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NCT Number: NCT05558657

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Traditional Chinese Medicine Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic Unviersity

Hong Kong

About this study

This study will use an open-label, 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 participants after the the intervention (post-intervention). The interviews will be conducted online to further understand the benefits and limitations of the research intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being Hong Kong residents between the ages of 18 or older,
  • having an SCI diagnosis for over 6 months and living in the community,
  • demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),
  • experiencing difficulties with defecation or having concerns related to defecation.

Exclusion criteria

  • currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,
  • being unable to attend the training sessions due to personal reasons,
  • having a history of gastrointestinal organic disease,
  • having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses

Treatment and study plan

Home-based, acupressure combined with nursing education

Other

The intervention group will focus on 11 acupoints on the abdomen (RN12, RN4, ST25), back (BL20, BL21, BL22, BL23, BL24, BL25), and limbs (LI4, ST36). The participants or their caregivers can perform acupressure 30 minutes after meals and twice a day. Participants can choose between two sets of acupressure: (1) Acupressure of the abdominal and back acupoints in a seated position, or (2) Acupressure of the abdominal and limb acupoints in a supine position. Each session lasts approximately 15 minutes.

Besides, the intervention group will also receive nursing education on the basis of receiving acupressure intervention including (1) dietary guidance: help patients to formulate a reasonable diet plan, (2) cultivate regular defecation habits, (3) understand appropriate defecation environments and postures, and (4) Moderate exercise to increase gastrointestinal motility.

Home-based, manual light touch of the abdomen combined with nursing education

Other

Control group or their caregivers will apply the manual light touch to the abdomen in any direction or body position at home. In keeping consistent with the intervention group, abdomen touching will also be administered twice daily for approximately 15 minutes each for 10 days. Participants will also receive nursing education.

Primary outcomes

  1. The severity of constipation at baseline

    Time frame: The severity of constipation will be assessed at baseline assessment.

    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.

  2. The severity of constipation at post-intervention

    Time frame: The severity of constipation will be assessed after 10 days intervention.

    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.

  3. The severity of constipation at one month follow-up

    Time frame: The severity of constipation will be assessed after one month follow-up.

    Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.

Secondary outcomes

  1. Quality of life at baseline

    Time frame: Quality of life will be assessed at baseline assessment.

    The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.

  2. Quality of life at post-intervention

    Time frame: Quality of life will be assessed after 10 days intervention.

    The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.

  3. Quality of life at one month follow-up

    Time frame: Quality of life will be assessed after one month follow-up.

    The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.

  4. Psychosocial well-being at baseline

    Time frame: Psychosocial well-being will be assessed at baseline assessment.

    The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.

  5. Psychosocial well-being at post-intervention

    Time frame: Psychosocial well-being will be assessed after 10 days intervention.

    The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.

  6. Psychosocial well-being at one month follow-up

    Time frame: Psychosocial well-being will be assessed after one month follow-up

    The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.

  7. Bowel habit at baseline

    Time frame: Bowel habit will be assessed at baseline assessment.

    Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.

  8. Bowel habit at post-intervention

    Time frame: Bowel habit will be assessed after 10 days intervention.

    Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.

  9. Bowel habit at one month follow-up

    Time frame: Bowel habit will be assessed after one month follow-up.

    Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effect of Home-based Acupressure on Constipation in People with Spinal Cord Injury: a Study Protocol for a Randomized Controlled Trial with a Mixed-method Approach

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2022
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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