<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/NCT03764995</url>
  </required_header>
  <id_info>
    <org_study_id>2018-261/2018-32</org_study_id>
    <nct_id>NCT03764995</nct_id>
  </id_info>
  <brief_title>The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation</brief_title>
  <official_title>The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      The aim of the present study is to investigate the efficacy of abdominal massage in patients&#xD;
      with functional (primary) chronic constipation. The present study is designed as a randomized&#xD;
      placebo controlled. Since the placebo group is included in the research design, if there is a&#xD;
      greater improvement of symptoms of constipation and quality of life in the massage group when&#xD;
      compared to the control group, it will be determined that this effect is not related to a&#xD;
      placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled&#xD;
      design, the therapist effect will be eliminated and further evidence on a well-known massage&#xD;
      technique in functional (primary) chronic constipation, a common gastrointestinal problem,&#xD;
      will be provided. The results of the present placebo controlled randomized trial will&#xD;
      indicate that the need for pharmacological agents and the side effects associated with these&#xD;
      agents will be reduced. According to the literature, there are studies that investigate the&#xD;
      effects of abdominal massage on symptoms of constipation and quality of life. However, it has&#xD;
      generally been used for secondary constipation or two applications have been compared. In&#xD;
      addition, there is no randomized placebo-controlled study investigating the effect of&#xD;
      abdominal massage on severity of chronic constipation and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Constipation is a subjective symptom that defines as inadequate defecation including several&#xD;
      symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and&#xD;
      difficulty in defecation. The general prevalence of constipation in adults is 16%. The&#xD;
      pre-defined risk factors are women gender, advanced age, non-white ethnicity, low&#xD;
      socio-economic level, decreased physical activity underlying diseases, and medications.&#xD;
      Chronic constipation affects quality of life and causes problems such as anxiety, depression,&#xD;
      somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following&#xD;
      periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux,&#xD;
      hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.&#xD;
&#xD;
      In the treatment of chronic constipation, conservative approaches (lifestyle change and&#xD;
      physiotherapy applications) are used at the first phase. If conservative approaches are not&#xD;
      helpful for patients pharmacological and surgical treatment can be performed based on the&#xD;
      characteristics of patients, respectively. Pharmacological treatments aim to increase the&#xD;
      frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to&#xD;
      improve stool consistency. However, side effects such as abdominal bloating, abdominal&#xD;
      cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by&#xD;
      patients in the following period. Furthermore, medications for constipation management are&#xD;
      not cost-effective. Therefore, the level of evidence on conservative approaches with low&#xD;
      cost, non-invasive and no-side effects in constipation treatment should be increased.&#xD;
&#xD;
      Physiotherapy approaches to alleviate chronic constipation symptoms include such as&#xD;
      defecation training, abdominal massage, connective tissue massage, electrical stimulation,&#xD;
      Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application&#xD;
      in constipation is used in constipation management since the early 1870s and it is popular in&#xD;
      recent years. The benefits of abdominal massage are known as follows: reduction in the&#xD;
      abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic&#xD;
      movements. The technique of abdominal massage consists of 5 stages as follows: abdominal&#xD;
      muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle&#xD;
      stroking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of constipation</measure>
    <time_frame>Change in severity of constipation from baseline at 4 weeks</time_frame>
    <description>Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Constipation Quality of life</measure>
    <time_frame>Change in quality of life from baseline at 4 weeks</time_frame>
    <description>Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. This questionnaire includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>Change from baseline stool consistency at 4 weeks</time_frame>
    <description>The stool consistency will be evaluated using the Bristol Stool Scale (BSS), quick and useful indicator of the colonic transit time , a seven-point scale (from 1 to 7), type 1=separate hard lumps, like nuts; 2=sausage shaped but lumpy; 3=like a sausage or snake, but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges; 6=pieces with ragged edges, a mushy stool; 7=water, no solid pieces. While type 1 and 2 indicate hard stool, type 3,4 and 5 show looser (ideal) stool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of constipation</measure>
    <time_frame>Change from baseline symptoms of constipation at 4 weeks</time_frame>
    <description>In order to gather information regarding the participants' symptoms of constipation, they will be asked to complete a 7-day bowel diary during the treatment period. This diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, feeling of incomplete evacuation, and changes in food and liquid consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal pain, abdominal bloating severity and the effect of life</measure>
    <time_frame>Change from baseline symptoms of constipation at 4 weeks</time_frame>
    <description>Visual Analogue Scale (VAS): This scale is a 10 cm horizontal line. 0 = no pain / bloating / meaning no effect, 10 = unbearable pain / bloating / experiencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>Change from baseline symptoms of constipation at 4 weeks</time_frame>
    <description>The physical activity levels of the individuals in the last seven days are evaluated under 4 headings (severe activities, moderate activity, walking and sitting). While calculating the total score, the MET-min scores of the patients are obtained by multiplying the duration of activity and frequency of activities (number of days) by the BAT values given to activities (severe activity = 8 MET, moderate activity = 4 MET, walking = 3.3 MET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient global change scale</measure>
    <time_frame>Change from baseline patient global change at 4 weeks</time_frame>
    <description>It is a 7-item scale that evaluates the perception of the change in the effect of constipation and related complaints on the life of the patient compared to the study. The options on this scale are ''much much better'', ''much better'', 'a little better'', ''no change&quot;, ''a little worse'', ''much worse'', ''much much worse''</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Abdominal Massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Ultrasound</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard bowel management</intervention_name>
    <description>Lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.</description>
    <arm_group_label>Abdominal Massage</arm_group_label>
    <arm_group_label>Placebo Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abdominal massage</intervention_name>
    <description>Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.</description>
    <arm_group_label>Abdominal Massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Ultrasound</intervention_name>
    <description>Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.</description>
    <arm_group_label>Placebo Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 65 years.&#xD;
&#xD;
          -  Diagnosed with chronic constipation according to Rome IV criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A recent history of abdominal surgery&#xD;
&#xD;
          -  Intestinal obstruction, ileus, colon cancer&#xD;
&#xD;
          -  Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease,&#xD;
             Megacolon, Megarectum&#xD;
&#xD;
          -  Umbilical hernia&#xD;
&#xD;
          -  Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease,&#xD;
             Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm&#xD;
&#xD;
          -  Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis,&#xD;
             Cerebro-vascular event,&#xD;
&#xD;
          -  Paraplegia Mental problem to prevent co-operative treatment&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ceren Gursen</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.</citation>
    <PMID>19217105</PMID>
  </reference>
  <reference>
    <citation>Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.</citation>
    <PMID>21943617</PMID>
  </reference>
  <reference>
    <citation>Lamas K, Graneheim UH, Jacobsson C. Experiences of abdominal massage for constipation. J Clin Nurs. 2012 Mar;21(5-6):757-65. doi: 10.1111/j.1365-2702.2011.03946.x. Epub 2011 Nov 21.</citation>
    <PMID>22098585</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SERAP ÖZGÜL</investigator_full_name>
    <investigator_title>Doc. Dr.</investigator_title>
  </responsible_party>
  <keyword>massage</keyword>
  <keyword>abdominal massage</keyword>
  <keyword>chronic constipation</keyword>
  <keyword>primary constipation</keyword>
  <keyword>functional constipation</keyword>
  <keyword>defecation</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/NCT03764995
org study id: 2018-261/2018-32
nct id: NCT03764995
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to investigate the efficacy of abdominal massage in patients
      with functional (primary) chronic constipation. The present study is designed as a randomized
      placebo controlled. Since the placebo group is included in the research design, if there is a
      greater improvement of symptoms of constipation and quality of life in the massage group when
      compared to the control group, it will be determined that this effect is not related to a
      placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled
      design, the therapist effect will be eliminated and further evidence on a well-known massage
      technique in functional (primary) chronic constipation, a common gastrointestinal problem,
      will be provided. The results of the present placebo controlled randomized trial will
      indicate that the need for pharmacological agents and the side effects associated with these
      agents will be reduced. According to the literature, there are studies that investigate the
      effects of abdominal massage on symptoms of constipation and quality of life. However, it has
      generally been used for secondary constipation or two applications have been compared. In
      addition, there is no randomized placebo-controlled study investigating the effect of
      abdominal massage on severity of chronic constipation and quality of life.
Constipation is a subjective symptom that defines as inadequate defecation including several
      symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and
      difficulty in defecation. The general prevalence of constipation in adults is 16%. The
      pre-defined risk factors are women gender, advanced age, non-white ethnicity, low
      socio-economic level, decreased physical activity underlying diseases, and medications.
      Chronic constipation affects quality of life and causes problems such as anxiety, depression,
      somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following
      periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux,
      hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.

      In the treatment of chronic constipation, conservative approaches (lifestyle change and
      physiotherapy applications) are used at the first phase. If conservative approaches are not
      helpful for patients pharmacological and surgical treatment can be performed based on the
      characteristics of patients, respectively. Pharmacological treatments aim to increase the
      frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to
      improve stool consistency. However, side effects such as abdominal bloating, abdominal
      cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by
      patients in the following period. Furthermore, medications for constipation management are
      not cost-effective. Therefore, the level of evidence on conservative approaches with low
      cost, non-invasive and no-side effects in constipation treatment should be increased.

      Physiotherapy approaches to alleviate chronic constipation symptoms include such as
      defecation training, abdominal massage, connective tissue massage, electrical stimulation,
      Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application
      in constipation is used in constipation management since the early 1870s and it is popular in
      recent years. The benefits of abdominal massage are known as follows: reduction in the
      abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic
      movements. The technique of abdominal massage consists of 5 stages as follows: abdominal
      muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle
      stroking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Severity of constipation
time frame: Change in severity of constipation from baseline at 4 weeks
description: Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
measure: Patient Assessment of Constipation Quality of life
time frame: Change in quality of life from baseline at 4 weeks
description: Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. This questionnaire includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
measure: Stool consistency
time frame: Change from baseline stool consistency at 4 weeks
description: The stool consistency will be evaluated using the Bristol Stool Scale (BSS), quick and useful indicator of the colonic transit time , a seven-point scale (from 1 to 7), type 1=separate hard lumps, like nuts; 2=sausage shaped but lumpy; 3=like a sausage or snake, but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges; 6=pieces with ragged edges, a mushy stool; 7=water, no solid pieces. While type 1 and 2 indicate hard stool, type 3,4 and 5 show looser (ideal) stool.
measure: Symptoms of constipation
time frame: Change from baseline symptoms of constipation at 4 weeks
description: In order to gather information regarding the participants' symptoms of constipation, they will be asked to complete a 7-day bowel diary during the treatment period. This diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, feeling of incomplete evacuation, and changes in food and liquid consumption.
measure: Abdominal pain, abdominal bloating severity and the effect of life
time frame: Change from baseline symptoms of constipation at 4 weeks
description: Visual Analogue Scale (VAS): This scale is a 10 cm horizontal line. 0 = no pain / bloating / meaning no effect, 10 = unbearable pain / bloating / experiencing
measure: Physical activity levels
time frame: Change from baseline symptoms of constipation at 4 weeks
description: The physical activity levels of the individuals in the last seven days are evaluated under 4 headings (severe activities, moderate activity, walking and sitting). While calculating the total score, the MET-min scores of the patients are obtained by multiplying the duration of activity and frequency of activities (number of days) by the BAT values given to activities (severe activity = 8 MET, moderate activity = 4 MET, walking = 3.3 MET)
measure: Patient global change scale
time frame: Change from baseline patient global change at 4 weeks
description: It is a 7-item scale that evaluates the perception of the change in the effect of constipation and related complaints on the life of the patient compared to the study. The options on this scale are ''much much better'', ''much better'', 'a little better'', ''no change", ''a little worse'', ''much worse'', ''much much worse''
arm group label: Abdominal Massage
arm group type: Experimental
arm group label: Placebo Ultrasound
arm group type: Placebo Comparator
intervention type: Other
intervention name: Standard bowel management
description: Lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.
arm group label: Abdominal Massage
arm group label: Placebo Ultrasound
intervention type: Other
intervention name: Abdominal massage
description: Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.
arm group label: Abdominal Massage
intervention type: Other
intervention name: Placebo Ultrasound
description: Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.
arm group label: Placebo Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.
PMID: 19217105
citation: Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
PMID: 21943617
citation: Lamas K, Graneheim UH, Jacobsson C. Experiences of abdominal massage for constipation. J Clin Nurs. 2012 Mar;21(5-6):757-65. doi: 10.1111/j.1365-2702.2011.03946.x. Epub 2011 Nov 21.
PMID: 22098585
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SERAP ÖZGÜL
investigator title: Doc. Dr.
mesh term: Constipation
sharing ipd: No