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

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Traditional Chinese Medicine
Spinal Cord Injuries

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05558657
P0035107

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention group will receive home-based acupressure and nursing education.
Treatment:
Other: Home-based, acupressure combined with nursing education
Control group: Home-based sham group , acupressure combined with nursing interventions
Active Comparator group
Description:
The control group will receive home-based, manual light touch of the abdomen combined with nursing education.
Treatment:
Other: Home-based, manual light touch of the abdomen combined with nursing education

Trial contacts and locations

1

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Central trial contact

Yan Li, Dr; Tsz Ching Sun, Miss

Data sourced from clinicaltrials.gov

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