Constipation, Stroke, Post-stroke Constipation
Conditions
Keywords
Auricular Acupuncture, Post-Stroke Constipation, Stroke Rehabilitation, Constipation, Randomized Controlled Trial, Sham-Controlled Trial, Complementary Therapy, Traditional Medicine
Brief summary
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.
Detailed description
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.
Interventions
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 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.
Sponsors
Study design
Masking description
Participants were blinded to treatment allocation. Both auricular acupuncture and sham auricular acupuncture were administered using identical procedures and treatment schedules to minimize participants' awareness of group assignment. The acupuncturist providing the intervention was not blinded because of the nature of the treatment.
Intervention model description
Interventional Study Model
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constipation Assessment Scale (CAS) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Symptom Score | 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 |
| Adverse events | Throughout the 8-day intervention periof | Incidence of adverse events related to study interventions |
Countries
Vietnam