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/NCT05969912</url>
    </required_header>
    <id_info>
      <org_study_id>REC/01650 Anum Shaheen</org_study_id>
      <nct_id>NCT05969912</nct_id>
    </id_info>
    <brief_title>Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Fibromyalgia</brief_title>
    <official_title>Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Chronic Low Back Pain of Fibromyalgia</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>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>
        To compare the effects of Bowen's and Graston Technique in patients of chronic low back pain&#xD;
        for reducing pain, enhancing lumbar range of motion and physical functioning and reducing&#xD;
        depression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fibromyalgia is a chronic disease of idiopathic etiology, which is estimated to affect 2-4%&#xD;
        of the population. It causes pain, stiffness, and tenderness in muscles, tendons, and joints,&#xD;
        as well as sleep disturbances, fatigue, anxiety, depression, and alterations in intestinal&#xD;
        functions. Chronic low back pain is a pain of more than 12 weeks limited to the lower area of&#xD;
        the back .The chief complaint of a patient with fibromyalgia is widespread musculoskeletal&#xD;
        pain which is bilateral and involves both upper and lower parts of the body. The pain may be&#xD;
        localized initially, commonly in the neck and shoulders. The predominant description of the&#xD;
        pain is muscle pain, but the patients may complain of joint pain as well .&#xD;
  &#xD;
        Grastοn technique is an instrument assisted soft tissue treatment method (ІASTM) derived from&#xD;
        the Cyriax1 cross-friction massage. Physіοtherapist strikes stainless steel instrument in a&#xD;
        longitudinal dіrectіοn and in circular patterns at the treatment site. Many IASTM instruments&#xD;
        including ASTYM, Fascial Abrasion Technique and Graston Technique etc. facilitates the&#xD;
        healing process through increased fibroblast proliferation and increased collagen synthesis,&#xD;
        maturation, and alignment.&#xD;
  &#xD;
        Bowen Therapy is a dynamic fascial and muscle release approach, consisting of gentle&#xD;
        cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle&#xD;
        septa, ligaments and viscera. It is named after Tom Bowen, who created a form of bodywork in&#xD;
        Geelong, Australia and addresses the body as a whole unit rather than just the presenting&#xD;
        symptoms.&#xD;
  &#xD;
        The rationale for the use of these techniques is to identify the effects of IASTM and Bowen&#xD;
        therapy in chronic low back pain of fibromyalgia and to analyze the additional effects of&#xD;
        these techniques by reducing the hyperalgesia and excitability in central nervous system by&#xD;
        working on the descending pain modulation system and to identify the most time effective&#xD;
        treatment for chronic low back pain in fibromyalgia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">April 5, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fibromyalgia impact questionnaire (FIQ)</measure>
      <time_frame>3 weeks</time_frame>
      <description>The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by FM.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Numeric Pain Rating Scale (NPRS)</measure>
      <time_frame>3 weeks</time_frame>
      <description>The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinically useful depression outcome scale (CUDOS)</measure>
      <time_frame>3 weeks</time_frame>
      <description>There are five categories in the empirically derived range of the depression severity of the CUDOS: scores of 11-20 represent minimal depression; 21-30, mild depression; 31-45, moderate depression; and 46 or higher, severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bubble inclinometer</measure>
      <time_frame>3 weeks</time_frame>
      <description>It is an instrument that measures the available range of motion at a joint.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Fibromyalgia</condition>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Graston Technique (Instrumented assisted soft tissue mobilization)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Graston technique + Conventional PT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bowen's Technique (Soft tissue technique)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bowen's technique + Conventional PT</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Graston Technique (Instrumented assisted soft tissue mobilization)</intervention_name>
      <description>They would received Graston technique (Instrumented assisted soft tissue mobilization) as follow:&#xD;
  Using lubricant (Vaseline) on the skin then a stainless steel instrument to relax the fascia and muscles. Frequency: 60 reps per min for 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Graston technique (Instrument assisted soft tissue mobilization)&#xD;
  Additionally, the would receive Conventional PT :&#xD;
  Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks</description>
      <arm_group_label>Graston Technique (Instrumented assisted soft tissue mobilization)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bowen's Technique(Soft tissue technique)</intervention_name>
      <description>They would received Bowen's technique (Soft tissue technique) as follow:&#xD;
  Bowen moves (15 - 20 times) with 2 mins gap between each set. Frequency: 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Bowen's technique (Soft tissue technique)&#xD;
  Additionally, the would receive Conventional PT :&#xD;
  Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks</description>
      <arm_group_label>Bowen's Technique (Soft tissue technique)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 30 and 65 years&#xD;
  &#xD;
            -  Both Genders&#xD;
  &#xD;
            -  Patients with fibromyalgia were included in the study if they fulfilled criteria of&#xD;
               the American college of rheumatology for fibromyalgia.&#xD;
  &#xD;
            -  Patients having chronic mechanical low back pain of more than three months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with tumor, infection and major trauma to the spine causing fracture or&#xD;
               disruption of spine.&#xD;
  &#xD;
            -  Patients with cauda equina syndrome&#xD;
  &#xD;
            -  Any neurological disorder&#xD;
  &#xD;
            -  Any previous spinal fusion surgery or spinal cord stimulation.&#xD;
  &#xD;
            -  Pregnant females&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>KINZA ANWAR, MS-OMPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>KINZA ANWAR, MS-OMPT</last_name>
      <phone>+92-3239735427</phone>
      <email>kinza.anwar@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).</name>
        <address>
          <city>Gujar Khān</city>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>KINZA ANWAR, MS-OMPT</last_name>
        <phone>+92-3239735427</phone>
        <email>kinza.anwar@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>ANUM SHAHEEN</last_name>
      </contact_backup>
      <investigator>
        <last_name>ANUM SHAHEEN, MS-OMPT*</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bowen technique</keyword>
    <keyword>Instrument assisted soft tissue mobilization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back 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>
  
  
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/NCT05969912
  org study id: REC/01650 Anum Shaheen
  nct id: NCT05969912
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To compare the effects of Bowen's and Graston Technique in patients of chronic low back pain
        for reducing pain, enhancing lumbar range of motion and physical functioning and reducing
        depression.
  Fibromyalgia is a chronic disease of idiopathic etiology, which is estimated to affect 2-4%
        of the population. It causes pain, stiffness, and tenderness in muscles, tendons, and joints,
        as well as sleep disturbances, fatigue, anxiety, depression, and alterations in intestinal
        functions. Chronic low back pain is a pain of more than 12 weeks limited to the lower area of
        the back .The chief complaint of a patient with fibromyalgia is widespread musculoskeletal
        pain which is bilateral and involves both upper and lower parts of the body. The pain may be
        localized initially, commonly in the neck and shoulders. The predominant description of the
        pain is muscle pain, but the patients may complain of joint pain as well .
  
        Grastοn technique is an instrument assisted soft tissue treatment method (ІASTM) derived from
        the Cyriax1 cross-friction massage. Physіοtherapist strikes stainless steel instrument in a
        longitudinal dіrectіοn and in circular patterns at the treatment site. Many IASTM instruments
        including ASTYM, Fascial Abrasion Technique and Graston Technique etc. facilitates the
        healing process through increased fibroblast proliferation and increased collagen synthesis,
        maturation, and alignment.
  
        Bowen Therapy is a dynamic fascial and muscle release approach, consisting of gentle
        cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle
        septa, ligaments and viscera. It is named after Tom Bowen, who created a form of bodywork in
        Geelong, Australia and addresses the body as a whole unit rather than just the presenting
        symptoms.
  
        The rationale for the use of these techniques is to identify the effects of IASTM and Bowen
        therapy in chronic low back pain of fibromyalgia and to analyze the additional effects of
        these techniques by reducing the hyperalgesia and excitability in central nervous system by
        working on the descending pain modulation system and to identify the most time effective
        treatment for chronic low back pain in fibromyalgia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Fibromyalgia impact questionnaire (FIQ)
  time frame: 3 weeks
  description: The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by FM.
  measure: Numeric Pain Rating Scale (NPRS)
  time frame: 3 weeks
  description: The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
  measure: Clinically useful depression outcome scale (CUDOS)
  time frame: 3 weeks
  description: There are five categories in the empirically derived range of the depression severity of the CUDOS: scores of 11-20 represent minimal depression; 21-30, mild depression; 31-45, moderate depression; and 46 or higher, severe depression.
  measure: Bubble inclinometer
  time frame: 3 weeks
  description: It is an instrument that measures the available range of motion at a joint.
  arm group label: Graston Technique (Instrumented assisted soft tissue mobilization)
  arm group type: Active Comparator
  description: Graston technique + Conventional PT
  arm group label: Bowen's Technique (Soft tissue technique)
  arm group type: Active Comparator
  description: Bowen's technique + Conventional PT
  intervention type: Other
  intervention name: Graston Technique (Instrumented assisted soft tissue mobilization)
  description: They would received Graston technique (Instrumented assisted soft tissue mobilization) as follow:
  Using lubricant (Vaseline) on the skin then a stainless steel instrument to relax the fascia and muscles. Frequency: 60 reps per min for 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Graston technique (Instrument assisted soft tissue mobilization)
  Additionally, the would receive Conventional PT :
  Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks
  arm group label: Graston Technique (Instrumented assisted soft tissue mobilization)
  intervention type: Other
  intervention name: Bowen's Technique(Soft tissue technique)
  description: They would received Bowen's technique (Soft tissue technique) as follow:
  Bowen moves (15 - 20 times) with 2 mins gap between each set. Frequency: 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Bowen's technique (Soft tissue technique)
  Additionally, the would receive Conventional PT :
  Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks
  arm group label: Bowen's Technique (Soft tissue technique)
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: KINZA ANWAR, MS-OMPT
  role: Principal Investigator
  affiliation: RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
  last name: KINZA ANWAR, MS-OMPT
  phone: +92-3239735427
  email: kinza.anwar@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No