Pilot Study Investigating the Effect of Tai Chi as Treatment for IBS-C
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome With Constipation
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- IBS Symptom Severity Score at 12 Weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).
Detailed Description
This is a single-center pilot study investigating the efficacy of Tai Chi practice in reducing symptoms of IBS. The investigators hope that subjects practicing Tai Chi will have reduced symptoms of IBS-C as measured through overall global symptom relief as well as the IBS-SSS, IBS-QOL, VSI, HADS, Visual Analogue Pain Scale, and changes in bloating, abdominal pain, abdominal distention, and constipation severity. The study will also use daily entries made through the GeoPain app to record trends in pain intensity.
Investigators
Kyle Staller, MD, MPH
Assistant Professor in Medicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
IBS Symptom Severity Score at 12 Weeks
Time Frame: At final study visit, 12 weeks.
Questionnaire involves yes/no questions, entering numbers, rating scales from 0 to 100, and marking locations of pain. No subscales. Total score is derived by multiplying the number of days of pain (0 to 10) by 10 and summing it with the value from each of 4 scales (0 to 100). Higher total score represents greater symptom severity (min score= 0, max score= 500).
Secondary Outcomes
- Likelihood of Continuing Treatment(Recorded at final study visit (following 8 weeks of treatment))
- Treatment Satisfaction(Recorded at final study visit (following 8 weeks of treatment))
- IBS Quality of Life (IBS-QOL) at 12 Weeks(At final study visit, 12 weeks)
- Daily Bowel Movement Frequency at 12 Weeks(At final study visit, 12 weeks.)
- Bloating Scale Score at 12 Weeks(At final study visit, 12 weeks)
- Abdominal Discomfort Scale Score at 12 Weeks(At final study visit, 12 weeks.)
- Constipation Severity Scale Score at 12 Weeks(At final study visit, 12 weeks.)
- Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks(At final study visit, 12 weeks.)
- Visceral Sensitivity Index (VSI) Score at 12 Weeks(At final study visit, 12 weeks)
- Stool Microbiome(Change from baseline to final visit. Through study completion, up to 18 weeks)
- Global Assessment of Relief at 12 Weeks(At final study visit, 12 weeks)