<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/NCT04496440</url>
  </required_header>
  <id_info>
    <org_study_id>1001</org_study_id>
    <nct_id>NCT04496440</nct_id>
  </id_info>
  <brief_title>An Attempt to Find Out Root Cause of a Pain Producing Knee Disease</brief_title>
  <official_title>Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DR R C Agrawal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Knee Pain Clinic</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>
      This study was focused on a type of arthritis (knee) in which patients develop pain with&#xD;
      disabilities in sitting and walking etc. In advance stage the person is bereft of his/her&#xD;
      personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A&#xD;
      new treatment was designed and a trial was conducted on 125 patients (100 in the trial group,&#xD;
      25 in the control group) for a duration of six months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was focused on establishing the cause and treatment of a painful knee joint disease&#xD;
      (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known.&#xD;
      The study was based on a hypothesis, designing a treatment and testing it through a clinical&#xD;
      trial. This established that the deficient full flexion or deficient full extension of knee&#xD;
      joints, producing contracture in their capsules was the cause and the correction (Contracture&#xD;
      Correction Therapy = CCT) was the cure of the disease. The correction was carried out by&#xD;
      passive flexion or passive extension of affected knee through eight body postures designed&#xD;
      specifically during the study.&#xD;
&#xD;
      To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was&#xD;
      carried out, patients were divided into Trial and Control groups. The effects were measured&#xD;
      by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index&#xD;
      (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF*, DFE^ at&#xD;
      0, 6 ,12 and 24 weeks.&#xD;
&#xD;
      The &quot;Intervention&quot; for 1st group was CCT and for the 2nd group was &quot;No intervention&quot;.&#xD;
&#xD;
      * Deficient full flexion&#xD;
&#xD;
      ^ Deficient full extension&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>WOMAC Knee Arthritis score</measure>
    <time_frame>6 Months</time_frame>
    <description>The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on a five point likert-type scale. Range 0-96, 0=BEST and 96=WORST. To access a change from baseline score at six months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EuroQol visual analogue scale (EQ-VAS)</measure>
    <time_frame>6 Months</time_frame>
    <description>A 20 centimetre vertical visual analogue scale (EQ-VAS), that takes values between 100 (best imaginable health) and 0 (worst imaginable health). To access a change from baseline score at six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deficient Full Flexion (DFF)</measure>
    <time_frame>6 Months</time_frame>
    <description>The degree by which flexion is lesser then 145°. Full flexion is measured by Goniometer, expressed in blocks of 5°, such as 140°, 135°, 130° etc. In first case DFF is 145-140 = 5°. Higher degree of DFF denotes higher severity. To access a change from baseline score at six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deficient Full Extension (DFE)</measure>
    <time_frame>6 Months</time_frame>
    <description>The degree by which full extension falls short to 0°. When full Range of Motion (ROM) is 0-145° and full extension is 145° the Full extension is should be 0.The DFE are represented by 5°, 10°, 15° etc. Higher degree of DFE denotes higher severity. To access a change from baseline score at six months.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">138</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Arthroplasty</condition>
  <condition>Knee</condition>
  <arm_group>
    <arm_group_label>Trial Group</arm_group_label>
    <description>Contracture correction therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>No new intervention, patients continued with the previous treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contracture Correction Therapy</intervention_name>
    <description>Non-drug and non-surgical treatment of contracted knee capsules</description>
    <arm_group_label>Trial Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Gwalior a city in India and multiple surrounding towns&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age =&gt;30 years&#xD;
&#xD;
          -  Knee pain which appeared without any apparent cause, exacerbated by exertion and&#xD;
             subsided by rest.&#xD;
&#xD;
          -  Presence of limited morning stiffness&#xD;
&#xD;
          -  No history of infection, inflammation or trauma to rule out secondary OA&#xD;
&#xD;
          -  Disability in sitting, climbing stairs or walking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Backache&#xD;
&#xD;
          -  Leg pain (e.g. sciatica)&#xD;
&#xD;
          -  Inability to lie supine (e.g. kyphosis)&#xD;
&#xD;
          -  Inability to lie prone (e.g. central obesity)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R C Agrawal, MBBS,MS,FICS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Knee Pain Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arogya Sadan Nursing Home</name>
      <address>
        <city>Bhind</city>
        <state>Madhya Pradesh</state>
        <zip>477001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sai Baba Dharmarth Chikitsalaya</name>
      <address>
        <city>Gwalior</city>
        <state>Madhya Pradesh</state>
        <zip>474003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parashar Poly Clinic</name>
      <address>
        <city>Gwalior</city>
        <state>Madhya Pradesh</state>
        <zip>474010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knee Pain Clinic</name>
      <address>
        <city>Gwalior</city>
        <state>Madhya Pradesh</state>
        <zip>474012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lok Hitkari Trust Health Camp</name>
      <address>
        <city>Gwalior</city>
        <state>Madhya Pradesh</state>
        <zip>474012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Shukla Surgery Center</name>
      <address>
        <city>Morena</city>
        <state>Madhya Pradesh</state>
        <zip>476001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>https://www.orthopaedicscore.com/scorepages/knee_injury_osteopaedic_outcome_score_womac.html</url>
    <description>The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4287662/</url>
    <description>EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 23, 2023</last_update_submitted>
  <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Knee Pain Clinic</investigator_affiliation>
    <investigator_full_name>DR R C Agrawal</investigator_full_name>
    <investigator_title>Senior Surgeon</investigator_title>
  </responsible_party>
  <keyword>Deficient full flexion</keyword>
  <keyword>Deficient full extension</keyword>
  <keyword>Contracture Correction Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT04496440
org study id: 1001
nct id: NCT04496440
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was focused on a type of arthritis (knee) in which patients develop pain with
      disabilities in sitting and walking etc. In advance stage the person is bereft of his/her
      personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A
      new treatment was designed and a trial was conducted on 125 patients (100 in the trial group,
      25 in the control group) for a duration of six months.
The study was focused on establishing the cause and treatment of a painful knee joint disease
      (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known.
      The study was based on a hypothesis, designing a treatment and testing it through a clinical
      trial. This established that the deficient full flexion or deficient full extension of knee
      joints, producing contracture in their capsules was the cause and the correction (Contracture
      Correction Therapy = CCT) was the cure of the disease. The correction was carried out by
      passive flexion or passive extension of affected knee through eight body postures designed
      specifically during the study.

      To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was
      carried out, patients were divided into Trial and Control groups. The effects were measured
      by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index
      (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF*, DFE^ at
      0, 6 ,12 and 24 weeks.

      The "Intervention" for 1st group was CCT and for the 2nd group was "No intervention".

      * Deficient full flexion

      ^ Deficient full extension
observational model: Case-Control
time perspective: Retrospective
measure: WOMAC Knee Arthritis score
time frame: 6 Months
description: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on a five point likert-type scale. Range 0-96, 0=BEST and 96=WORST. To access a change from baseline score at six months.
measure: EuroQol visual analogue scale (EQ-VAS)
time frame: 6 Months
description: A 20 centimetre vertical visual analogue scale (EQ-VAS), that takes values between 100 (best imaginable health) and 0 (worst imaginable health). To access a change from baseline score at six months.
measure: Deficient Full Flexion (DFF)
time frame: 6 Months
description: The degree by which flexion is lesser then 145°. Full flexion is measured by Goniometer, expressed in blocks of 5°, such as 140°, 135°, 130° etc. In first case DFF is 145-140 = 5°. Higher degree of DFF denotes higher severity. To access a change from baseline score at six months.
measure: Deficient Full Extension (DFE)
time frame: 6 Months
description: The degree by which full extension falls short to 0°. When full Range of Motion (ROM) is 0-145° and full extension is 145° the Full extension is should be 0.The DFE are represented by 5°, 10°, 15° etc. Higher degree of DFE denotes higher severity. To access a change from baseline score at six months.
arm group label: Trial Group
description: Contracture correction therapy
arm group label: Control Group
description: No new intervention, patients continued with the previous treatment.
intervention type: Other
intervention name: Contracture Correction Therapy
description: Non-drug and non-surgical treatment of contracted knee capsules
arm group label: Trial Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: R C Agrawal, MBBS,MS,FICS
role: Principal Investigator
affiliation: Knee Pain Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
url: https://www.orthopaedicscore.com/scorepages/knee_injury_osteopaedic_outcome_score_womac.html
description: The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee.
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4287662/
description: EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.
responsible party type: Sponsor-Investigator
investigator affiliation: Knee Pain Clinic
investigator full name: DR R C Agrawal
investigator title: Senior Surgeon
mesh term: Osteoarthritis
sharing ipd: No