N/A
Completed N=23
Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C
IBS · chronic constipation
Source: ClinicalTrials.gov NCT04953728 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. — 0.79; 1.32; -4.44; -4.21 mmHg — p=0.77306724
Summary
This study aims to determine the most effective treatment with Transcutaneous Electrical Acustimulation (TEA) for Irritable Bowel Syndrome with Constipation (IBS-C) by comparing efficacy between 5 separate sessions. The rectum pressure as measured by a device called a barostat will be compared between visits. Each session will be testing a different combination of frequency and body position of the electrodes. Electrodes placed at either the wrist or knee will be stimulated at either 25 Hz or 100 Hz.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. |
0.79; 1.32; -4.44; -4.21; 1.84 | 0.77306724 |
| PRIMARY Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. |
-0.53; -1.66; 5.00; -1.05; -1.13; 5.53 | 0.81019363 |
| SECONDARY Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. |
-7.74; -0.94; -4.19; -2.23; -3.74 | 0.00046998 sig |
| SECONDARY Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment. |
-6.80; -3.55; -5.51; -3.99; 3.25; 1.29 | 0.02 sig |
| SECONDARY Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. |
-2.31; 14.08; 11.83; -1.56; 13.48 | 0.87 |
| SECONDARY Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. |
5.79; 0.26; 1.87; 6.05; 2.63 | 0.007 sig |
Eligibility Criteria
Inclusion Criteria
- Willing to comply with all study procedures and be available for the duration of the study
- Diagnosed with IBS-C satisfying Rome IV criteria
- Have symptoms present for at least the last 3 months
- Have abdominal pain that is not adequately relieved at the time of screening and the time of randomization
- Has a Visual Analog Scale (VAS) pain score of >3 (on 0-10 score)
Exclusion Criteria
- Have an unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes, unstable thyroid disease
- Have history of abdominal surgery (other than cholecystectomy or appendectomy)
- Are taking anticoagulants or antispasmodic, antidiarrheal, or opioids or other pain relief medications and cannot stop these medications for three consecutive days before each study visit
- Are pregnant or lactating; women of child bearing potential complete a pregnancy test at each visit
- Have known allergic reactions to components of the ECG electrodes
- Received treatment with an investigational drug or other intervention within 6 months of the date of consent
- Anything that, in the opinion of the investigator, would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study
- Are unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT04953728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.