UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047746 |
|---|---|
| Receipt number | R000054429 |
| Scientific Title | Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis |
| Date of disclosure of the study information | 2022/05/13 |
| Last modified on | 2025/05/19 12:52:28 |
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Basic information
Public title
Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Acronym
Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Scientific Title
Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Scientific Title:Acronym
Phase angle is related to physical function and quality of life in preoperative patients with lumbar spinal stenosis
Region
| Japan |
Condition
Condition
lumbar spinal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between Phase angle and physical function and quality of life in patients with lumbar spinal canal stenosis.
Basic objectives2
Others
Basic objectives -Others
Investigate physical function and quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle(Preoperative measurements)
Key secondary outcomes
handgrip strength, walking speed, timed up and go test, Life Space Assessment, Prognostic Nutritional Index, Japanese Orthopaedic Association back pain evaluation questionnaire, EQ-5D
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years of age who were admitted to the Department of Orthopedic Surgery of Kurume University Hospital for surgery for a diagnosis of lumbar spinal canal stenosis between May 2020 and February 2022 are eligible for the study.
Key exclusion criteria
Patients with a history of pyogenic spondylitis, metastatic bone tumor, or stroke.
Patients who have difficulty standing up due to hemiplegia, etc. and have difficulty in body composition measurement.
Patients with a pacemaker inserted.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Otsubo |
Organization
Kurume University Hospital
Division name
Rehabilitation Department
Zip code
830-0011
Address
67 Asahi town, Kurume city, Fukuoka
TEL
0942353311
ohtsubo_ryouta@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Ohtsubo |
Organization
Kurume University Hospital
Division name
Rehabilitation Department
Zip code
830-0011
Address
67 Asahi town, Kurume city, Fukuoka
TEL
0942353311
Homepage URL
ohtsubo_ryouta@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Hospital Rehabilitation Department
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Kurume University
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
Kurume University Medical Ethics Committee
Address
67 Asahi town, Kurume city, Fukuoka
Tel
0942317917
i_rinri@kurume-u.ac.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 | 05 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.hosp.kurume-u.ac.jp/medical/section/crc/crc_gpub/optout/medical/22017.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37626144/
Number of participants that the trial has enrolled
250
Results
Phase angle in patients with lumbar spinal canal stenosis is related to physical function and quality of life and may be a new tool used to understand the patient profile.
Results date posted
| 2025 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients over 20 years of age who were admitted to the Department of Orthopedic Surgery of Kurume University Hospital for surgery for a diagnosis of lumbar spinal canal stenosis between May 2020 and February 2022 are eligible for the study.
Participant flow
There is no special process for the study because it is a retrospective study using data obtained in a regular medical practice.
Adverse events
No adverse events
Outcome measures
Phase angle, Hand grip strength, walking speed, TUG, EQ-5D, JOABPEQ, GLFS-25, LSA, PNI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective, observational study, and the study will be conducted on cases from May 2020 to February 2022.
Management information
Registered date
| 2022 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054429
