused by the poor shoulders posture as rounded shoulders as sitting at a&#xD;
        computer hunched. It is exacerbated by sustained neck postures, neck movements or levator&#xD;
        scapulae muscle palpation. The aim of study will be to determine the effects of post&#xD;
        isometric relaxation with scapular stabilization exercises on pain, disability and range of&#xD;
        motion in patients with levator scapulae syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A Randomized Controlled Trial will be conducted at Tehsil Headquarter Hospital Sharqpur&#xD;
        Shareef, Sheikhupura through consecutive sampling technique on 30 patients with levator&#xD;
        scapulae syndrome which will be allocated using simple random sampling through sealed opaque&#xD;
        enveloped into Group A and Group B. Group A will be treated with post isometric relaxation,&#xD;
        scapular stabilization exercises along with baseline treatment. Group B will be treated with&#xD;
        post isometric relaxation along with baseline treatment. Baseline treatment includes hot&#xD;
        pack, TENS, upper trapezius stretch, levator scapular stretch and pectoralis major stretch.&#xD;
        Both groups will come thrice per week for a total of 4 weeks. Outcome measures are NPRS,&#xD;
        universal goniometer and NDI. Data will be analysed during SPSS software version 25. After&#xD;
        assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or&#xD;
        non-parametric test will be used within a group or between two groups.&#xD;
  &#xD;
        Keywords: Disability, Levator Scapulae, Range of Motion, Pain&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 20, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Universal Goniometer (UG)</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>Universal Goniometer (UG) used to measure ROM of cervical Spine&#xD;
  A goniometer is an instrument that measures the available range of motion at a joint. Physical therapists commonly use a goniometer to measure the range of motion. The therapist can use a goniometer to assess the range of motion at the initial assessment. In this study range of motion of the neck will be measured.&#xD;
  The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric pain rate scale (NPRS)</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>The numeric pain rate scale (NPRS) measures the pain at the neck region in patients with mechanical neck pain.&#xD;
  The patient's level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates &quot;no pain&quot;, and 10 indicates &quot;worst pain. NPRS is categorized into mild, moderate and severe pain.&#xD;
  Mild pain value 1 to 3 Moderate pain value 4 to 7 Severe pain value 8 to 10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neck Disability index (NDI)</measure>
      <time_frame>upto 4 weeks</time_frame>
      <description>Neck Disability index (NDI) measures the disability of the neck region in patients with mechanical pain.&#xD;
  NDI questionnaire will be used to assess disability. It comprises 10 items; 7 related to daily living activities, 2 related to pain and 1 to concentration. Each item is scored from 0 to 5. The total score is a percentage, with higher scores related to more significant disability.&#xD;
  0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Upper Cross Syndrome</condition>
    <arm_group>
      <arm_group_label>Group A: post isometric relaxation and ConVentional treatment.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Post Isometric Relaxation: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Conventional treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Post-isometric relaxation and Conventional treatment</intervention_name>
      <description>The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.&#xD;
  + hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30 second hold. static stretching exercises two sessions per week for 3 weeks were given to each patient</description>
      <arm_group_label>Group A: post isometric relaxation and ConVentional treatment.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional Physical Therapy</intervention_name>
      <description>Conventional Physical Therapy; hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient</description>
      <arm_group_label>Group A: post isometric relaxation and ConVentional treatment.</arm_group_label>
      <arm_group_label>Group B: Conventional treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both Males and females&#xD;
  &#xD;
            -  Age range of 18-40 years&#xD;
  &#xD;
            -  Neck and medial border scapular pain for at least 3months&#xD;
  &#xD;
            -  Examination - Increased muscle tone and tenderness at neck&#xD;
  &#xD;
            -  Reduced Side flexion and Rotation of neck&#xD;
  &#xD;
            -  Positive Levator Scapular length Test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neuropathies&#xD;
  &#xD;
            -  Vertebral fractures&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Previous cognitive and functional disorders&#xD;
  &#xD;
            -  Traumatic neck injury&#xD;
  &#xD;
            -  Fibromyalgia&#xD;
  &#xD;
            -  cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samrood Akram, Mphil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University,Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samrood Akram, MPhil</last_name>
      <phone>92-3324806143</phone>
      <email>samrood.akram@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samrood Akram, Mphil</last_name>
      <phone>92-3324806143</phone>
      <email>samrood.akram@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tehsil Headquarter Hospital Sharqpur Shareef</name>
        <address>
          <city>Sheikhupura</city>
          <state>Punjab</state>
          <zip>39460</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Samrood Akram, Mphil</last_name>
        <phone>92-3324806143</phone>
        <email>samrood.akram@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Mahmoud NF, Hassan KA, Abdelmajeed SF, Moustafa IM, Silva AG. The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2019 Dec;12(4):562-577. doi: 10.1007/s12178-019-09594-y.</citation>
      <PMID>31773477</PMID>
    </reference>
    <reference>
      <citation>Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.</citation>
      <PMID>30759118</PMID>
    </reference>
    <reference>
      <citation>Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.</citation>
      <PMID>34682453</PMID>
    </reference>
    <reference>
      <citation>Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.</citation>
      <PMID>33187167</PMID>
    </reference>
    <reference>
      <citation>Henry JP, Munakomi S. Anatomy, Head and Neck, Levator Scapulae Muscles. 2022 Aug 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553120/</citation>
      <PMID>31971759</PMID>
    </reference>
    <reference>
      <citation>Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.</citation>
      <PMID>31060367</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neck muscles</keyword>
    <keyword>Neck Pain</keyword>
    <keyword>levator scapulae</keyword>
    <keyword>Range of Motion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05973682
  org study id: REC/RCR & AHS/23/0127 Kainat
  nct id: NCT05973682
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The levator scapulae is an important postural muscle that tends to shorten or become tight
        because of overactivity and bad posture, leading to neck and shoulder pain. Levator scapulae
        syndrome is usually caused by the poor shoulders posture as rounded shoulders as sitting at a
        computer hunched. It is exacerbated by sustained neck postures, neck movements or levator
        scapulae muscle palpation. The aim of study will be to determine the effects of post
        isometric relaxation with scapular stabilization exercises on pain, disability and range of
        motion in patients with levator scapulae syndrome.
  A Randomized Controlled Trial will be conducted at Tehsil Headquarter Hospital Sharqpur
        Shareef, Sheikhupura through consecutive sampling technique on 30 patients with levator
        scapulae syndrome which will be allocated using simple random sampling through sealed opaque
        enveloped into Group A and Group B. Group A will be treated with post isometric relaxation,
        scapular stabilization exercises along with baseline treatment. Group B will be treated with
        post isometric relaxation along with baseline treatment. Baseline treatment includes hot
        pack, TENS, upper trapezius stretch, levator scapular stretch and pectoralis major stretch.
        Both groups will come thrice per week for a total of 4 weeks. Outcome measures are NPRS,
        universal goniometer and NDI. Data will be analysed during SPSS software version 25. After
        assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or
        non-parametric test will be used within a group or between two groups.
  
        Keywords: Disability, Levator Scapulae, Range of Motion, Pain
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Universal Goniometer (UG)
  time frame: upto 4 weeks
  description: Universal Goniometer (UG) used to measure ROM of cervical Spine
  A goniometer is an instrument that measures the available range of motion at a joint. Physical therapists commonly use a goniometer to measure the range of motion. The therapist can use a goniometer to assess the range of motion at the initial assessment. In this study range of motion of the neck will be measured.
  The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.
  measure: Numeric pain rate scale (NPRS)
  time frame: upto 4 weeks
  description: The numeric pain rate scale (NPRS) measures the pain at the neck region in patients with mechanical neck pain.
  The patient's level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain", and 10 indicates "worst pain. NPRS is categorized into mild, moderate and severe pain.
  Mild pain value 1 to 3 Moderate pain value 4 to 7 Severe pain value 8 to 10
  measure: Neck Disability index (NDI)
  time frame: upto 4 weeks
  description: Neck Disability index (NDI) measures the disability of the neck region in patients with mechanical pain.
  NDI questionnaire will be used to assess disability. It comprises 10 items; 7 related to daily living activities, 2 related to pain and 1 to concentration. Each item is scored from 0 to 5. The total score is a percentage, with higher scores related to more significant disability.
  0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete
  arm group label: Group A: post isometric relaxation and ConVentional treatment.
  arm group type: Experimental
  description: Post Isometric Relaxation: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.
  arm group label: Group B: Conventional treatment
  arm group type: Active Comparator
  description: hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient
  intervention type: Other
  intervention name: Post-isometric relaxation and Conventional treatment
  description: The term refers to the effect of subsequent relaxation experienced by a muscle or group of muscles, after brief periods during which an isometric contraction has been performed. Post isometric relaxation technique was applied to levator scapulae for 5 repetition using 20% of maximal isometric contraction for 7-10 sec. with complete relaxation of all element, the stretch is maintained for 30 sec.
  + hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30 second hold. static stretching exercises two sessions per week for 3 weeks were given to each patient
  arm group label: Group A: post isometric relaxation and ConVentional treatment.
  intervention type: Other
  intervention name: Conventional Physical Therapy
  description: Conventional Physical Therapy; hot pack and TENS at neck area for 10 mint upper trapezius, levator scapulae and pectoralis stretching 3 times with 30-second hold. static stretching exercises, two sessions per week for 3 weeks were given to each patient
  arm group label: Group A: post isometric relaxation and ConVentional treatment.
  arm group label: Group B: Conventional treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samrood Akram, Mphil
  role: Principal Investigator
  affiliation: Riphah International University,Lahore
  last name: Samrood Akram, MPhil
  phone: 92-3324806143
  email: samrood.akram@riphah.edu.pk
  last name: Samrood Akram, Mphil
  phone: 92-3324806143
  email: samrood.akram@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  citation: Mahmoud NF, Hassan KA, Abdelmajeed SF, Moustafa IM, Silva AG. The Relationship Between Forward Head Posture and Neck Pain: a Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2019 Dec;12(4):562-577. doi: 10.1007/s12178-019-09594-y.
  PMID: 31773477
  citation: Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
  PMID: 30759118
  citation: Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
  PMID: 34682453
  citation: Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.
  PMID: 33187167
  citation: Henry JP, Munakomi S. Anatomy, Head and Neck, Levator Scapulae Muscles. 2022 Aug 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553120/
  PMID: 31971759
  citation: Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
  PMID: 31060367
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No