Ulcerative Colitis
Conditions
Brief summary
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Interventions
DEVICEtranscutaneous electrical acustimulation at treatment sites
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk.
DEVICEtranscutaneous electrical acustimulation at sham sites
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Ulcerative colitis diagnosed for at least 3 mouths. 3. Mayo score 4-10, Mayo endoscopic score 2-3 points 4. Resistant to at least one type of medical treatments
Exclusion criteria
1. Treatment-naive ulcerative colitis (no previous treatment) 2. Acute severe ulcerative colitis 3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis 4. Other systemic diseases 5. Pregnancy and lactation 6. Allergic to the electrode patch
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 8 weeks | decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission | 8 weeks | defined as Mayo endoscopic score ≤ 1 |
| Clinical remission | 8 weeks | overall score ≤2 \[and no individual subscore \>1\] |
| Symptomatic remission | 2, 4, 6, and 8 weeks | Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0 |
| Fecal calprotectin | 4 and 8 weeks | fecal sample |
| erythrocyte sedimentation rate | 4 and 8 weeks | blood sample |
| C reactive protein | 4 and 8 weeks | blood sample |
| pancreatic polypeptide | 4 and 8 weeks | blood sample |
| Change from baseline in the Mayo score | 8 weeks | Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome. |
| acetyl choline | 4 and 8 weeks | blood sample |
| alpha7 nicotinic acetylcholine receptor | 8 weeks | Intestinal mucosal tissue sample |
| Inflammatory Bowel Disease Questionnaire Score | 4 and 8 weeks | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome |
| Hospital Anxiety and Depression scale score | 4 and 8 weeks | anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome. |
| Pittsburgh sleep quality index | 4 and 8 weeks | The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome. |
| autonomic profile characteristics | 4 and 8 weeks | heart rate variability indicating sympathetic and parasympathetic activity |
| norepinephrine | 4 and 8 weeks | blood sample |
Countries
China
Contacts
Primary ContactJian Wan
Outcome results
None listed