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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000047746 |
Receipt No. | 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 | 2022/05/13 |
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 |
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Condition | ||
Condition | lumbar spinal stenosis | |
Classification by specialty |
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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 | |
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Interventions/Control_4 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kurume University Hospital Rehabilitation Department |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 250 |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054429 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
2022/05/13 | 分析用 データシート.xlsx |
Research case data | |
Registered date | File name |
2022/05/13 | 分析用 データシート.xlsx |