New Physitherapy or Alternative Therapy for Hiccup
HICCUP
Comparison of New pHysIotherapy With Alternative Therapy for Clinical outComes in Patients With hiccUP: Rationale and Design of a Randomized Clinical Trail
1 other identifier
interventional
60
1 country
1
Brief Summary
Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. For some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. Acupuncture is also effective for some patients. Surgical treatment may be required for some clinically intractable hiccups. However, for the above interventions or treatment means, the current efficacy still needs to be improved. In the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. To further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 3, 2023
February 1, 2023
10 months
February 18, 2023
March 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the rate of termination of hiccup in 30 seconds
the rate of termination of hiccup in 30 seconds
1 year
the time course from the start of therapy to the end of hicuup
the time course from the start of therapy to the end of hicuup
1 year
Study Arms (2)
physiotherapy
EXPERIMENTALNew physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water.
alternative therapy
PLACEBO COMPARATORAlternative therapy: including routine physical therapy such as suffocation and drinking cold water, as well as drug therapy such as metoclopramide and Mianna.
Interventions
New physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Able to swallow water
You may not qualify if:
- Allergy or contraindication to the following drugs: metoclopramide et al
- Severe choking on water and difficulty swallowing were present
- Impaired consciousness and inability to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shen Jian
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2023
First Posted
March 1, 2023
Study Start
March 1, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 3, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share