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/NCT06042465</url>
    </required_header>
    <id_info>
      <org_study_id>ACAO/L53/AY/2018</org_study_id>
      <nct_id>NCT06042465</nct_id>
    </id_info>
    <brief_title>Investigation on Efficacy Between TCM Treatment Using Acupuncture and Tui-na With Physiotherapy on Patellofemoral Pain Syndrome</brief_title>
    <official_title>Investigation on the Efficacy Between TCM Treatment Using Acupuncture and Tui-na Manipulation With Physiotherapy on Patellofemoral Pain Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hong Kong Baptist University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hong Kong Baptist Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hong Kong Baptist 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>
        Knee pain is one of common pain-causing diseases and it affects patients' mobility which in&#xD;
        turn seriously affects the quality of patients' life. The most common cause of knee pain&#xD;
        results from the inflammation occurred at the patallo-femoral joint of the anterior knee. It&#xD;
        is now commonly recognized as Patello-femoral pain syndrome (PFPS). It is categorized as&#xD;
        anterior knee pain.&#xD;
  &#xD;
        The exact pathogenesis of PFPS is still not clear but both TCM and WM have many treatment&#xD;
        methods. Hence, it is important and meaningful to investigate the diagnosis and treatment in&#xD;
        detail. Through reviewing the literature about PFPS, we would like to achieve the following&#xD;
        objectives in our study design. Under the principle of evidence-based medicine, we compare&#xD;
        the clinical effectiveness of TCM acupuncture and Tui-na manipulations treatment with the&#xD;
        physiotherapy on the PFPS management. The study is to determine whether which are effective&#xD;
        in improving knee function and lessening the pain in PFPS patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The target sample size will be 180 patients approximately, each group namely TCM/PT/Education&#xD;
        group respectively will contain minimum 60 patients respectively. Patients are initially&#xD;
        screened with questionnaire implying the PFPS scouring system. Patients will be recruited and&#xD;
        firstly screened from SCM. Then the secondary screening will be conducted by the WM&#xD;
        practitioner in Hong Kong Baptist Hospital (HKBH) to confirm diagnosis and enrollment based&#xD;
        on the inclusion and exclusion criteria. X-ray imaging diagnosis and reporting are done in&#xD;
        HKBH.&#xD;
  &#xD;
        We will design a randomized controlled trial, compared with TCM group and PT group. Patients&#xD;
        are requested to sign a consent form before enter the washout period for 2 weeks before they&#xD;
        start their interventions. TCM group will receive acupuncture and Tui-na. PT group will&#xD;
        receive physiotherapy training. Patients will be treated twice a week and rest on 3rd and 6th&#xD;
        week. Total 12 sessions treatments within 8 weeks. We set up a control group named &quot;education&#xD;
        group&quot;, the control group will be used to compare with the other two groups. Included&#xD;
        patients in this group are provided with educational talk on knee health protection. Patients&#xD;
        are advised with daily-life protection on their PFPS. After 8 weeks of control intervention,&#xD;
        patients are given with treatment same as TCM group or PT group in 1:1 basis. Phone-follow up&#xD;
        will start from 3-month after the treatment.&#xD;
  &#xD;
        Statistical analysis will be performed using the Social Science Statistics Package (SPSS) for&#xD;
        Windows version. We are going to (1)analysis of the PFPS diagnostic criteria; (2)Comparison&#xD;
        between the questionnaire and examinations before and after the treatment intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 18, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 18, 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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effectiveness Measurement</measure>
      <time_frame>3 months</time_frame>
      <description>The expected outcomes are both interventions have effectiveness on curing the PFPS. Traditional Chinese Medicine group and Physiotherapy group have better effectiveness than control group in treating PFPS. By according to the Visual Analogue Scale score and the before and after evaluation form, it indicates whether the pain condition has improved.&#xD;
  (Visual Analogue Scale will be indicated from 0 to 10. Which 0 stand for no pain at all and 10 marks stand for the worst pain).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Patellofemoral Pain Syndrome</condition>
    <condition>Acupuncture</condition>
    <condition>Physiotherapy</condition>
    <arm_group>
      <arm_group_label>TCM group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PT group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>As decided and performed by physiotherapist of HKBH on standardized treatment method</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Educational Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Included patients in this group are provided with educational talk on knee health protection. Patients are advised with daily-life protection on their PFPS. Questionnaire assessments are performed to assess the healthy situation of their PFPS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>acupuncture and Tui-na manipulations</intervention_name>
      <description>i. Patients in supine position with knee elevated 20-30 degrees bending using a pillow below.&#xD;
  ii. Acupuncture needle using 0.25 mm diameter and 1.5-inch length. iii. Choose 'A shi point' to inject the acupuncture needles. iv. Inject 4 acupuncture needles respectively at the upper, lower, lateral and medial edge of the patella, along the medial and lateral edge at the posterior surface of patella.&#xD;
  v. Connect the needles with electro-therapy, selecting high frequency and strength that the patients have sensation and acceptable. Time duration is 30 minutes each time. Infra-radiation is provided and warm above the treatment region.&#xD;
  vi. Tui-na manipulations using the method of 'Tui-na'. Time duration is 2-5 minutes. Patella is pushed up and elevated during treatment.&#xD;
  vii. No external herbal medicine for TCM group , other medication such as painkiller is required to record</description>
      <arm_group_label>TCM group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physiotherapy</intervention_name>
      <description>i. Total 12 sessions of physiotherapy for 8 weeks training; ii. Treatment: Closed kinetic chain exercises program will be used when appropriate, which include:&#xD;
  Mini walk squat exercise&#xD;
  Forward step up&#xD;
  Lateral step up&#xD;
  Terminal knee extension&#xD;
  Knee taping&#xD;
  Unstable base training&#xD;
  Pain control&#xD;
  Manual Therapy Each session will approximately cost each patient 1 hours' time. There is no Chinese medicine is allowed for PT group , other medication such as painkiller is required to record.</description>
      <arm_group_label>PT group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18 and 70, male and female, knee pain as main complaint;&#xD;
  &#xD;
            2. Diagnosed as PFPS using our diagnostic standard;&#xD;
  &#xD;
            3. Knee pain for more than 1 month;&#xD;
  &#xD;
            4. Patients could be able to finish all questionnaires, treatment;&#xD;
  &#xD;
            5. Insidious onset of symptoms unrelated to a traumatic incident and persistent for at&#xD;
               least 6 weeks;&#xD;
  &#xD;
            6. Able to cooperate with questionnaires, examination and treatment and follow-up cycles;&#xD;
  &#xD;
            7. Agree to receive regular Chinese medicine diagnosis and assist in the designated&#xD;
               examinations in the study.&#xD;
  &#xD;
            8. Agree to record physical condition indicators and report the situation at each&#xD;
               follow-up consultation.&#xD;
  &#xD;
            9. During the entire plan period, the subjects must agree not to use any type of Chinese&#xD;
               medicine health care products until the end of the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age below 18 and above 70; Patients with Body Mass Index (BMI)≧30;&#xD;
  &#xD;
            2. Patients with acute traumatic bone fracture, dislocation or acute soft tissue injury&#xD;
               at knee joint;&#xD;
  &#xD;
            3. Patients with infections at knee joint;&#xD;
  &#xD;
            4. Patients with non-specific inflammation at knee joint and rheumatoid disease;&#xD;
  &#xD;
            5. Patients with ostomy or other tumor related;&#xD;
  &#xD;
            6. Patients with knee pain but not anterior knee pain, e.g. meniscal or other intra&#xD;
               articular pathologic condition, cruciate or collateral ligament cases, patella&#xD;
               subluxation or dislocation, previous surgery in the knee and hip joints, knee and hip&#xD;
               joint osteoarthritis, any conditions affect muscle strength like diabetes mellitus or&#xD;
               rheumatoid arthritis；&#xD;
  &#xD;
            7. Patients with patellar tendon inflammation or Osgood-Schlatter Disease;&#xD;
  &#xD;
            8. Any psychiatric disorder;&#xD;
  &#xD;
            9. Pregnancy;&#xD;
  &#xD;
           10. Patients with severe disease such as immune disease, genetic disease and severe&#xD;
               coronary vascular disease;&#xD;
  &#xD;
           11. Patients receive any other treatment such as physiotherapy or acupuncture after&#xD;
               washout period.&#xD;
  &#xD;
           12. If participants are incompetent in giving consent .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kevin Kin Man Yue</last_name>
      <phone>34112468</phone>
      <email>kkmyue@hkbu.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kevin Yue Kin Man</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kevin Kin Man Yue</last_name>
        <phone>34112468</phone>
        <email>kkmyue@hkbu.edu.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</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/NCT06042465
  org study id: ACAO/L53/AY/2018
  nct id: NCT06042465
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Knee pain is one of common pain-causing diseases and it affects patients' mobility which in
        turn seriously affects the quality of patients' life. The most common cause of knee pain
        results from the inflammation occurred at the patallo-femoral joint of the anterior knee. It
        is now commonly recognized as Patello-femoral pain syndrome (PFPS). It is categorized as
        anterior knee pain.
  
        The exact pathogenesis of PFPS is still not clear but both TCM and WM have many treatment
        methods. Hence, it is important and meaningful to investigate the diagnosis and treatment in
        detail. Through reviewing the literature about PFPS, we would like to achieve the following
        objectives in our study design. Under the principle of evidence-based medicine, we compare
        the clinical effectiveness of TCM acupuncture and Tui-na manipulations treatment with the
        physiotherapy on the PFPS management. The study is to determine whether which are effective
        in improving knee function and lessening the pain in PFPS patients.
  The target sample size will be 180 patients approximately, each group namely TCM/PT/Education
        group respectively will contain minimum 60 patients respectively. Patients are initially
        screened with questionnaire implying the PFPS scouring system. Patients will be recruited and
        firstly screened from SCM. Then the secondary screening will be conducted by the WM
        practitioner in Hong Kong Baptist Hospital (HKBH) to confirm diagnosis and enrollment based
        on the inclusion and exclusion criteria. X-ray imaging diagnosis and reporting are done in
        HKBH.
  
        We will design a randomized controlled trial, compared with TCM group and PT group. Patients
        are requested to sign a consent form before enter the washout period for 2 weeks before they
        start their interventions. TCM group will receive acupuncture and Tui-na. PT group will
        receive physiotherapy training. Patients will be treated twice a week and rest on 3rd and 6th
        week. Total 12 sessions treatments within 8 weeks. We set up a control group named "education
        group", the control group will be used to compare with the other two groups. Included
        patients in this group are provided with educational talk on knee health protection. Patients
        are advised with daily-life protection on their PFPS. After 8 weeks of control intervention,
        patients are given with treatment same as TCM group or PT group in 1:1 basis. Phone-follow up
        will start from 3-month after the treatment.
  
        Statistical analysis will be performed using the Social Science Statistics Package (SPSS) for
        Windows version. We are going to (1)analysis of the PFPS diagnostic criteria; (2)Comparison
        between the questionnaire and examinations before and after the treatment intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Effectiveness Measurement
  time frame: 3 months
  description: The expected outcomes are both interventions have effectiveness on curing the PFPS. Traditional Chinese Medicine group and Physiotherapy group have better effectiveness than control group in treating PFPS. By according to the Visual Analogue Scale score and the before and after evaluation form, it indicates whether the pain condition has improved.
  (Visual Analogue Scale will be indicated from 0 to 10. Which 0 stand for no pain at all and 10 marks stand for the worst pain).
  arm group label: TCM group
  arm group type: Experimental
  description: As decided and performed by the registered Chinese Medicine Practitioners (CMP) on standardized treatment method
  arm group label: PT group
  arm group type: Experimental
  description: As decided and performed by physiotherapist of HKBH on standardized treatment method
  arm group label: Educational Group
  arm group type: No Intervention
  description: Included patients in this group are provided with educational talk on knee health protection. Patients are advised with daily-life protection on their PFPS. Questionnaire assessments are performed to assess the healthy situation of their PFPS.
  intervention type: Other
  intervention name: acupuncture and Tui-na manipulations
  description: i. Patients in supine position with knee elevated 20-30 degrees bending using a pillow below.
  ii. Acupuncture needle using 0.25 mm diameter and 1.5-inch length. iii. Choose 'A shi point' to inject the acupuncture needles. iv. Inject 4 acupuncture needles respectively at the upper, lower, lateral and medial edge of the patella, along the medial and lateral edge at the posterior surface of patella.
  v. Connect the needles with electro-therapy, selecting high frequency and strength that the patients have sensation and acceptable. Time duration is 30 minutes each time. Infra-radiation is provided and warm above the treatment region.
  vi. Tui-na manipulations using the method of 'Tui-na'. Time duration is 2-5 minutes. Patella is pushed up and elevated during treatment.
  vii. No external herbal medicine for TCM group , other medication such as painkiller is required to record
  arm group label: TCM group
  intervention type: Other
  intervention name: Physiotherapy
  description: i. Total 12 sessions of physiotherapy for 8 weeks training; ii. Treatment: Closed kinetic chain exercises program will be used when appropriate, which include:
  Mini walk squat exercise
  Forward step up
  Lateral step up
  Terminal knee extension
  Knee taping
  Unstable base training
  Pain control
  Manual Therapy Each session will approximately cost each patient 1 hours' time. There is no Chinese medicine is allowed for PT group , other medication such as painkiller is required to record.
  arm group label: PT group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kevin Kin Man Yue
  phone: 34112468
  email: kkmyue@hkbu.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Sponsor
  mesh term: Patellofemoral Pain Syndrome
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: No