<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/NCT03751267</url>
  </required_header>
  <id_info>
    <org_study_id>UW18-132</org_study_id>
    <nct_id>NCT03751267</nct_id>
  </id_info>
  <brief_title>Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children</brief_title>
  <official_title>Effects of Paediatric Tuina (Massage) on Constipation and Related Symptoms Among the Pre-school Aged Children - a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      The research is a collaborative project by HKU and Yan Chai Hospital, funded by Social&#xD;
      Welfare Development Fund of HKSAR. The study is designed as a prospective randomized control&#xD;
      trial with the primary objective to investigate the efficacy of pediatric tuina (massage) on&#xD;
      the functional constipation of pre-school aged children.&#xD;
&#xD;
      Our study is a pragmatic research comparing the pediatrictuina(massage)treatment with care as&#xD;
      usual, with the objectives of investigating&#xD;
&#xD;
        1. if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the&#xD;
           constipation and related symptoms experienced by the pre-school age children&#xD;
&#xD;
        2. if there is a positive impact on the caregiver-children relationship and the children's&#xD;
           behaviour (a sub-group analysis) when the constipation symptoms improved.&#xD;
&#xD;
      The subjects of this study are pre-school age children (age 2-6) who are serviced by Yan Chai&#xD;
      Hospital Social Service Department (YCHSS).The subjects will be openly recruited through the&#xD;
      service units serving pre-school aged children under YCHSS. Rome IV criteria will be used to&#xD;
      identify the children who suffer from constipation.&#xD;
&#xD;
      I. Trial Design This is a multicentre, pragmatic randomized control trial (PRCT) with a&#xD;
      prospective design&#xD;
&#xD;
      Hypothesis 1:&#xD;
&#xD;
      Applying regular pediatrictuina (massage) (3 times a week, for 4 weeks ) on pre-school aged&#xD;
      children with functional constipation will improve one or more of the following symptoms.&#xD;
&#xD;
        -  Frequency of defecations&#xD;
&#xD;
        -  Episode of incontinence&#xD;
&#xD;
        -  Excessive stool retention&#xD;
&#xD;
        -  Painful or hard bowel movements&#xD;
&#xD;
        -  Presence of a large fecal mass in the rectum that may obstruct the toilet&#xD;
&#xD;
      Hypothesis 2:&#xD;
&#xD;
      The stress level of the caregiver of the study subjects improve as the constipation syndrome&#xD;
      of the subjects improve.&#xD;
&#xD;
      Hypothesis 3:&#xD;
&#xD;
      The children with behavior problem who suffered from constipation will have less behavior&#xD;
      issue when their functional constipation syndromes improved&#xD;
&#xD;
      Total 160 pre-school aged children with functional constipation and their caregiver will be&#xD;
      openly recruited from the institutions/service units operated by the pediatric service unit&#xD;
      of Yan Chai Hospital Social Service Department.The recruited children must suffer from&#xD;
      functional constipation symptoms (based on Rome IV criteria). All accepted subjects will be&#xD;
      in dyad. (i.e. 1 pre-school aged child and his designated caregiver, who commits bring the&#xD;
      child to attend all treatment and assessment sessions, respond to all caregivers' assessment&#xD;
      and fill in the daily logbook).&#xD;
&#xD;
      All applications will be screened by the social workers in the centres based on the inclusion&#xD;
      and exclusion criteria. Qualified applicants will be invited for a health assessment&#xD;
      conducted by registered TCM practitioner in the research team to confirm their suitability&#xD;
      and invite them to sign the consent form. The consented dyad will be allocated randomly into&#xD;
      treatment group and waitlist control group.&#xD;
&#xD;
      II. Intervention A 10 minutes structured pediatric massage protocol with specific&#xD;
      applications technique will be performed on the children allocated to the treatment group&#xD;
      three times a week for 4 consecutive weeks by trained TCM practitioners in the service units&#xD;
      of YCHSS. The caregivers of the children need to participate in all assessment sessions and&#xD;
      fill in the log book provided.&#xD;
&#xD;
      In the 1st 4 weeks, the children in the waitlist control group will not receive any&#xD;
      pediatrictuina (massage). After the dyad completed the assessment sessions at baseline and&#xD;
      week 4 ,(served as Treatment-as-Usual Control), children in the control group will receive&#xD;
      the same 4 weeks of pediatric massage as the treatment group. The data collected before the&#xD;
      treatment begins at week 4 will serve as the 2nd baseline for the waitlist control group.&#xD;
&#xD;
      The treatment protocol involve 8 steps.The massage area focuses on the abdomen and lower back&#xD;
      of the recipients. All the movements/steps selected are well established and commonly used in&#xD;
      the TCM practices. Any movement that demand professional training or involve potential risk&#xD;
      is excluded from the protocol.&#xD;
&#xD;
      III. Measurement of efficacy Efficacy of the treatments will be measured in multi dimensions&#xD;
      before and after the treatment for both groups. The main outcome measures are defecation&#xD;
      frequency per week, fecal incontinence frequency per week, and overall treatment success&#xD;
      after 4 weeks intervention, 8 weeks intervention and 12 weeks (4 weeks after intervention&#xD;
      stopped) Secondary outcome measures included&#xD;
&#xD;
        -  abdominal pain and painful defecation based on bowel diary,&#xD;
&#xD;
        -  the children's subjective level of pain during bowel movement,&#xD;
&#xD;
        -  score of child behavior questionnaire and&#xD;
&#xD;
        -  score of caregiver impact and burden&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 17, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Defecation frequency per week</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week</time_frame>
    <description>Defecation frequency per week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal incontinence frequency per week</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week.</time_frame>
    <description>Fecal incontinence frequency per week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall treatment success after 4 weeks of treatment</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week</time_frame>
    <description>Treatment success was defined as bowel movements ≥ 3 times per week and fecal incontinence ≤ once per 2 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of abdominal pain and painful defecation</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week.</time_frame>
    <description>Abdominal pain and painful defecation based on the bowel diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pictorial scale of pain intensity</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week.</time_frame>
    <description>The children's subjective level of pain during bowel movement in pictorial scale in a range of 0-10.with 0 as no pain and 10 as extremely painful</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week.</time_frame>
    <description>SDQ is a brief emotional and behavioural screening questionnaire for children and young people. The tool can capture the perspective of the parents&#xD;
The 25 items in the SDQ comprise 5 scales of 5 items each. Each item score 0-2. For each of the 5 scales the score can range from 0 to 10 if all items were completed. All subscale except prosocial score added up to total difficulties score&#xD;
Emotional symptoms subscale&#xD;
Conduct problems subscale&#xD;
Hyperactivity/inattention subscale&#xD;
Peer relationships problem subscale&#xD;
Prosocial behaviour subscale&#xD;
For parent completed SDQ Total difficulties score Normal 0-13 Borderline 14-16 Abnormal 17-40 Emotional problems score Normal 0-3 Borderline 4 Abnormal 5-10 Conduct problems score Normal 0-2 Borderline 3 Abnormal 4-10 Hyperactivity score Normal 0-5 Borderline 6 Abnormal 7-10 Peer problems score Normal 0-2 Borderline 3 Abnormal 4-10 Prosocial score Normal 6-10 Borderline 5 Abnormal 0-4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Care-giver's perceived stress level in visual analogue scale</measure>
    <time_frame>baseline, change from baseline at 4th week; change from baseline at 8th week.</time_frame>
    <description>Score of care-giver's perceived stress level based on visual analogue scale in a range of 0-10, with 0 as no stress and 10 as very stressful</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Tuina (massage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tuina is massage based on Traditional Chinese Medicine (TCM) principles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of patients will receive Tuina (massage) 4 weeks after baseline assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tuina (massage)</intervention_name>
    <description>Tuina is massage based on Traditional Chinese Medicine (TCM) principles.</description>
    <arm_group_label>Tuina (massage)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a. Pre-school age children: Age 2-6 b. Gender: male or female c. Suffered from&#xD;
             functional constipation (base on Rome IV criteria) d. Currently receiving&#xD;
             rehabilitation service in the pediatric service unit run by Yan Chai Hospital Social&#xD;
             Service Department (e.g. Early Education and Training Centre (EETC), Special Child&#xD;
             Care Centre (SCCC), On site Pre-school Rehabilitation Service team.) e. The caregiver&#xD;
             of the child is committed to participate in the research activities, include:&#xD;
&#xD;
          -  bringing the child to attend the treatment sessions and present during the treatment&#xD;
&#xD;
          -  observing and recording the constipation related symptom of the child during the study&#xD;
             period and respond on the outcome measurement tools.&#xD;
&#xD;
        (The caregiver is preferred to be a family member, but could also be a child-care provider&#xD;
        who live with the study subject.) f. The legal guardian of the study subject, and the&#xD;
        caregiver both sign the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children in the following situation will be excluded from the study:&#xD;
&#xD;
               1. who has contra-indication of massage&#xD;
&#xD;
               2. who is currently receiving massage as a regular therapy&#xD;
&#xD;
               3. who is known to suffer from any physical (anatomical) or physiological (hormonal&#xD;
                  or other body chemistry) cause that leads to constipation symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Chinese Medicine, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Paediatric Massage, Constipation, Pre-school Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT03751267
org study id: UW18-132
nct id: NCT03751267
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The research is a collaborative project by HKU and Yan Chai Hospital, funded by Social
      Welfare Development Fund of HKSAR. The study is designed as a prospective randomized control
      trial with the primary objective to investigate the efficacy of pediatric tuina (massage) on
      the functional constipation of pre-school aged children.

      Our study is a pragmatic research comparing the pediatrictuina(massage)treatment with care as
      usual, with the objectives of investigating

        1. if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the
           constipation and related symptoms experienced by the pre-school age children

        2. if there is a positive impact on the caregiver-children relationship and the children's
           behaviour (a sub-group analysis) when the constipation symptoms improved.

      The subjects of this study are pre-school age children (age 2-6) who are serviced by Yan Chai
      Hospital Social Service Department (YCHSS).The subjects will be openly recruited through the
      service units serving pre-school aged children under YCHSS. Rome IV criteria will be used to
      identify the children who suffer from constipation.

      I. Trial Design This is a multicentre, pragmatic randomized control trial (PRCT) with a
      prospective design

      Hypothesis 1:

      Applying regular pediatrictuina (massage) (3 times a week, for 4 weeks ) on pre-school aged
      children with functional constipation will improve one or more of the following symptoms.

        -  Frequency of defecations

        -  Episode of incontinence

        -  Excessive stool retention

        -  Painful or hard bowel movements

        -  Presence of a large fecal mass in the rectum that may obstruct the toilet

      Hypothesis 2:

      The stress level of the caregiver of the study subjects improve as the constipation syndrome
      of the subjects improve.

      Hypothesis 3:

      The children with behavior problem who suffered from constipation will have less behavior
      issue when their functional constipation syndromes improved

      Total 160 pre-school aged children with functional constipation and their caregiver will be
      openly recruited from the institutions/service units operated by the pediatric service unit
      of Yan Chai Hospital Social Service Department.The recruited children must suffer from
      functional constipation symptoms (based on Rome IV criteria). All accepted subjects will be
      in dyad. (i.e. 1 pre-school aged child and his designated caregiver, who commits bring the
      child to attend all treatment and assessment sessions, respond to all caregivers' assessment
      and fill in the daily logbook).

      All applications will be screened by the social workers in the centres based on the inclusion
      and exclusion criteria. Qualified applicants will be invited for a health assessment
      conducted by registered TCM practitioner in the research team to confirm their suitability
      and invite them to sign the consent form. The consented dyad will be allocated randomly into
      treatment group and waitlist control group.

      II. Intervention A 10 minutes structured pediatric massage protocol with specific
      applications technique will be performed on the children allocated to the treatment group
      three times a week for 4 consecutive weeks by trained TCM practitioners in the service units
      of YCHSS. The caregivers of the children need to participate in all assessment sessions and
      fill in the log book provided.

      In the 1st 4 weeks, the children in the waitlist control group will not receive any
      pediatrictuina (massage). After the dyad completed the assessment sessions at baseline and
      week 4 ,(served as Treatment-as-Usual Control), children in the control group will receive
      the same 4 weeks of pediatric massage as the treatment group. The data collected before the
      treatment begins at week 4 will serve as the 2nd baseline for the waitlist control group.

      The treatment protocol involve 8 steps.The massage area focuses on the abdomen and lower back
      of the recipients. All the movements/steps selected are well established and commonly used in
      the TCM practices. Any movement that demand professional training or involve potential risk
      is excluded from the protocol.

      III. Measurement of efficacy Efficacy of the treatments will be measured in multi dimensions
      before and after the treatment for both groups. The main outcome measures are defecation
      frequency per week, fecal incontinence frequency per week, and overall treatment success
      after 4 weeks intervention, 8 weeks intervention and 12 weeks (4 weeks after intervention
      stopped) Secondary outcome measures included

        -  abdominal pain and painful defecation based on bowel diary,

        -  the children's subjective level of pain during bowel movement,

        -  score of child behavior questionnaire and

        -  score of caregiver impact and burden
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Defecation frequency per week
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week
description: Defecation frequency per week
measure: Fecal incontinence frequency per week
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
description: Fecal incontinence frequency per week
measure: Overall treatment success after 4 weeks of treatment
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week
description: Treatment success was defined as bowel movements ≥ 3 times per week and fecal incontinence ≤ once per 2 weeks.
measure: Frequency of abdominal pain and painful defecation
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
description: Abdominal pain and painful defecation based on the bowel diary
measure: Pictorial scale of pain intensity
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
description: The children's subjective level of pain during bowel movement in pictorial scale in a range of 0-10.with 0 as no pain and 10 as extremely painful
measure: Strengths and Difficulties Questionnaire (SDQ)
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
description: SDQ is a brief emotional and behavioural screening questionnaire for children and young people. The tool can capture the perspective of the parents
The 25 items in the SDQ comprise 5 scales of 5 items each. Each item score 0-2. For each of the 5 scales the score can range from 0 to 10 if all items were completed. All subscale except prosocial score added up to total difficulties score
Emotional symptoms subscale
Conduct problems subscale
Hyperactivity/inattention subscale
Peer relationships problem subscale
Prosocial behaviour subscale
For parent completed SDQ Total difficulties score Normal 0-13 Borderline 14-16 Abnormal 17-40 Emotional problems score Normal 0-3 Borderline 4 Abnormal 5-10 Conduct problems score Normal 0-2 Borderline 3 Abnormal 4-10 Hyperactivity score Normal 0-5 Borderline 6 Abnormal 7-10 Peer problems score Normal 0-2 Borderline 3 Abnormal 4-10 Prosocial score Normal 6-10 Borderline 5 Abnormal 0-4
measure: Care-giver's perceived stress level in visual analogue scale
time frame: baseline, change from baseline at 4th week; change from baseline at 8th week.
description: Score of care-giver's perceived stress level based on visual analogue scale in a range of 0-10, with 0 as no stress and 10 as very stressful
arm group label: Tuina (massage)
arm group type: Experimental
description: Tuina is massage based on Traditional Chinese Medicine (TCM) principles.
arm group label: Wait-list control
arm group type: No Intervention
description: This group of patients will receive Tuina (massage) 4 weeks after baseline assessments.
intervention type: Procedure
intervention name: Tuina (massage)
description: Tuina is massage based on Traditional Chinese Medicine (TCM) principles.
arm group label: Tuina (massage)
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Lei Li
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: No