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Home Transcutaneous Electrical Acustimulation (TEA)

ConditionIrritable Bowel Syndrome With Constipation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)

Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period

Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis.

Abdominal pain is not adequately relieved at the time of screening and the time of randomization.

Disqualifiers

Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.

Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation.

Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study

A history of abdominal surgery (other than cholecystectomy or appendectomy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TEA

    Device

    The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.

  • Lexapro

    Drug

    This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: TEA at location AExperimental treatment 1 intervention
Group B: TEA at location BSham comparator 1 intervention
Group C: TEA at location CExperimental treatment 1 intervention
Group D: Escitalopram treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey

Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.

Time frame
Daily for 14 weeks
2

Change in global abdominal pain

Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied). These answers will be compared from week 1 to week 14.

Time frame
Weekly for 14 weeks

Secondary outcomes

1

Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey

A self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. This survey is 34 questions, all scored from 1 to 5, with 1 being the lowest (not at all) and 5 being the highest (a great deal, or extremely). The individual responses to the 34 items are summed and averaged for a total score. These answers will be compared from week 0 to week 14

Time frame
Weekly for 14 weeks
2

Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety

Determines levels of anxiety that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14

Time frame
Weekly for 14 weeks
3

Change in Hospital Anxiety and Depression Scale (HADS) - Depression

Determines levels of depression that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14

Time frame
Weekly for 14 weeks
4

Change in IBS - Symptom Severity Score (IBS-SSS)

A survey designed to record and monitor the severity of IBS. The maximum achievable score was 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively. Scores will be compared from day 10 to day 90

Time frame
Once every 10 days for 14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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