Adults 18 to 99, any sex, with IBS or Constipation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.Primary· 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 estab
Change in avg max tolerance per person: value at ST36 100Hz minus value at that day's baseline
Group
Value
95% CI
Subjects With IBS-C
0.79
± 1.80
Change in avg max tolerance per person: value at ST36 25Hz minus value at that day's baseline
Group
Value
95% CI
Subjects With IBS-C
1.32
± 2.26
Change in avg max tolerance per person: value at PC6 100Hz minus value at that day's baseline
Group
Value
95% CI
Subjects With IBS-C
-4.44
± 2.45
Change in avg max tolerance per person: value at PC6 25Hz minus value at that day's baseline
Group
Value
95% CI
Subjects With IBS-C
-4.21
± 3.40
Change in avg max tolerance per person: value at sham minus value at that day's baseline
Group
Value
95% CI
Subjects With IBS-C
1.84
± 1.03
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities.Primary· 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 participa
Change in avg max tolerance per person: value at ST36 100Hz minus value at ST36 25Hz
Group
Value
95% CI
Subjects With IBS-C
-0.53
± 2.03
Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
-1.66
± 1.04
Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
5.00
± 2.60
Change in avg max tolerance per person: value at ST36 100Hz minus value at sham
Group
Value
95% CI
Subjects With IBS-C
-1.05
± 1.42
Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
-1.13
± 1.26
Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
5.53
± 2.83
Change in avg max tolerance per person: value at ST36 25Hz minus value at sham
Group
Value
95% CI
Subjects With IBS-C
-0.53
± 1.64
Change in avg max tolerance per person: value at PC6 100Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
6.66
± 1.84
Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration.Secondary· 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 ea
ST36 100Hz
Group
Value
95% CI
Subjects With IBS-C
-7.74
± 1.82
ST36 25Hz
Group
Value
95% CI
Subjects With IBS-C
-0.94
± 2.84
PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
-4.19
± 2.41
PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
-2.23
± 1.87
Sham
Group
Value
95% CI
Subjects With IBS-C
-3.74
± 1.77
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.Secondary· 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 rand
Change in VAS per person: value at ST36 100Hz minus value at ST36 25Hz
Group
Value
95% CI
Subjects With IBS-C
-6.80
± 2.33
Change in VAS per person: value at ST36 100Hz minus value at PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
-3.55
± 2.11
Change in VAS per person: value at ST36 100Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
-5.51
± 1.84
Change in VAS per person: value at ST36 100Hz minus value at Sham
Group
Value
95% CI
Subjects With IBS-C
-3.99
± 1.79
Change in VAS per person: value at ST36 25Hz minus value at PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
3.25
± 2.62
Change in VAS per person: value at ST36 25Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
1.29
± 2.35
Change in VAS per person: value at ST36 25Hz minus value at Sham
Group
Value
95% CI
Subjects With IBS-C
2.80
± 2.30
Change in VAS per person: value at PC6 100Hz minus value at PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
-1.96
± 2.14
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.Secondary· 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. E
Change in max vol per participant in mL of the rectum during ST36 100Hz minus max vol at baseline
Group
Value
95% CI
Subjects With IBS-C
-2.31
± 13.59
Change in max vol per participant in mL of the rectum during ST36 25Hz minus max vol at baseline
Group
Value
95% CI
Subjects With IBS-C
14.08
± 8.74
Change in max vol per participant in mL of the rectum during PC6 100Hz minus max vol at baseline
Group
Value
95% CI
Subjects With IBS-C
11.83
± 8.10
Change in max vol per participant in mL of the rectum during PC6 25Hz minus max vol at baseline
Group
Value
95% CI
Subjects With IBS-C
-1.56
± 10.01
Change in max vol per participant in mL of the rectum during sham minus max vol at baseline
Group
Value
95% CI
Subjects With IBS-C
13.48
± 8.75
Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.Secondary· 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
ST36 100Hz
Group
Value
95% CI
Subjects With IBS-C
5.79
± 1.88
ST36 25Hz
Group
Value
95% CI
Subjects With IBS-C
0.26
± 1.18
PC6 100Hz
Group
Value
95% CI
Subjects With IBS-C
1.87
± 0.97
PC6 25Hz
Group
Value
95% CI
Subjects With IBS-C
6.05
± 1.82
Sham
Group
Value
95% CI
Subjects With IBS-C
2.63
± 1.29
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 16 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04953728.