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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS115108-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Transtimulation Research, Inc | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
This study aims to discern whether acute, single-session Transcutaneous Electrical Acustimulation (TEA) at acupuncture points ST36 or PC6 will relieve abdominal pain induced by rectal distension in patients with IBS-C. Each study participant will have 5 research visits at the Michigan Medicine GI physiology lab. During these visits, participants will undergo a procedure similar to Anal Rectal Manometry (ARM) performed by the GI physiology lab staff. TEA is similar to this procedure as it uses the barostat device and is performed by the GI physiology lab staff. This device has a rubber catheter that will be inserted 5-15 cm into the rectum of the study participant. Then the GI physiology staff will inflate the catheter. Study participants will then be asked when they can sense the catheter. Then the GI physiology staff will continue to inflate the catheter and the study participants feel discomfort (described as the 'urge to defecate'). Then the study participant will be asked to pass the balloon (like they would pass a bowel movement).
The difference between ARM procedure and the study procedure is that there will be stimulation of acupuncture point ST36 which is below the knee cap or stimulation of acupuncture point PC6 which is just above the wrist. For this study, this mild electrical stimulation will occur simultaneously with the barostat procedure.
At each visit there will be stimulation of only one of the points at either 100Hz or 25Hz. These are the potential combinations: ST36 100Hz, ST36-25Hz, PC6-100Hz, PC6-25Hz, Sham-TEA.
The frequency and position combination (or sham visit) is randomly assigned. The randomization determines the order in which the study participant moves through the study. Every study participant will, in the end, complete one visit at each frequency and a sham visit. The study participant will also complete surveys at the appointment.
The TEA device is classified by the FDA as a non-significant risk device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with IBS-C | Experimental | All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Device | Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's tolerance with stimulation and that participant's baseline for that day. | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
| Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention was compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham for that person. Higher numbers represent a higher degree of tolerance. Scores were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average maximums under 1 treatment or another for the group as a whole. | After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score was 0 and the maximum possible score was 80, if a participant experienced 10/10 pain. These scores were collected at 15 through 50 mmHg of distension at 5-mmHg intervals during baseline and compared to the scores collected at the same intervals during treatment on the same day. Data below show values post stimulation minus pre stimulation. Each participant came in for 1 treatment in 1 session on each of 5 separate days. Sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pain compared only to their own pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiande Chen, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25989154 | Background | Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738. | |
| 24657460 | Background | Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20. |
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De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
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Recruitment was opened in May 2021, and the first participant was consented July 1, 2021. Recruitment closed in September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With IBS-C | All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With IBS-C | All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 to 3 weeks apart. Transcutaneous Electrical Acustimulation (TEA): Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's tolerance with stimulation and that participant's baseline for that day. | Data was analyzed only for participants who received all 5 treatments to avoid the compounding impact of day-to-day variations. In the case of PC6 100 HZ, post-treatment value is missing for 1 participant. | Posted | Mean | Standard Error | mmHg | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
Adverse events were recorded from first visit of the study to one month after the last visit of the study, a maximum of 16 weeks.
Data in this module is presented under each treatment. The treatments do not represent separate arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ST36 100 HZ | Administration of 100 HZ to acupressure point ST36 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment | Noticed 7 days after the previous study visit where sham stimulation was administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiande Chen | University of Michigan | 734-764-3880 | cjiande@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2022 | Dec 4, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2022 | Jan 22, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All participants will receive all treatments including sham comparator in a randomized order. Participants will not be informed of which treatment they will be receiving or the treatment order to which they are assigned.
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| Up to 8 mins between 15 and 50 mmHg during baseline. After deflating balloon, 15 mins of treatment and resumption of distention (up to 30 mins later), more surveys were taken during treatment increasing distensions up to 8 mins between 15 and 50 mmHg. |
| 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. | VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score is 0 and the maximum possible score is 80, if a participant experienced 10/10 pain. These scores, collected at maximum distension during treatment, were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham for each individual. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average pain scores under 1 treatment or another for the group as a whole. | Surveys taking less than 1 minute were taken at maximum-tolerated distension during treatment. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 survey and another was 12 weeks. |
| Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device will measure the volume changes in the rectum during controlled distension, as measured in milliliters. The study participant's maximum volume will be compared to tolerance pre and post TEA. A higher number corresponds to a higher maximum volume. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' maximum volume may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's maximum volume with stimulation and that participant's baseline for that day. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's maximum volume compared only to their own maximum volume. | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
| Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. Values below show the pressure at which each participant experienced first sensation of the rectum during stimulation minus the pressure at which each participant experienced first sensation at baseline. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pressure may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pressure compared only to their own pressure. | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
| 28915981 | Background | Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30. |
| 31347247 | Background | Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26. |
| 29925916 | Background | Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pressure of Maximum Tolerance | Pressure of Maximum Tolerance of the Rectum as Measured by a Barostat Device Pre TEA Administration | Only data from participants who were administered all treatments (19 participants) was analyzed to ensure pre- and post-comparisons by individual. Where data is presented for only 18 participants, 1 participant at baseline did not reach a maximum tolerance even at the maximum-offered pressure. | Mean | Standard Deviation | mmHg |
|
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|
|
| Primary | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention was compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham for that person. Higher numbers represent a higher degree of tolerance. Scores were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average maximums under 1 treatment or another for the group as a whole. | For each of the rows of data below, data from 19 participants at one treatment are compared with data from either 19 or 18 participants in the other treatment. | Posted | Mean | Standard Error | mmHg | After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks. |
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|
|
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| Secondary | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score was 0 and the maximum possible score was 80, if a participant experienced 10/10 pain. These scores were collected at 15 through 50 mmHg of distension at 5-mmHg intervals during baseline and compared to the scores collected at the same intervals during treatment on the same day. Data below show values post stimulation minus pre stimulation. Each participant came in for 1 treatment in 1 session on each of 5 separate days. Sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pain compared only to their own pain. | Posted | Mean | Standard Error | score on a scale | Up to 8 mins between 15 and 50 mmHg during baseline. After deflating balloon, 15 mins of treatment and resumption of distention (up to 30 mins later), more surveys were taken during treatment increasing distensions up to 8 mins between 15 and 50 mmHg. |
|
|
|
|
| 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. | VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score is 0 and the maximum possible score is 80, if a participant experienced 10/10 pain. These scores, collected at maximum distension during treatment, were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham for each individual. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average pain scores under 1 treatment or another for the group as a whole. | For each of the rows of data below, data from 19 participants at one treatment are compared with data from either 19 or 18 participants in the other treatment. | Posted | Mean | Standard Error | score on a scale | Surveys taking less than 1 minute were taken at maximum-tolerated distension during treatment. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 survey and another was 12 weeks. |
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| Secondary | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device will measure the volume changes in the rectum during controlled distension, as measured in milliliters. The study participant's maximum volume will be compared to tolerance pre and post TEA. A higher number corresponds to a higher maximum volume. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' maximum volume may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's maximum volume with stimulation and that participant's baseline for that day. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's maximum volume compared only to their own maximum volume. | Data from participants who did not reach a maximum tolerance at a preset maximum distension pressure of 60 mmHg were not analyzed. For some participants, the barostat was unable to provide complete data to allow analysis. | Posted | Mean | Standard Error | mL | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
|
|
|
|
| Secondary | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. Values below show the pressure at which each participant experienced first sensation of the rectum during stimulation minus the pressure at which each participant experienced first sensation at baseline. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pressure may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pressure compared only to their own pressure. | In the case of PC6 100 HZ, post-treatment value is missing for 1 participant. | Posted | Mean | Standard Error | mmHg | Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off. |
|
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | ST36 25 HZ | Administration of 25 HZ to acupressure point ST36 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | PC6 100 HZ | Administration of 100 HZ to acupressure point PC6 | 0 | 20 | 0 | 20 | 1 | 20 |
| EG003 | PC6 25 HZ | Administration of 25 HZ to acupressure point PC6 | 0 | 19 | 0 | 19 | 0 | 19 |
| EG004 | Sham 25 HZ | Administration of 25 HZ to sham acupressure point | 0 | 22 | 0 | 22 | 2 | 22 |
|
| Belching | Gastrointestinal disorders | Systematic Assessment | belching occurred after completion of the first distension and prior to sham stimulation |
|
| Hematochezia | Gastrointestinal disorders | Systematic Assessment | Noticed upon removal of balloon after PC6-100Hz stimulation. |
|
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| Change in avg max tolerance per person: value at ST36 100Hz minus value at sham |
|
| Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 100Hz |
|
| Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 25Hz |
|
| Change in avg max tolerance per person: value at ST36 25Hz minus value at sham |
|
| Change in avg max tolerance per person: value at PC6 100Hz minus value at PC6 25Hz |
|
| Change in avg max tolerance per person: value at PC6 100Hz minus value at sham |
|
| Change in avg max tolerance per person: value at PC6 25Hz minus value at sham |
|
| 0.18 |
| Superiority |
| Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz | t-test, 2 sided | 0.21 | Superiority |
| Change in average maximum tolerance of ST36 100Hz when compared to Sham | t-test, 2 sided | 0.58 | Superiority |
| Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz | t-test, 2 sided | 0.18 | Superiority |
| Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz | t-test, 2 sided | 0.18 | Superiority |
| Change in average maximum tolerance of ST36 25Hz when compared to sham | t-test, 2 sided | 0.78 | Superiority |
| Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz | t-test, 2 sided | 0.89 | Superiority |
| Change in average maximum tolerance of PC6 100Hz when compared to sham | t-test, 2 sided | 0.05 | Superiority |
| Change in average maximum tolerance of PC6 25Hz when compared to sham | t-test, 2 sided | 0.07 | Superiority |
| Title | Measurements |
|---|---|
|
| PC6 25Hz |
|
| Sham |
|
| 0.74369428 |
| Superiority |
| PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation | t-test, 2 sided | 0.09854383 | Superiority |
| PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation | t-test, 2 sided | 0.24872746 | Superiority |
| Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation | t-test, 2 sided | 0.04828889 | Superiority |
|
| Change in VAS per person: value at ST36 100Hz minus value at Sham |
|
| Change in VAS per person: value at ST36 25Hz minus value at PC6 100Hz |
|
| Change in VAS per person: value at ST36 25Hz minus value at PC6 25Hz |
|
| Change in VAS per person: value at ST36 25Hz minus value at Sham |
|
| Change in VAS per person: value at PC6 100Hz minus value at PC6 25Hz |
|
| Change in VAS per person: value at PC6 100Hz minus value at Sham |
|
| Change in VAS per person: value at PC6 25Hz minus value at Sham |
|
| 0.11 |
| Superiority |
| ST36 100Hz compared to PC6 25Hz | t-test, 1 sided | 0.01 | Superiority |
| ST36 100Hz compared to Sham | t-test, 1 sided | 0.04 | Superiority |
| ST36 25Hz compared to PC6 100Hz | t-test, 1 sided | 0.11 | Superiority |
| ST36 25Hz compared to PC6 25Hz | t-test, 1 sided | 0.23 | Superiority |
| ST36 25Hz compared to Sham | t-test, 1 sided | 0.17 | Superiority |
| PC6 100Hz compared to PC6 25Hz | t-test, 1 sided | 0.15 | Superiority |
| PC6 100Hz compared to Sham | t-test, 1 sided | 0.43 | Superiority |
| PC6 25Hz compared to Sham | t-test, 1 sided | 0.19 | Superiority |
|
| Change in max vol per participant in mL of the rectum during PC6 100Hz minus max vol at baseline |
|
|
| Change in max vol per participant in mL of the rectum during PC6 25Hz minus max vol at baseline |
|
|
| Change in max vol per participant in mL of the rectum during sham minus max vol at baseline |
|
|
| 0.13 |
| Superiority |
| Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline | t-test, 2 sided | 0.17 | Superiority |
| Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline | t-test, 2 sided | 0.88 | Superiority |
| Change in maximum volume in mL of the rectum during sham when compared to baseline | t-test, 2 sided | 0.14 | Superiority |
|
| PC6 100Hz |
|
|
| PC6 25Hz |
|
|
| Sham |
|
|
| 0.83 |
| Superiority |
| Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline | t-test, 2 sided | 0.87 | Superiority |
| Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline | t-test, 2 sided | 0.004 | Superiority |
| Change in first sensation in mmHg of the rectum during sham when compared to baseline | t-test, 2 sided | 0.056 | Superiority |