UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060432 |
|---|---|
| Receipt number | R000069136 |
| Scientific Title | The Effect of Preoperative Trunk Muscle Cross-sectional Area on Temporal Changes in Pain and Quality of Life Following Spinal Fusion Surgery |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 23:03:13 |
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Basic information
Public title
The Effect of Preoperative Trunk Muscle Mass on Postoperative Spinal Surgery Pain and Daily Living
Acronym
The Effect of Preoperative Trunk Muscle Mass on Postoperative Spinal Surgery Pain and Daily Living
Scientific Title
The Effect of Preoperative Trunk Muscle Cross-sectional Area on Temporal Changes in Pain and Quality of Life Following Spinal Fusion Surgery
Scientific Title:Acronym
The Effect of Preoperative Trunk Muscle Cross-sectional Area on Temporal Changes in Pain and Quality of Life Following Spinal Fusion Surgery
Region
| Japan |
Condition
Condition
Lumbar Spinal Stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of trunk muscle cross-sectional area on postoperative pain and temporal changes in QOL in patients with lumbar spinal stenosis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psoas muscle index
Key secondary outcomes
Numerical Rating Scale, Zurich Claudication Questionnaire,Roland-Morris Disability Questionnaire, EuroQol-5 Dimension-5level, Presence of Outpatient Physical Therapy
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lumbar Spinal Stenosis
Key exclusion criteria
Individuals with conditions such as scoliosis affecting the thoracic spine
Individuals with a history of spinal surgery or spinal disorders
Individuals suffering from dementia or mental illness
Individuals who developed postoperative complications
Individuals discharged to a location other than their home
Individuals unable to walk 10 meters or more
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Nakamura |
Organization
Sanraku Hospital
Division name
Rehabilitation room
Zip code
101-8326
Address
2-5, kanda-surugadai, Chiyoda-ku, Tokyo
TEL
03-3292-3981
nkmrtkm1625aauaaui@icloud.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Nakamura |
Organization
Sanraku Hospital
Division name
Rehabilitation room
Zip code
101-8326
Address
2-5, kanda-surugadai, Chiyoda-ku, Tokyo
TEL
03-3292-3981
Homepage URL
nkmrtkm1625aauaaui@icloud.com
Sponsor or person
Institute
Sanraku Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanraku Hospital
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
Sanraku Hospital Clinical Ethics Committee
Address
2-5, kanda-surugadai, Chiyoda-ku, Tokyo
Tel
03-3292-3981
nkmrtkm1625aauaaui@icloud.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-2
Org. issuing International ID_1
Sanraku Hospital Clinical Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 21 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069136
