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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injuries, Traditional Chinese Medicine

Intervention / Treatment
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* Other: Caregiver-led, acupressure combined with nursing intervention
* Other: Caregiver-led, sham acupressure combined with nursing intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group will receive acupressure, and then they will receive nursing intervention. | Other: Caregiver-led, acupressure combined with nursing intervention<br>* 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.<br>|
| Active Comparator: Control group: caregiver-led sham group , acupressure combined with nursing interventions<br>The control group will receive sham acupressure as a placebo and then they will receive nursing intervention. | Other: Caregiver-led, sham acupressure combined with nursing intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 will be assessed at pre-intervention. | 
| 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 will be assessed after 10 days follow-up. | 
| 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 severity of constipation will be assessed after one month follow-up. | 
| 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 will be assessed will be assessed at pre-intervention | 
| 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 will be assessed will be assessed after 10 days follow-up. | 
| 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. | The quality of life will be assessed after one month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Acupressure, Community-dwelling, Traditional Chinese Medicine