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Electroacupuncture for Gastroparesis (TEA Trial)
TEA Trial Summary
This trial studies whether transcutaneous electroacupuncture is effective in treating patients with functional dyspepsia, gastroparesis, or chronic constipation.
TEA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEA Trial Design
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Who is running the clinical trial?
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- People between 18 and 80 years old, regardless of gender.You have a heart device implanted in your body.You are currently taking medicines that affect how your stomach and intestines work.People between 18 and 80 years old, regardless of gender.You have recently had tests showing slow movement of food through your intestines or abnormal muscle movement in your colon.You have a history of stomach bezoar or diverticulitis.You have very strong daily stomach pain that needs strong painkillers.You have had surgery on your stomach or intestines.You are likely to follow the study rules and finish the study.You are between 18 and 80 years old.People with diabetesYou are allergic to the solution used to clean your skin before a procedure.You experience uncomfortable fullness after eating.You have been experiencing feelings of fullness after eating a little, stomach pain, or burning in the upper stomach for the past 3 months.You don't have any visible signs of disease in your upper digestive system that could explain your symptoms.You often feel uncomfortably full after eating.You have felt full quickly or had stomach pain or burning in the last 3 months.You have received acupuncture treatment or know about acupuncture points.You have had surgery on your stomach or esophagus in the past.You have either a serious stomach problem or two moderate stomach problems.You have been diagnosed with slow stomach emptying in the past year.You meet the specific criteria for diagnosing constipation according to the Rome IV guidelines.You had an upper endoscopy or upper GI test in the past 2 years, and it didn't show any signs of certain stomach issues like bezoars, strictures, or peptic ulcers.Inclusion Criteria: People who have chronic constipation.
- Group 1: Sham-TEA and then TEA ST36 and PC6
- Group 2: TEA at ST36 and PC6 first and then sham TEA
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What goals is this research endeavor trying to accomplish?
"This clinical trial's primary outcome, assessed over a 10-week period, will be the alteration in Patient Assessment of Constipation (PAC-SYN) scores. Additionally, secondary objectives include assessing changes to quality of life with Short Form (SF-36v2) Health Survey results; shifts in electrogastrogram gastric slow waves and R - R intervals as measures for gastrointestinal rhythmicity and cardiac electrical activity respectively. The SF-36v2 is an evaluation comprised of thirty six questions that yields two aggregate scores representing physical health and mental wellbeing along with eight subscales: vitality, bodily pain & general health perceptions; physical role functioning"
Does this clinical trial accept individuals aged 50 or older as participants?
"To be considered for this medical trial, individuals must range between 18 and 80 in age. There are additionally 4 studies open to minors and 27 trials which cater to those aged 65 or above."
Is participation in this research endeavor open to the public?
"This clinical trial is seeking 120 participants who have been diagnosed with gastroparesis and are between 18-80 years old."
Is recruitment for this trial currently ongoing?
"This clinical trial, which was originally made public on October 1st 2020, is actively recruiting patients according to data provided by clinicaltrials.gov. With the most recent update being published in March 8th 2022, it appears that this study is still open and seeking participants."
What is the current number of participants in this research endeavor?
"Affirmative, the clinicaltrials.gov portal displays that this research project is presently engaging potential candidates. The investigation was first published on October 1st 2020 and its latest alterations were made on March 8th 2022. It currently seeks 120 participants from a single location."
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