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Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: A Randomized Controlled Trial

Primary Purpose

Spinal Cord Injuries, Traditional Chinese Medicine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Caregiver-led, acupressure combined with nursing intervention
Caregiver-led, sham acupressure combined with nursing intervention
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injury, Acupressure, Community-dwelling, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hong Kong residents between the ages of 18 and 64;
  • have willingness and ability to perform acupressure;
  • whose constipation diagnosed according to international Rome III diagnostic criteria: Symptoms must include 2 or more of the following: ① at least one - quarter of bowel movements are strained; ② at least one-quarter of bowel movements are dry balls or hard stools; ③ at least one-quarter of bowel movements Feeling of incomplete defecation; ④ At least one-fourth of the bowel movements have a sense of anorectal obstruction or obstruction; 3 times / week .
  • loose stool rarely occur when laxatives are not used;
  • there are insufficient evidence to diagnose irritable bowel syndrome (IBS).

Above symptoms have been present for at least 6 months before diagnosis. And these symptoms have meet the diagnostic criteria in the past three months.

Exclusion Criteria:

  • live alone in the community without caregivers or family members;
  • patients who have diagnosed by Chinese medicine physicians as unsuitable for acupressure;
  • participating in other TCM treatments or defecation or bowel-related interventions;
  • caregivers are unable to attend the training due to subjective reasons or cognitive or psychiatric impairments;
  • had lesions in the intestine in the past;
  • could not complete the treatment and evaluation due to functional insufficiency of the liver, kidney, heart and other organs, or other spinal cord injury;
  • whose cognitive and mental conditions are unable to cooperate with the therapist.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group: caregiver-led sham group , acupressure combined with nursing interventions

    Arm Description

    The intervention group will receive acupressure, and then they will receive nursing intervention.

    The control group will receive sham acupressure as a placebo and then they will receive nursing intervention.

    Outcomes

    Primary Outcome Measures

    The severity of constipation at pre-test
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    The severity of constipation at 10 days follow up
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    The severity of constipation at one month follow up
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    The quality of life at pre-test
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.
    The quality of life at 10 days follow up
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.
    The quality of life at one month follow up
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    September 25, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05558657
    Brief Title
    Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: A Randomized Controlled Trial
    Official Title
    Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. Chinese medicine, acupuncture and acupressure are the treatments of constipation in Traditional Chinese Medicine. Acupressure is a non- invasive intervention which is easy to learn and apply. We have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. And this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.
    Detailed Description
    This study will use a double-blind, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. Study participants will be recruited from the "Hong Kong Direction Association for the Handicapped, a non-governmental organization dedicated to serving severely disabled Hong Kong people such as SCI. The sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. Research assistants (RA1) were trained to evaluate data and data, blinded to group assignments. We will have the focus group interviews (semi-structured) with caregivers after the second post-intervention assessment of study subjects (after 1-month follow-up). Eight caregivers will participate in interviews, which will be conducted online, to further understand the benefits and limitations of the research intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Traditional Chinese Medicine
    Keywords
    Spinal cord injury, Acupressure, Community-dwelling, Traditional Chinese Medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    We aim to have two study group, including the intervention group that receive acupressure combined with nursing interventions, and the control group that receive acupressure on sham acupoints combined with nursing interventions
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention group will receive acupressure, and then they will receive nursing intervention.
    Arm Title
    Control group: caregiver-led sham group , acupressure combined with nursing interventions
    Arm Type
    Active Comparator
    Arm Description
    The control group will receive sham acupressure as a placebo and then they will receive nursing intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Caregiver-led, acupressure combined with nursing intervention
    Intervention Description
    The intervention group will focus on the Hegu, Zusanli, Tianshu and Zhongwan acupoints. The caregivers can perform acupressure two hours after meals and once a day. And they can first perform acupressure on Zhongwan acupoints, and then Tianshu points on right and left abdomen. And then press Quchi point on the right and left arm. They can use the plan of the hand to massage clockwise on the position which is two inches from the navel for 8 minutes. Besides, the intervention group will also receive nursing interventions on the basis of receiving acupressure intervention including (1) dietary guidance: help patients to formulate a reasonable diet plan, (2) cultivate regular defecation in patients, ( 3 ) Moderate exercise to increase gastrointestinal motility.
    Intervention Type
    Other
    Intervention Name(s)
    Caregiver-led, sham acupressure combined with nursing intervention
    Intervention Description
    Control group will receive sham acupressure once a day for 10 days. Sham acupressure is the only difference compare with the intervention group. We will train the caregivers to perform acupressure on Tibia next to Zusanli, the lateral epicondyle of the humerus next to Quchi, the radius next to the tributary groove and last the second metacarpal next to Hegu. Also, they can do massage to the abdomen for 8 minutes. And they use same force as the intervention group.
    Primary Outcome Measure Information:
    Title
    The severity of constipation at pre-test
    Description
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    Time Frame
    The severity of constipation will be assessed at pre-intervention.
    Title
    The severity of constipation at 10 days follow up
    Description
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    Time Frame
    The severity of constipation will be assessed after 10 days follow-up.
    Title
    The severity of constipation at one month follow up
    Description
    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation in mentally illness patients, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
    Time Frame
    The severity of constipation will be assessed after one month follow-up.
    Title
    The quality of life at pre-test
    Description
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.
    Time Frame
    The quality of life will be assessed will be assessed at pre-intervention
    Title
    The quality of life at 10 days follow up
    Description
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.
    Time Frame
    The quality of life will be assessed will be assessed after 10 days follow-up.
    Title
    The quality of life at one month follow up
    Description
    Constipation-related Quality of Life Questionnaire will be used to measure the concerns of constipation-related patients, the degree of physical and mental discomfort, and the overall feeling of constipation, 0 indicated none of time or not at all, 4 indicated all of the time or extremly. Scores will be vary from 0 to 4 with lower scores indicating better health-related Quality of Life.
    Time Frame
    The quality of life will be assessed after one month follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hong Kong residents between the ages of 18 and 64; have willingness and ability to perform acupressure; whose constipation diagnosed according to international Rome III diagnostic criteria: Symptoms must include 2 or more of the following: ① at least one - quarter of bowel movements are strained; ② at least one-quarter of bowel movements are dry balls or hard stools; ③ at least one-quarter of bowel movements Feeling of incomplete defecation; ④ At least one-fourth of the bowel movements have a sense of anorectal obstruction or obstruction; 3 times / week . loose stool rarely occur when laxatives are not used; there are insufficient evidence to diagnose irritable bowel syndrome (IBS). Above symptoms have been present for at least 6 months before diagnosis. And these symptoms have meet the diagnostic criteria in the past three months. Exclusion Criteria: live alone in the community without caregivers or family members; patients who have diagnosed by Chinese medicine physicians as unsuitable for acupressure; participating in other TCM treatments or defecation or bowel-related interventions; caregivers are unable to attend the training due to subjective reasons or cognitive or psychiatric impairments; had lesions in the intestine in the past; could not complete the treatment and evaluation due to functional insufficiency of the liver, kidney, heart and other organs, or other spinal cord injury; whose cognitive and mental conditions are unable to cooperate with the therapist.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Li, Dr
    Phone
    2766 6388
    Email
    yan-nursing.li@polyu.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tsz Ching Sun, Miss
    Phone
    3400 3911
    Email
    tszching.sun@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Li, Dr
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: A Randomized Controlled Trial

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