UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062263 |
|---|---|
| Receipt number | R000071249 |
| Scientific Title | Efficacy and Safety of Passive Joint Movement in Patients with Functional Dyspepsia: A Single-Arm Pre-Post Pilot Study |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 03:10:19 |
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Basic information
Public title
Passive Joint Movement in Patients with Functional Dyspepsia: A Single-Arm Pre-Post Pilot Study
Acronym
FD-PJM Study
Scientific Title
Efficacy and Safety of Passive Joint Movement in Patients with Functional Dyspepsia: A Single-Arm Pre-Post Pilot Study
Scientific Title:Acronym
FD-PJM Study
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the total Frequency Scale for the Symptoms of GERD (FSSG) score from baseline to after the Passive Joint Movement (PJM) intervention.
Key secondary outcomes
Changes in the acid reflux and dysmotility symptom subscores of the FSSG, changes in Hospital Anxiety and Depression Scale (HADS) scores, changes in heart rate variability parameters including HF, LF/HF, and CVRR, and the incidence of intervention-related adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoteru |
| Middle name | |
| Last name | Miyata |
Organization
Miyata Gastroenterology and Dermatology Clinic
Division name
Department of Gastroenterology
Zip code
1710031
Address
MOMO Building 2F, 1-11-2 Hyakunincho, Shinjuku-ku, Tokyo
TEL
0359370668
bluebirdmiyata@gmail.com
Public contact
Name of contact person
| 1st name | Naoteru |
| Middle name | |
| Last name | Miyata |
Organization
Miyata Gastroenterology and Dermatology Clinic
Division name
Department of Gastroenterology
Zip code
1710031
Address
MOMO Building 2F, 1-11-2 Hyakunincho, Shinjuku-ku, Tokyo
TEL
0359370668
Homepage URL
bluebirdmiyata@gmail.com
Sponsor or person
Institute
Miyata Gastroenterology and Dermatology Clinic
Institute
Department
Personal name
Naoteru Miyata, MD, PhD
Funding Source
Organization
Yurashi International Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International Society for Geriatrics and Gerontology Ethics Committee
Address
Room 702, Kyorin Building, 4-2-1 Yushima, Bunkyo-ku, Tokyo 113-0034, Japan
Tel
03-3814-8604
maeda@med-pla.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
宮田胃腸内科皮膚科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
Results
Fourteen patients were enrolled and 11 were analyzed. After four PJM sessions, FSSG and dyspepsia scores significantly improved (p=0.010 and p=0.014). PHQ-9 and STAI-State also improved. Resting HRV did not significantly change, but baseline ccvHF, ccvLF, and CVRR correlated positively with symptom improvement, whereas LF/HF correlated negatively. No serious adverse events occurred.
Results date posted
| 2026 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
| 2026 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 03 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071249
