IBS, Constipation Predominant, Anxiety State
Conditions
Brief summary
Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State. This single-center, randomized, single-blinded sham-controlled trial enrolls adults aged 18-70 with constipation-predominant irritable bowel syndrome (IBS-C) and anxiety. All participants receive standardized weekly acupuncture for 4 weeks. Participants are randomly assigned 1:1 to either real daily home Transcutaneous Electrical Acupoint Stimulation(TEAS)at Zusanli acupoint or sham non-acupoint TEAS. The total study period lasts approximately 10 weeks, including 2-week screening, 4-week intervention and 4-week post-treatment follow-up. The primary outcome is weekly complete spontaneous bowel movements (CSBM) at week 4. Secondary outcomes cover anxiety, sleep quality, abdominal symptoms, quality of life and safety. Researchers will test whether adding real home-based TEAS to acupuncture improves bowel and emotional symptoms, and evaluate treatment safety and tolerability.
Detailed description
Constipation-predominant irritable bowel syndrome (IBS-C) is frequently accompanied by anxiety, which exacerbates gastrointestinal symptoms and reduces quality of life. This condition involves complex gut-brain interactions, including autonomic nervous system dysregulation and visceral hypersensitivity. Both acupuncture and Transcutaneous Electrical Acupoint Stimulation (TEAS) have shown potential in regulating gastrointestinal motility and emotional states. However, outpatient acupuncture alone often faces challenges such as interrupted treatment courses. This study aims to evaluate the synergistic effect, safety, and potential autonomic and microbiome mechanisms of combining standardized manual acupuncture with daily home-based TEAS for IBS-C patients with anxiety. Common Acupuncture Treatment (Both Groups): All participants will receive standardized manual acupuncture once a week for 4 weeks. The acupoints include bilateral Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), Taichong (LR3), as well as Baihui (GV20) and Yintang (EX-HN3). Sterile disposable acupuncture needles (0.25×40mm) will be used. The needles will be manipulated to achieve "Deqi" (a sensation of soreness, numbness, distention, or heaviness), and retained for 30 minutes per session. * Experimental Group (Acupuncture + Real TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based real TEAS applied to unilateral Zusanli (ST36). The stimulation parameters will be set at a frequency of 25 Hz, a pulse width of 0.5 ms, and an intermittent mode of 2 seconds on / 3 seconds off. The intensity will be adjusted to the maximum tolerable level that produces a distinct but painless stimulation sensation. * Sham Comparator Group (Acupuncture + Sham TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based sham TEAS. The sham device, electrodes, and operational procedures will be identical in appearance to the real device. However, the stimulation will be applied to a non-acupoint site located 10 cm below and 2-4 cm lateral to ST36 (avoiding major meridians and neurovascular bundles). The intensity will be set to a perceptible surface stimulation, avoiding typical Deqi sensations or muscle contractions.
Interventions
PROCEDUREAcupuncture
Participants receive standardized acupuncture once weekly for 4 weeks.
DEVICETranscutaneous Electrical Acupoint Stimulation
Participants receive daily 1-hour stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli).
Participants receive daily 1-hour sham stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians.
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-70 years, with no restriction on gender. * Meeting the Rome V diagnostic criteria for IBS-C. * Stable constipation phenotype during the screening period; participants are expected to have fewer than 3 CSBMs per week, or be judged by the investigator to present constipation features consistent with IBS-C. * IBS-SSS score ≥ 175, indicating at least moderate IBS symptoms. * HADS-A score ≥ 8, indicating the presence of anxiety status. * Stable regimens of IBS-related medications, anxiolytic/antidepressant agents and other treatments that may affect gastrointestinal motility for at least 2 weeks prior to enrollment; participants are willing to avoid adding relevant new treatments during the study period. * Able to understand study procedures and willing to complete acupuncture treatment, home-based TEA/sham-TEA therapy, symptom diaries and follow-up assessments. * Voluntarily participate in the study and provide written informed consent.
Exclusion criteria
* Presence of organic diseases that could account for symptoms, including inflammatory bowel disease, colorectal neoplasm, intestinal obstruction, coeliac disease, uncontrolled thyroid disease, and diabetic autonomic neuropathy. * Presence of alarm features such as hematochezia, unexplained weight loss, anemia, fever, nocturnal symptoms, and family history of colorectal cancer without completion of necessary diagnostic work-up. * Previous major abdominal surgery that may significantly impair intestinal function. * Severe mental disorders, bipolar disorder, psychotic symptoms, substance dependence, significant suicide risk, or conditions requiring immediate psychiatric intervention. * New initiation or dose adjustment of anxiolytics, antidepressants, antipsychotics, opioids, strong anticholinergic agents, prokinetics, or regular laxatives within 4 weeks prior to screening. * Implanted cardiac pacemaker, implantable cardioverter-defibrillator or other implanted electronic devices, or presence of unstable arrhythmia. * Skin breakdown, infection, severe skin disease at TEA electrode sites, or allergy to electrode materials. * Contraindications to acupuncture, such as severe coagulopathy, inability to tolerate acupuncture, or extremely high risk of acupuncture syncope. * Pregnancy, lactation, or planned pregnancy during the study period. * Participation in another interventional clinical trial within the past 3 months. * Other conditions judged by the investigator to render the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly complete spontaneous bowel movements (CSBM) | Week 4 | The number of complete spontaneous bowel movements recorded in the final observation week of intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score | Baseline, Week 4 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 5 | Baseline, Week 5 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 8 | Baseline, Week 8 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score | Baseline, Week 4 | Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms. |
| Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score at Week 8 | Baseline, Week 8 | Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms. |
| Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) | Baseline, Week 4 | Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress. |
| Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) at Week 8 | Baseline, Week 8 | Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress. |
| Change in Pittsburgh Sleep Quality Index (PSQI) total score | Baseline, Week 4 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality. |
| Change in Pittsburgh Sleep Quality Index (PSQI) total score at Week 8 | Baseline, Week 8 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality. |
| Change in IBS Symptom Severity Scale (IBS-SSS) total score | Baseline, Week 4 | Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms. |
| Change in IBS Symptom Severity Scale (IBS-SSS) total score at Week 8 | Baseline, Week 8 | Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms. |
| Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score | Baseline, Week 4 | Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life. |
| Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score at Week 8 | Baseline, Week 8 | Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life. |
| Weekly complete spontaneous bowel movements (CSBM) at week 5 | Week 5 | The number of complete spontaneous bowel movements recorded during the first week after the end of intervention |
| Weekly complete spontaneous bowel movements (CSBM) at week 8 | Week 8 | The number of complete spontaneous bowel movements recorded during the first week after the end of intervention. |
| Weekly spontaneous bowel movements (SBM) | Week 5 | The number of spontaneous bowel movements recorded during the first week after the end of intervention, without the use of laxatives. |
| Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) | Baseline, Week 4 | Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
| Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 5 | Baseline, Week 5 | Description: Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
| Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 8 | Baseline, Week 8 | Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
| Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) | Baseline, Week 4 | Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort. |
| Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 5 | Baseline, Week 5 | Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort. |
| Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 8 | Baseline, Week 8 | Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort. |
| Number of participants with acupuncture-related adverse reactions | from baseline to Week 4 | Count of participants who experience acupuncture-related adverse reactions during the study period. |
| Number of participants with TEAS-related skin reactions | from baseline to Week 4 | Count of participants who develop TEAS-related skin reactions during the study period. TEAS = Transcutaneous Electrical Acupoint Stimulation. |
| Number of participants with other adverse events | from baseline to Week 4 | Count of participants experiencing adverse events unrelated to acupuncture or TEAS. |
| Number of participants with serious adverse events | from baseline to Week 4 | Count of participants who experience serious adverse events throughout the study. |
| Acupuncture completion rate | from baseline to Week 4 | Proportion of participants who complete all scheduled acupuncture sessions. |
| TEAS/sham-TEAS completion rate | from baseline to Week 4 | Proportion of participants who complete the scheduled home TEAS or sham TEAS intervention. |
Outcome results
None listed