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

NCT ID: NCT05558657

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-09-30

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 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.

Conditions

Spinal Cord Injuries; Traditional Chinese Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The intervention group will receive home-based acupressure and nursing education.

Group Type: EXPERIMENTAL

Home-based, acupressure combined with nursing education

Intervention Type: 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.

Control group: Home-based sham group , acupressure combined with nursing interventions

The control group will receive home-based, manual light touch of the abdomen combined with nursing education.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

Home-based, acupressure combined with nursing education

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.

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. being Hong Kong residents between the ages of 18 or older,

2. having an SCI diagnosis for over 6 months and living in the community,

3. demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),

4. experiencing difficulties with defecation or having concerns related to defecation.

Exclusion Criteria

1. currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,

2. being unable to attend the training sessions due to personal reasons,

3. having a history of gastrointestinal organic disease,

4. having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Li, Dr

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic Unviersity

Hong Kong, , Hong Kong

Countries

Hong Kong

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Other Identifiers

P0035107

Identifier Type: -

Identifier Source: org_study_id