IBS, Constipation
Conditions
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
National Institutes of Health (NIH)
Transtimulation Research, Inc
National Institute of Neurological Disorders and Stroke (NINDS)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | 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. | 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. |
| Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | 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. | 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. |
| 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. | 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. | 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. |
| Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | 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. | 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. |
| Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was opened in May 2021, and the first participant was consented July 1, 2021. Recruitment closed in September 2022.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Subjects With IBS-C |
|---|---|
| Age, Continuous | 36.26 years STANDARD_DEVIATION 8.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre PC6 100Hz | 47.22 mmHg STANDARD_DEVIATION 9.27 |
| Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre PC6 25Hz | 49.17 mmHg STANDARD_DEVIATION 10.18 |
| Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre sham | 46.39 mmHg STANDARD_DEVIATION 10.26 |
| Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre ST36 100Hz | 47.22 mmHg STANDARD_DEVIATION 9.74 |
| Pressure of Maximum Tolerance Average baseline maximum tolerance of subjects pre ST36 25Hz | 45.53 mmHg STANDARD_DEVIATION 10.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 1 / 20 | 0 / 19 | 2 / 22 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 19 | 0 / 22 |
Outcome results
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 100Hz minus value at ST36 25Hz | -0.53 mmHg | Standard Error 2.03 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 100Hz | -1.66 mmHg | Standard Error 1.04 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 25Hz | 5.00 mmHg | Standard Error 2.6 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 100Hz minus value at sham | -1.05 mmHg | Standard Error 1.42 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 100Hz | -1.13 mmHg | Standard Error 1.26 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 25Hz | 5.53 mmHg | Standard Error 2.83 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at ST36 25Hz minus value at sham | -0.53 mmHg | Standard Error 1.64 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at PC6 100Hz minus value at PC6 25Hz | 6.66 mmHg | Standard Error 1.84 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at PC6 100Hz minus value at sham | 0.61 mmHg | Standard Error 0.65 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities. | Change in avg max tolerance per person: value at PC6 25Hz minus value at sham | -6.05 mmHg | Standard Error 2.22 |
Comparison: Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hzp-value: 0.81019363t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hzp-value: 0.18t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hzp-value: 0.21t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 100Hz when compared to Shamp-value: 0.58t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hzp-value: 0.18t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hzp-value: 0.18t-test, 2 sided
Comparison: Change in average maximum tolerance of ST36 25Hz when compared to shamp-value: 0.78t-test, 2 sided
Comparison: Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hzp-value: 0.89t-test, 2 sided
Comparison: Change in average maximum tolerance of PC6 100Hz when compared to shamp-value: 0.05t-test, 2 sided
Comparison: Change in average maximum tolerance of PC6 25Hz when compared to shamp-value: 0.07t-test, 2 sided
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in avg max tolerance per person: value at ST36 100Hz minus value at that day's baseline | 0.79 mmHg | Standard Error 1.8 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in avg max tolerance per person: value at ST36 25Hz minus value at that day's baseline | 1.32 mmHg | Standard Error 2.26 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in avg max tolerance per person: value at PC6 100Hz minus value at that day's baseline | -4.44 mmHg | Standard Error 2.45 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in avg max tolerance per person: value at PC6 25Hz minus value at that day's baseline | -4.21 mmHg | Standard Error 3.4 |
| Subjects With IBS-C | Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in avg max tolerance per person: value at sham minus value at that day's baseline | 1.84 mmHg | Standard Error 1.03 |
Comparison: Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baselinep-value: 0.77306724t-test, 2 sided
Comparison: Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baselinep-value: 0.24t-test, 2 sided
Comparison: Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baselinep-value: 0.45t-test, 2 sided
Comparison: Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baselinep-value: 0.13t-test, 2 sided
Comparison: Change in maximum tolerance in mmHg of the rectum during Sham when compared to baselinep-value: 0.14t-test, 2 sided
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 25Hz minus value at PC6 100Hz | 3.25 score on a scale | Standard Error 2.62 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 100Hz minus value at PC6 100Hz | -3.55 score on a scale | Standard Error 2.11 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 100Hz minus value at PC6 25Hz | -5.51 score on a scale | Standard Error 1.84 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 100Hz minus value at Sham | -3.99 score on a scale | Standard Error 1.79 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 25Hz minus value at PC6 25Hz | 1.29 score on a scale | Standard Error 2.35 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 25Hz minus value at Sham | 2.80 score on a scale | Standard Error 2.3 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at PC6 100Hz minus value at PC6 25Hz | -1.96 score on a scale | Standard Error 2.14 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at PC6 100Hz minus value at Sham | -0.45 score on a scale | Standard Error 2.09 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at PC6 25Hz minus value at Sham | 1.52 score on a scale | Standard Error 1.82 |
| Subjects With IBS-C | 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. | Change in VAS per person: value at ST36 100Hz minus value at ST36 25Hz | -6.80 score on a scale | Standard Error 2.33 |
Comparison: ST36 100Hz compared to ST36 25Hzp-value: 0.02t-test, 1 sided
Comparison: ST36 100Hz compared to PC6 100Hzp-value: 0.11t-test, 1 sided
Comparison: ST36 100Hz compared to PC6 25Hzp-value: 0.01t-test, 1 sided
Comparison: ST36 100Hz compared to Shamp-value: 0.04t-test, 1 sided
Comparison: ST36 25Hz compared to PC6 100Hzp-value: 0.11t-test, 1 sided
Comparison: ST36 25Hz compared to PC6 25Hzp-value: 0.23t-test, 1 sided
Comparison: ST36 25Hz compared to Shamp-value: 0.17t-test, 1 sided
Comparison: PC6 100Hz compared to PC6 25Hzp-value: 0.15t-test, 1 sided
Comparison: PC6 100Hz compared to Shamp-value: 0.43t-test, 1 sided
Comparison: PC6 25Hz compared to Shamp-value: 0.19t-test, 1 sided
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in max vol per participant in mL of the rectum during ST36 100Hz minus max vol at baseline | -2.31 mL | Standard Error 13.59 |
| Subjects With IBS-C | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in max vol per participant in mL of the rectum during ST36 25Hz minus max vol at baseline | 14.08 mL | Standard Error 8.74 |
| Subjects With IBS-C | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in max vol per participant in mL of the rectum during PC6 100Hz minus max vol at baseline | 11.83 mL | Standard Error 8.1 |
| Subjects With IBS-C | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in max vol per participant in mL of the rectum during PC6 25Hz minus max vol at baseline | -1.56 mL | Standard Error 10.01 |
| Subjects With IBS-C | Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Change in max vol per participant in mL of the rectum during sham minus max vol at baseline | 13.48 mL | Standard Error 8.75 |
Comparison: Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baselinep-value: 0.87t-test, 2 sided
Comparison: Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baselinep-value: 0.13t-test, 2 sided
Comparison: Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baselinep-value: 0.17t-test, 2 sided
Comparison: Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baselinep-value: 0.88t-test, 2 sided
Comparison: Change in maximum volume in mL of the rectum during sham when compared to baselinep-value: 0.14t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | ST36 100Hz | -7.74 score on a scale | Standard Error 1.82 |
| Subjects With IBS-C | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | ST36 25Hz | -0.94 score on a scale | Standard Error 2.84 |
| Subjects With IBS-C | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | PC6 100Hz | -4.19 score on a scale | Standard Error 2.41 |
| Subjects With IBS-C | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | PC6 25Hz | -2.23 score on a scale | Standard Error 1.87 |
| Subjects With IBS-C | Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration. | Sham | -3.74 score on a scale | Standard Error 1.77 |
Comparison: ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulationp-value: 0.00046998t-test, 2 sided
Comparison: ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulationp-value: 0.74369428t-test, 2 sided
Comparison: PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulationp-value: 0.09854383t-test, 2 sided
Comparison: PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulationp-value: 0.24872746t-test, 2 sided
Comparison: Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulationp-value: 0.04828889t-test, 2 sided
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.
Time frame: 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.
Population: In the case of PC6 100 HZ, post-treatment value is missing for 1 participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With IBS-C | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | ST36 100Hz | 5.79 mmHg | Standard Error 1.88 |
| Subjects With IBS-C | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | ST36 25Hz | 0.26 mmHg | Standard Error 1.18 |
| Subjects With IBS-C | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | PC6 100Hz | 1.87 mmHg | Standard Error 0.97 |
| Subjects With IBS-C | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | PC6 25Hz | 6.05 mmHg | Standard Error 1.82 |
| Subjects With IBS-C | Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. | Sham | 2.63 mmHg | Standard Error 1.29 |
Comparison: Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baselinep-value: 0.007t-test, 2 sided
Comparison: Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baselinep-value: 0.83t-test, 2 sided
Comparison: Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baselinep-value: 0.87t-test, 2 sided
Comparison: Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baselinep-value: 0.004t-test, 2 sided
Comparison: Change in first sensation in mmHg of the rectum during sham when compared to baselinep-value: 0.056t-test, 2 sided