Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062263) titled 'Passive Joint Movement in Patients with Functional Dyspepsia: A Single-Arm Pre-Post Pilot Study' on July 17.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Miyata Gastroenterology and Dermatology Clinic
Condition:
Condition - Functional Dyspepsia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the efficacy and safety of Passive Joint Movement (PJM) in patients with functional dyspepsia and to investigate its effects on gastrointestinal symptoms, psychological symptoms, and autonomic nervous system-related parameters.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Passive Joint Movement (PJM)
Participants receive standardized Passive Joint Movement (PJM), a manual therapy consisting of rhythmic passive movements applied to the major joints of the upper limbs, lower limbs, and trunk by a trained therapist according to a predefined protocol. Outcomes are evaluated before and after the intervention.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Adults aged 20 years or older.
Patients diagnosed with functional dyspepsia according to the Rome IV criteria.
Patients in whom organic gastrointestinal diseases have been excluded by upper gastrointestinal endoscopy and other appropriate examinations.
Patients who provided written informed consent.
Key exclusion criteria - 1.Patients with organic gastrointestinal diseases (e.g., gastric cancer or peptic ulcer) identified by upper gastrointestinal endoscopy or other appropriate examinations.
2.Patients with a history of gastrointestinal surgery that may affect the evaluation of functional dyspepsia.
3.Patients with severe cardiovascular, respiratory, hepatic, or renal diseases.
4.Patients with severe psychiatric disorders or cognitive impairment that would interfere with study participation.
5.Pregnant or breastfeeding women.
6.Patients considered unsuitable for participation by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 09 Month 03 Day
Date of IRB - 2024 Year 09 Month 09 Day
Anticipated trial start date - 2025 Year 02 Month 25 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071249
Disclaimer: Curated by HT Syndication.