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NCT Number: NCT07751224

Auricular Acupuncture for Post-Stroke Constipation

The goal of this clinical trial is to learn if auricular acupuncture can improve constipation in hospitalized patients with post-stroke constipation. It will also evaluate whether auricular acupuncture is safe when used together with standard care.

The main questions it aims to answer are:

* Does auricular acupuncture reduce constipation severity in patients with post-stroke constipation? * Does auricular acupuncture intestinal symptoms compared with sham auricular acupuncture? * Is auricular acupuncture safe for patients with post-stroke constipation? Researchers will compare auricular acupuncture plus standard care with sham auricular acupuncture plus standard care to determine whether auricular acupuncture provides additional benefits in relieving constipation symptoms.

Participants will:

* Be randomly assigned to receive either auricular acupuncture or sham auricular acupuncture * Receive one treatment session daily for 8 consecutive treatment days in addition to standard care. * Complete assessment of constipation severity and intestinal symptoms before and during the study. * Be monitored for any adverse events throughout the study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ho Chi Minh City Hospital of Orthpaedics and Rehabilitation

Ho Chi Minh City, Vietnam

About this study

Post-stroke constipation (PSC) is one of the most common gastrointestinal complications after stroke and is associated with prolonged hospitalization, impaired rehabilitation, reduced quality of life, and poorer functional outcomes. Conventional management, including laxatives, dietary modification, and bowel training, may improve constipation symptoms; however, many patients continue to experience persistent bowel dysfunction despite these treatments. Therefore, safe and effective adjunctive therapies are needed to optimize bowel management during stroke rehabilitation.

Auricular acupuncture is a non-pharmacological intervention that has been increasingly used to manage gastrointestinal disorders. Previous experimental and clinical studies suggest that stimulation of specific auricular acupoints may regulate autonomic nervous system activity, improve gastrointestinal motility, and modulate the gut-brain axis. Although several studies have reported beneficial effects of auricular acupuncture for constipation, evidence regarding its effectiveness in patients with post-stroke constipation remains limited, particularly from randomized sham-controlled clinical trials.

This study was conducted to evaluate the effectiveness and safety of auricular acupuncture as an adjunct to standard care in hospitalized patients with post-stroke constipation. Participants were randomly assigned to receive either auricular acupuncture plus standard care or sham auricular acupuncture plus standard care. Constipation severity, intestinal symptoms, bowel function, and adverse events were evaluated during the intervention period to compare the therapeutic effects between the two groups.

The findings of this study are expected to provide additional clinical evidence regarding the role of auricular acupuncture as an adjunctive treatment for post-stroke constipation and may contribute to the development of evidence-based rehabilitation strategies for patients recovering from stroke.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older.
  • Hospitalized patients with stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Glasgow Coma Scale score >= 14
  • Diagnosed with constipation according to the Constipation Assessment Scale (CAS) with a score > 2 and constipation duration of less than 1 week
  • No history of gastrointestinal study
  • Receiving routine rehabilitation therapy, including body acupuncture, massage therapy, and physical rehabilitation according to the hospital protocol
  • Able to provide written informed consent

Exclusion criteria

  • Inability to cooperate with study procedures because of cognitive impairment, psychiatric disorders, or severe communication difficulties after stroke.
  • Skin lesions or infection involving the auricle.
  • Pregnancy.
  • Acute illness, exacerbation of chronic disease, malignant tumors, cancer, or severe dermatological disorders.
  • Current use of medications known to cause constipation, including antidepressants, opioid analgesics, iron supplements, calcium channel blockers, or antacids.

Treatment and study plan

Auricular acupuncture

Procedure

Auricular acupuncture was performed at six therapeutic auricular acupoints (AH6a, HX2, TF3, CO7, CO17, and CO14) on the left ear. Needles were manually stimulated for 30 seconds every 5 minutes during each 20-minute treatment session. Treatment was administered once daily, five sessions per week, for eight treatment days.

Sham auricular acupuncture

Procedure

Sham auricular acupuncture was performed at six non-therapeutic auricular points (SF1, SF2, SF3, AH1, AH2, and AH3) using the same needle manipulation, treatment duration, and treatment schedule as the experimental intervention.

Primary outcomes

  1. Constipation Assessment Scale (CAS) score

    Time frame: Baseline and Days 1, 3, 5, and 8 after treatment initiation

    The Constipation Assessment Scale (CAS) is an 8-item validated instrument used to assess the severity of constipation. Total scores range from 0 to 16, with higher scores indicating more severe constipation.

Secondary outcomes

  1. Intestinal Symptom Score

    Time frame: Baseline and Days 1, 3, 5, and 8 after treatment initiation

    Intestinal symptoms were assessed using the Ten-Item Intestinal Symptoms Rating Scale. Higher score indicate more severe intestinal symptom

  2. Adverse events

    Time frame: Throughout the 8-day intervention periof

    Incidence of adverse events related to study interventions

Sponsors and collaborators

Lead sponsor

Ho Chi Minh City Orthopedics and Rehabilitation Hospital

Other

Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Registry information

Official study title

Effectiveness of Auricular Acupuncture for Post-Stroke Constipation: A Randomized Sham-Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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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