UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047111 |
|---|---|
| Receipt number | R000053719 |
| Scientific Title | Examination of nerve block effect on abdominal pain and low back pain in Parkinson's disease |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2025/04/21 07:40:18 |
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Basic information
Public title
Examination of nerve block effect on abdominal pain and low back pain in Parkinson's disease
Acronym
Effect of nerve block on Parkinson's disease
Scientific Title
Examination of nerve block effect on abdominal pain and low back pain in Parkinson's disease
Scientific Title:Acronym
Effect of nerve block on Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with Parkinson's disease who complain of chronic abdominal pain and low back pain, block injection and trigger point injection to the anterior cutaneous nerve will be performed to evaluate the effect on pain and the effect on Parkinson's symptoms including posture abnormalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Questionnaire including visual analogue scale
(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after the block injection)
Key secondary outcomes
Unified Parkinson Disease Rating Scale, functional evaluation in rehabilitation, evaluation of waist bending angle
(2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after the block injection)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with Parkinson's disease by the British Brain Bank Clinical Criteria
2) H & Y classification II degree or higher
3) Patients aged between 20 and 85 at the time of consent
4) Gender does not matter
5) Patients who have voluntarily consented to the document
Key exclusion criteria
1) Patients with serious physical symptoms other than Parkinson's disease (cardiac / hepatic / renal dysfunction, hematopoietic disorders, etc.)
2) Viral hepatitis: HBsAg positive or HCV antibody positive
3) Women who are pregnant or may become pregnant
4) Patients with a history of hypersensitivity to the study drug
5) Patients with drug addiction / alcohol dependence
6) Patients with serious psychiatric symptoms (confusion, hallucinations, delusions, abnormal behavior, etc.) within 3 months before obtaining the consent form
7) Other patients who the doctor in charge deems inappropriate to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuyuki |
| Middle name | |
| Last name | Endo |
Organization
Osaka Toneyama Medical Center
Division name
Neurology
Zip code
565-0873
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
+81-6-6853-2001
endo.takuyuki.gr@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takuyuki |
| Middle name | |
| Last name | Endo |
Organization
Osaka Toneyama Medical Center
Division name
Neurology
Zip code
565-0873
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
+81-6-6853-2001
Homepage URL
endo.takuyuki.gr@mail.hosp.go.jp
Sponsor or person
Institute
Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of
Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Toneyama Medical Center Clinical Research Review Committee
Address
5-1-1, Toneyama, Toyonaka, Osaka
Tel
06-6853-2001
410-chiken@mail.hosp.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 07 | 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
10
Results
Results date posted
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation period, 24 weeks
Inspection items
Background of research subjects
Diagnostic imaging
Chest X-ray, thoracolumbar MRI
Clinical examination
Hematological tests
electrocardiogram
Questionnaire for anesthesiology pain clinic
Evaluation of neurological symptoms
Evaluation in the rehabilitation department, 10m walking, 3m Time-up-go test
Pain Visual Analogue Scale, photos for posture evaluation
Management information
Registered date
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053719
