Irritable Bowel Syndrome With ConstipationNCT06219707
Electro-acupuncture for Irritable Bowel Syndrome With Constipation
A study testing Acupuncture needles in people with Irritable Bowel Syndrome With Constipation, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Sep 2024to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfilment of the Rome IV criteria for IBS-C;
- Age of 21 to 65 years (inclusive);
- Weekly average of worst daily abdominal pain score of ≥3 (0-10 scale) for at least 12 weeks before the first visit and during screening period;
- <3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
- Written informed consent.
Who cannot join
- Pregnancy or breast-feeding;
- Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
- History of gastrointestinal tract segment removal or bariatric surgery for obesity;
- Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
- Unstable medical conditions that could be associated with abdominal pain or discomfort and could potentially influence the assessments in this trial (e.g., chronic kidney disease, endometriosis, lactose intolerance);
- Diagnosed with primary severe mental illness;
Show all 11Show fewer
- Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic;
- Alcoholism or drug abuse in past 1 year;
- Having needle phobia or allergy to acupuncture needle materials;
- Antibiotics and probiotics/prebiotics usage in the previous month;
- Participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Nanyang Technological University, School of Biological Sciences
Singapore, Singapore, 637551
About this study
Official title: Electro-acupuncture for Irritable Bowel Syndrome With Constipation: a Pilot, Randomized, Double-blinded, Sham-controlled Trial
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm. We hypothesize that electro-acupuncture would result in superior symptom improvement compared to sham acupuncture. In addition, biological samples (blood, urine, and stool) will be collected during the trial for future exploratory studies. These samples will be used to investigate changes in gut microbiota composition and related metabolites. These analyses aim to explore potential mechanistic links between electro-acupuncture interventions and clinical outcomes in subsequent research. Apart from the IBS-C participants, 30 healthy volunteers aged 21 to 65 years (inclusive) will be recruited to provide blood, urine, and stool samples. These samples will serve as a reference for comparative analyses with those from IBS-C patients before and after electro-acupuncture treatment. The healthy controls will not receive any interventions.
Read the detailed description
- Study period:
14 weeks, including 2 weeks of run-in (wash-out), 6 weeks of treatment, and 6 weeks of follow-up. 15 visits will be scheduled for each participant, comprising 2 visits during recruitment and the wash-out period, 12 visits during the treatment period, and 1 visit at the end of the follow-up period.
II) Coding of data:
The trial uses patient-blind technique, which means needles for acupuncture and sham acupuncture will be of identical looking and use same package, conduct blinding according to randomization codes. The study will only be unblinded at final statistical analysis and in final report. In case of emergency code breaking, before code breaking, the investigator should well inform the principal investigator of the corresponding participating site. Investigators who break the codes need to explain the reasons and document on patients' notes. The following circumstances can be considered for an emergency breaking, including, but not limited to: (1) When a SAE happens and is considered to be relevant to experimental medication or placebo; (2) When a serious complication happens.
III) AE/SAE reporting:
All AEs that not meeting the criteria for SAEs will be captured on the case report form (CRF). The details include, but not be limited to: (1) date, (2) event description, (3) time of onset, (4) assessment of severity, (5) relationship to study intervention, and (6) time of resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution or stabilization. Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an AE. However, if the study participant's condition deteriorates at any time during the study, it will be recorded as an AE. Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode. Regarding SAEs, the study investigator will immediately report to the principal investigator for any SAE. SAEs will be followed until satisfactory resolution or until the investigator deems the event to be chronic or the participant is stable. Other supporting documentation of the event may be requested by the Research Ethics Committee (REC) and should be provided as soon as possible. All SAE must be evaluated by the principal investigator and investigators. Once it happened, principal investigator must submit a SAE report to REC within 24 hours and follow up within 7 days. All AEs and SAEs will be reported to REC in the annual progress report and in the final study report.
IV) Compliance and dropout:
For maximizing participants' compliances, first, the investigators have a thorough consent process for all participants by explaining the details of the study schedule, potential side effects of treatment, the responsibilities the participants needed to take and together with the support and reassurance during the whole study. Second, the investigators have a careful scrutiny (2-week run-in period) to exclude ineligible and low compliance participants before randomization. Third, a special e-mail account and a direct telephone hotline equipping with this clinical trial are ways for the study team to actively communicate with participants and reply enquiries. Moreover, extra-visits will be arranged for participants to see WM doctor or TCM practitioner if participants develop adverse events before the next scheduled visit. If any patient has thoughts of withdrawing or dropping out, he/she will try to determine the reason. The investigators would try to find solution in order to keep the patient in the study.
- Data collection and management:
Case report forms (CRFs) will be filled in by investigators. Collectable information includes patient identification and demographic data, clinical history, dietary history, personal history, family history, substance use, IBS medical history and clinical examination. Data processing will be conducted in accordance with the following protocol:
- Verification of CRFs: Investigators need to verify CRFs before inputting.
- Data verification needs to be conducted successively in the following two steps:
- Verify the consistency and logicality of data: Review contents of data range and logicality will be determined by the range of each index and the interrelation. Corresponding software formula will also be applied to assist the data input.
- Compare database and CRFs by manual testing. Selectively counter check 10% CRFs with participants' medical notes to check the quality of input and analyze.
- Data inspection and closure of database: After verifying the validity of established database and statistical protocol, principal investigators will lock the data. The locked data are not allowed to change. Confirmed problems found after locking will be handled in the process of statistical analysis. All mistakes and modification should be recorded and kept properly.
Investigators should keep all trial materials, including acknowledgement of all participants, original informed consent forms with participant's signature, all CRFs and detailed record of medications distribution, which should be provided to ethics committee and drug supervision and administration department for reviewing. All files will be maintained in storage for a period of 7 years after the completion of the clinical trial. Data access during study will be restricted except investigators, ethics committee, and government authority. After the study, all the data will be deidentified and available for sharing upon reasonable request.
VI) Sample size calculation:
The study is the first sham-controlled acupuncture trial that uses the Food and Drug Administration (FDA) recommended end point for IBS-C. The sample size was determined based on the study's purpose, statistical precision, feasibility, and reported improvements in clinical symptoms (abdominal pain, bloating, feeling of incomplete defecation, stool frequency, stool shape) from previous acupuncture studies on IBS-C patients. With an alpha of 0.05, a power of 0.8, a 20% dropout rate, and the potential for missing data, a total sample size of 60 patients (30 in experimental arm and 30 in control arm) is required.
VII) Statistical analysis:
All efficacy and safety analyses will be conducted based on intention-to-treat (ITT) principle. Missing values will be imputed by the last-observation-carried-forward method. The statistical analysis will be performed using the Stata software. The statistical significance will be defined as two-sided P-value of <0.05. Baseline characteristics will be reported as mean (SD). Baseline differences between the groups will be evaluated with the application of Student's t-test for normally distributed continuous variables and non-parametric Mann-Whitney U test for non-normally distributed variables. For categorical variables, chi-squared test or Fisher's exact test will be applied. Comparisons between groups will be conducted by using unpaired t-test for normally distributed data and Mann-Whitney test for non-normally distributed data. Within group differences will be evaluated with paired t-test for normally distributed data and Wilcoxon signed-rank test for non-normally distributed data.
- Being tested
- Acupuncture needles
- Keywords
- Acupuncture, Irritable Bowel Syndrome with Constipation, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
| Study group | Role | What they receive |
|---|---|---|
| Electro-Acupuncture group | Experimental | Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. The alternating stimulation is believed to produce maximal biochemical responses in the brain. Receives: Device: Acupuncture needles |
| Sham-Acupuncture group | Sham comparator | Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted (actual penetration of the skin) at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli. The sham points aren't acupuncture points nor located on meridians. Both the electroacupuncture and sham acupuncture groups follow the same procedures, including connection to the stimulator device for the same duration. In the sham group, although no electrical current is delivered, the power switch is turned on and the knobs are manipulated to produce audible clicking sounds, mimicking auditory cues of active treatment. Receives: Device: Acupuncture needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM
Proportion of patients with a decrease in the weekly average of worst abdominal pain scores of ≥30% and a weekly increase of ≥1 CSBM as compared with the baseline.
Measured: Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)
Secondary outcomes (26)
Proportion of patients with an improvement of ≥30% in abdominal pain scores
Proportion of patients with an improvement of ≥30% in abdominal pain scores from baseline.
Measured: Baseline, week 8, week 14
Proportion of patients with an average increase of 1 or more spontaneous, complete bowel movements per week
Proportion of patients with an average increase of 1 or more spontaneous, complete bowel movements per week as compared with the baseline.
Measured: Baseline, week 8, week 14
Average number of spontaneous bowel movements, complete spontaneous bowel movements per week
Average number of spontaneous bowel movements, complete spontaneous bowel movements per week as compared with the baseline.
Measured: Baseline, week 8, week 14
Percentage of bowel movements with normal consistency
Percentage of bowel movements with normal consistency as compared with the baseline.
Measured: Baseline, week 8, week 14
Percentage of bowel movements with severe or very severe straining during defecation
Percentage of bowel movements with severe or very severe straining during defecation as compared with the baseline.
Measured: Baseline, week 8, week 14
Median time to the first spontaneous bowel movements, complete spontaneous bowel movements after electro-acupuncture
Median time to the first spontaneous bowel movements, complete spontaneous bowel movements after intake of the first session of electro-acupuncture.
Measured: From first session of electro-acupuncture up to the end of follow-up, approximately 12 weeks
Average number of bisacodyl tablets or enemas used per week
Average number of bisacodyl tablets or enemas used per week as compared with the baseline number.
Measured: Baseline, week 8, week 14
Global assessment of efficacy of treatment with Likert scale
Global assessment of efficacy of treatment with Likert scale (range: 1-5) at weeks 5, 8, and 14.
Measured: Week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using IBS Symptom Severity Scale (IBS-SSS)
IBS-SSS (range: 0-500) is a questionnaire used to assess the severity of symptoms in individuals with Irritable Bowel Syndrome (IBS). It typically includes questions related to abdominal pain, bloating, stool consistency, and the impact of IBS symptoms on daily life. Higher scores on this scale indicate more severe symptoms.
Measured: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using IBS Quality of Life (IBS-QOL)
IBS-QOL (range: 0-100) is a measure designed to assess the impact of IBS on a person's quality of life. It includes questions related to how IBS symptoms affect various aspects of daily functioning, such as physical health, emotional well-being, and social activities. Lower scores on this scale indicate a lower quality of life due to IBS.
Measured: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Patient Assessment of Constipation Symptoms (PAC-SYM)
PAC-SYM (range for each item: 0-4) is a questionnaire used to evaluate the severity and frequency of constipation-related symptoms in patients. It typically covers symptoms like abdominal discomfort, straining during bowel movements, and incomplete evacuation. Higher scores suggest more severe constipation symptoms.
Measured: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Constipation Quality of Life (PAC-QOL)
PAC-QOL (range for each item: 0-4) is a measure that assesses the impact of constipation on a person's quality of life. It includes questions about how constipation symptoms affect daily activities, emotional well-being, and overall satisfaction with life. Lower scores indicate a poorer quality of life related to constipation.
Measured: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Patient Health Questionnaire-15 (PHQ-15)
PHQ-15 (range: 0-30) is a self-report questionnaire that assesses somatic symptom severity in individuals. It includes questions related to various physical symptoms, such as headaches, back pain, and stomach discomfort. It is often used as a screening tool to assess somatic symptom burden, and higher scores indicate a greater presence of somatic symptoms.
Measured: Baseline, week 5, week 8, week 14
Change from baseline in the psychological conditions using Hamilton Depression Scale (HAMD)
HAMD (range: 0-52 for HAMD-17) is a clinician-administered questionnaire used to assess the severity of depressive symptoms in individuals with depression. It includes items related to mood, feelings of guilt, sleep disturbances, and physical symptoms. Higher scores indicate more severe depression.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Self-rating Depression Scale (SDS)
SDS (range: 20-80) is a self-report questionnaire designed to assess the presence and severity of depressive symptoms from the perspective of the individual. It includes questions about mood, feelings of sadness, and physical symptoms associated with depression. Higher scores suggest greater self-reported depression.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Patient Health Questionnaire (PHQ-9)
PHQ-9 (range: 0-27) is a widely used self-report tool for assessing depression. It consists of nine questions that correspond to the criteria for major depressive disorder. Individuals rate the frequency of their symptoms over the past two weeks. Higher scores indicate more severe depression.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using General Anxiety Disorder (GAD-7)
GAD-7 (range: 0-21) is a self-report questionnaire used to assess the presence and severity of generalized anxiety disorder symptoms. It includes questions related to excessive worry, restlessness, and physical symptoms associated with anxiety. Higher scores indicate greater anxiety.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Hospital Anxiety and Depression Scale (HADS)
HADS (range for each subscale: 0-21) is a self-report questionnaire that assesses both anxiety and depression symptoms in individuals, often used in healthcare settings. It includes items related to mood, anxiety, and physical symptoms. It provides separate scores for anxiety and depression.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Visceral Sensitivity Index (VSI)
VSI (range: 0-75) is a self-report questionnaire used to assess the degree of visceral hypersensitivity in individuals with conditions like irritable bowel syndrome. It includes questions about gastrointestinal symptoms and discomfort, helping to measure sensitivity to visceral sensations.
Measured: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Perceived Stress Scale (PSS)
PSS (range: 0-40) is a self-report questionnaire that measures an individual's perception of stress in their life. It includes questions about how often one perceives situations as stressful and their ability to cope with stress. Higher scores indicate greater perceived stress.
Measured: Baseline, week 8, week 14
Patient expectancy and trust in treatment with Likert scale
Assessment of patient expectancy and trust in treatment with Likert scale (range: 1-5) at weeks 2, 8, and 14. Higher scores suggest greater confidence, satisfaction, trust, and positive perception of the treatment.
Measured: Week 2, week8, week 14
Recruitment rate
Number of eligible participants who consent and are enrolled in the study divided by the total number of participants screened for eligibility, reported as a percentage.
Measured: Baseline
Retention rate
Number of enrolled participants who complete the final study visit divided by the total number of enrolled participants, reported as a percentage.
Measured: Baseline to week 14
Adherence to treatment protocols
Proportion of prescribed treatments completed per participant, calculated as the number of treatment sessions received divided by the number of sessions planned, reported as a percentage.
Measured: Baseline to week 14
Completeness and quality of symptom diaries and questionnaire responses
Percentage of symptom diaries and questionnaires that are fully completed with no missing or invalid entries, calculated as the number of complete and valid responses divided by the total number of expected responses.
Measured: Baseline, week 5, week 8, week 14
Number and type of adverse events documented
Total number and types of adverse events recorded throughout the study, categorized by severity and relatedness to the intervention.
Measured: Baseline to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start12 Sep 2024
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be scheduled for a total of 12 treatment sessions, 30 minutes for each session, 2 times a week over 6-week period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Linda Zhong, Nanyang Technological University
- Investigators
- Linda LD Zhong, PhD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219707
- Sponsor's protocol ID
- IRB-2023-451
- Status last verified
- May 2026
- First submitted
- 12 Jan 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing will be available upon request.
Publications
Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.
PubMed 12495858Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
PubMed 27618593Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.
PubMed 18509121Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.
PubMed 28274109Lam WC, Chen H, Siah KTH, Thakur ER, Zhong LLD. Electro-acupuncture for irritable bowel syndrome with constipation: study protocol of a pilot, randomized, double-blinded, sham-controlled trial. Front Neurol. 2025 Sep 12;16:1632822. doi: 10.3389/fneur.2025.1632822. eCollection 2025.
PubMed 41018183
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture for Irritable Bowel Syndrome With Constipation: a Pilot, Randomized, Double-blinded, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT06219707
- Acronym / sponsor ID
- IRB-2023-451
- Keywords
- Acupuncture, Irritable Bowel Syndrome with Constipation, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm. We hypothesize that electro-acupuncture would result in superior symptom improvement compared to sham acupuncture. In addition, biological samples (blood, urine, and stool) will be collected during the trial for future exploratory studies. These samples will be used to investigate changes in gut microbiota composition and related metabolites. These analyses aim to explore potential mechanistic links between electro-acupuncture interventions and clinical outcomes in subsequent research. Apart from the IBS-C participants, 30 healthy volunteers aged 21 to 65 years (inclusive) will be recruited to provide blood, urine, and stool samples. These samples will serve as a reference for comparative analyses with those from IBS-C patients before and after electro-acupuncture treatment. The healthy controls will not receive any interventions.
Detailed description
- Study period:
14 weeks, including 2 weeks of run-in (wash-out), 6 weeks of treatment, and 6 weeks of follow-up. 15 visits will be scheduled for each participant, comprising 2 visits during recruitment and the wash-out period, 12 visits during the treatment period, and 1 visit at the end of the follow-up period.
II) Coding of data:
The trial uses patient-blind technique, which means needles for acupuncture and sham acupuncture will be of identical looking and use same package, conduct blinding according to randomization codes. The study will only be unblinded at final statistical analysis and in final report. In case of emergency code breaking, before code breaking, the investigator should well inform the principal investigator of the corresponding participating site. Investigators who break the codes need to explain the reasons and document on patients' notes. The following circumstances can be considered for an emergency breaking, including, but not limited to: (1) When a SAE happens and is considered to be relevant to experimental medication or placebo; (2) When a serious complication happens.
III) AE/SAE reporting:
All AEs that not meeting the criteria for SAEs will be captured on the case report form (CRF). The details include, but not be limited to: (1) date, (2) event description, (3) time of onset, (4) assessment of severity, (5) relationship to study intervention, and (6) time of resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution or stabilization. Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an AE. However, if the study participant's condition deteriorates at any time during the study, it will be recorded as an AE. Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode. Regarding SAEs, the study investigator will immediately report to the principal investigator for any SAE. SAEs will be followed until satisfactory resolution or until the investigator deems the event to be chronic or the participant is stable. Other supporting documentation of the event may be requested by the Research Ethics Committee (REC) and should be provided as soon as possible. All SAE must be evaluated by the principal investigator and investigators. Once it happened, principal investigator must submit a SAE report to REC within 24 hours and follow up within 7 days. All AEs and SAEs will be reported to REC in the annual progress report and in the final study report.
IV) Compliance and dropout:
For maximizing participants' compliances, first, the investigators have a thorough consent process for all participants by explaining the details of the study schedule, potential side effects of treatment, the responsibilities the participants needed to take and together with the support and reassurance during the whole study. Second, the investigators have a careful scrutiny (2-week run-in period) to exclude ineligible and low compliance participants before randomization. Third, a special e-mail account and a direct telephone hotline equipping with this clinical trial are ways for the study team to actively communicate with participants and reply enquiries. Moreover, extra-visits will be arranged for participants to see WM doctor or TCM practitioner if participants develop adverse events before the next scheduled visit. If any patient has thoughts of withdrawing or dropping out, he/she will try to determine the reason. The investigators would try to find solution in order to keep the patient in the study.
- Data collection and management:
Case report forms (CRFs) will be filled in by investigators. Collectable information includes patient identification and demographic data, clinical history, dietary history, personal history, family history, substance use, IBS medical history and clinical examination. Data processing will be conducted in accordance with the following protocol:
- Verification of CRFs: Investigators need to verify CRFs before inputting.
- Data verification needs to be conducted successively in the following two steps:
- Verify the consistency and logicality of data: Review contents of data range and logicality will be determined by the range of each index and the interrelation. Corresponding software formula will also be applied to assist the data input.
- Compare database and CRFs by manual testing. Selectively counter check 10% CRFs with participants' medical notes to check the quality of input and analyze.
- Data inspection and closure of database: After verifying the validity of established database and statistical protocol, principal investigators will lock the data. The locked data are not allowed to change. Confirmed problems found after locking will be handled in the process of statistical analysis. All mistakes and modification should be recorded and kept properly.
Investigators should keep all trial materials, including acknowledgement of all participants, original informed consent forms with participant's signature, all CRFs and detailed record of medications distribution, which should be provided to ethics committee and drug supervision and administration department for reviewing. All files will be maintained in storage for a period of 7 years after the completion of the clinical trial. Data access during study will be restricted except investigators, ethics committee, and government authority. After the study, all the data will be deidentified and available for sharing upon reasonable request.
VI) Sample size calculation:
The study is the first sham-controlled acupuncture trial that uses the Food and Drug Administration (FDA) recommended end point for IBS-C. The sample size was determined based on the study's purpose, statistical precision, feasibility, and reported improvements in clinical symptoms (abdominal pain, bloating, feeling of incomplete defecation, stool frequency, stool shape) from previous acupuncture studies on IBS-C patients. With an alpha of 0.05, a power of 0.8, a 20% dropout rate, and the potential for missing data, a total sample size of 60 patients (30 in experimental arm and 30 in control arm) is required.
VII) Statistical analysis:
All efficacy and safety analyses will be conducted based on intention-to-treat (ITT) principle. Missing values will be imputed by the last-observation-carried-forward method. The statistical analysis will be performed using the Stata software. The statistical significance will be defined as two-sided P-value of <0.05. Baseline characteristics will be reported as mean (SD). Baseline differences between the groups will be evaluated with the application of Student's t-test for normally distributed continuous variables and non-parametric Mann-Whitney U test for non-normally distributed variables. For categorical variables, chi-squared test or Fisher's exact test will be applied. Comparisons between groups will be conducted by using unpaired t-test for normally distributed data and Mann-Whitney test for non-normally distributed data. Within group differences will be evaluated with paired t-test for normally distributed data and Wilcoxon signed-rank test for non-normally distributed data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will be scheduled for a total of 12 treatment sessions, 30 minutes for each session, 2 times a week over 6-week period.
| Arm | Type | Receives |
|---|---|---|
| Electro-Acupuncture group | Experimental | Device: Acupuncture needlesDisposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. The alternating stimulation is believed to produce maximal biochemical responses in the brain. |
| Sham-Acupuncture group | Sham comparator | Device: Acupuncture needlesDisposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted (actual penetration of the skin) at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli. The sham points aren't acupuncture points nor located on meridians. Both the electroacupuncture and sham acupuncture groups follow the same procedures, including connection to the stimulator device for the same duration. In the sham group, although no electrical current is delivered, the power switch is turned on and the knobs are manipulated to produce audible clicking sounds, mimicking auditory cues of active treatment. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfilment of the Rome IV criteria for IBS-C;
- Age of 21 to 65 years (inclusive);
- Weekly average of worst daily abdominal pain score of ≥3 (0-10 scale) for at least 12 weeks before the first visit and during screening period;
- <3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
- Written informed consent.
Key exclusion criteria (11 listed)
- Pregnancy or breast-feeding;
- Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
- History of gastrointestinal tract segment removal or bariatric surgery for obesity;
- Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
- Unstable medical conditions that could be associated with abdominal pain or discomfort and could potentially influence the assessments in this trial (e.g., chronic kidney disease, endometriosis, lactose intolerance);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture needlesThe acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore. | Device | Electro-Acupuncture group, Sham-Acupuncture group |
Primary outcome
Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM
Time frame: Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)
Proportion of patients with a decrease in the weekly average of worst abdominal pain scores of ≥30% and a weekly increase of ≥1 CSBM as compared with the baseline.
26 secondary outcomes
Proportion of patients with an improvement of ≥30% in abdominal pain scores
Time frame: Baseline, week 8, week 14
Proportion of patients with an average increase of 1 or more spontaneous, complete bowel movements per week
Time frame: Baseline, week 8, week 14
Average number of spontaneous bowel movements, complete spontaneous bowel movements per week
Time frame: Baseline, week 8, week 14
Percentage of bowel movements with normal consistency
Time frame: Baseline, week 8, week 14
Percentage of bowel movements with severe or very severe straining during defecation
Time frame: Baseline, week 8, week 14
Median time to the first spontaneous bowel movements, complete spontaneous bowel movements after electro-acupuncture
Time frame: From first session of electro-acupuncture up to the end of follow-up, approximately 12 weeks
Average number of bisacodyl tablets or enemas used per week
Time frame: Baseline, week 8, week 14
Global assessment of efficacy of treatment with Likert scale
Time frame: Week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using IBS Symptom Severity Scale (IBS-SSS)
Time frame: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using IBS Quality of Life (IBS-QOL)
Time frame: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Constipation Quality of Life (PAC-QOL)
Time frame: Baseline, week 5, week 8, week 14
Change from baseline in the IBS-C symtoms using Patient Health Questionnaire-15 (PHQ-15)
Time frame: Baseline, week 5, week 8, week 14
Change from baseline in the psychological conditions using Hamilton Depression Scale (HAMD)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Self-rating Depression Scale (SDS)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using General Anxiety Disorder (GAD-7)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Visceral Sensitivity Index (VSI)
Time frame: Baseline, week 8, week 14
Change from baseline in the psychological conditions using Perceived Stress Scale (PSS)
Time frame: Baseline, week 8, week 14
Patient expectancy and trust in treatment with Likert scale
Time frame: Week 2, week8, week 14
Recruitment rate
Time frame: Baseline
Retention rate
Time frame: Baseline to week 14
Adherence to treatment protocols
Time frame: Baseline to week 14
Completeness and quality of symptom diaries and questionnaire responses
Time frame: Baseline, week 5, week 8, week 14
Number and type of adverse events documented
Time frame: Baseline to week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 12495858Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.
- Background: PubMed 27618593Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
- Background: PubMed 18509121Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.
- Background: PubMed 28274109Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.
- Derived from this study: PubMed 41018183Lam WC, Chen H, Siah KTH, Thakur ER, Zhong LLD. Electro-acupuncture for irritable bowel syndrome with constipation: study protocol of a pilot, randomized, double-blinded, sham-controlled trial. Front Neurol. 2025 Sep 12;16:1632822. doi: 10.3389/fneur.2025.1632822. eCollection 2025.
- Individual participant dataSharing planned: Yes. IPD sharing will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda LD Zhong, PhD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Irritable Bowel Syndrome With Constipation, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM (time frame: Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219707, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.