UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062880 |
|---|---|
| Receipt number | R000071994 |
| Scientific Title | Experiences with the Acute Postoperative Recovery Process in Patients Who Have Undergone Surgery for Lumbar Spinal Stenosis: A Mixed-Methods Study |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/10 23:11:25 |
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Basic information
Public title
Experiences with the Acute Postoperative Recovery Process in Patients Who Have Undergone Surgery for Lumbar Spinal Stenosis
Acronym
Experiences with the Recovery Process in Patients Following Surgery for Lumbar Spinal Stenosis
Scientific Title
Experiences with the Acute Postoperative Recovery Process in Patients Who Have Undergone Surgery for Lumbar Spinal Stenosis: A Mixed-Methods Study
Scientific Title:Acronym
Experiences with the Acute Postoperative Recovery Process in Patients Who Have Undergone Surgery for Lumbar Spinal Stenosis
Region
| Japan |
Condition
Condition
Lumbar Spinal Stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the perioperative recovery process by combining patients perioperative experiences following surgery for lumbar spinal stenosis with changes in their physical function before and after surgery.
Basic objectives2
Others
Basic objectives -Others
Although it is generally accepted that physical therapy administered over a 3-month period following surgery is effective in reducing pain and improving activities of daily living (ADL) in patients with lumbar spinal stenosis, there are few reports on studies combining quantitative and qualitative data. Therefore, this study aims to clarify changes in physical function and quality of life (QOL) before and after surgery in patients with lumbar spinal stenosis by examining their perioperative experiences.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative data obtained from interviews
Key secondary outcomes
Numerical Rating Scale, Zurich Claudication Questionnaire, Roland-Morris Disability Questionnaire, Euro Qol-5 Dimension-5level, 10m walking test, Short physical performance battery
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
Individuals aged 40 or older who have been diagnosed with lumbar spinal stenosis and have undergone spinal fusion surgery on the lumbar spine
Key exclusion criteria
Individuals with conditions such as kyphosis that affect the thoracic spine
Individuals with a history of spinal surgery or spinal disorders
Individuals suffering from dementia or mental disorders
Individuals who have experienced postoperative complications
Individuals unable to walk more than 10 meters
Individuals suffering from central nervous system disorders or peripheral neuropathy
Target sample size
34
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
reha-nakamura@sanraku.or.jp
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
Nothing
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
Address
2-5, kanda-surugadai, Chiyoda-ku, Tokyo
Tel
03-3292-3981
reha-nakamura@sanraku.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-3
Org. issuing International ID_1
Sanraku Hospital Clinical Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三楽病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The questionnaire survey will include the Numerical Rating Scale to measure pain intensity; the Zurich Claudication Questionnaire to assess quality of life related to neurological symptoms of lumbar spinal stenosis; the Roland-Morris Disability Questionnaire to assess QOL related to low back pain; and the EuroQol-5D5L to measure health-related QOL. Physical function assessments will include the 10-meter walk test to measure walking speed and the Short Physical Performance Battery to comprehensively assess balance, gait, and muscle strength.
The interview survey will be conducted by the principal investigator using a semi-structured interview following the quantitative survey at 2 weeks post-surgery to investigate participants experiences during the postoperative recovery process.
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071994
