UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057882 |
|---|---|
| Receipt number | R000066140 |
| Scientific Title | The Effect of Advanced Multistage Exercise Load-Based Physical Therapy After Lumbar Spinal Canal Stenosis Surgery |
| Date of disclosure of the study information | 2025/05/16 |
| Last modified on | 2025/05/16 09:51:48 |
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Basic information
Public title
The Effect of Advanced Multistage Exercise Load-Based Physical Therapy After Lumbar Spinal Canal Stenosis Surgery
Acronym
Clinical trials on lumbar spinal canal stenosis
Scientific Title
The Effect of Advanced Multistage Exercise Load-Based Physical Therapy After Lumbar Spinal Canal Stenosis Surgery
Scientific Title:Acronym
Clinical trials on lumbar spinal canal stenosis
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare how the following factors differ between patients who underwent a conventional rehabilitation program and those who received patient education based on pain neuroscience along with the Asaka Method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
ODI(Oswestry Disability Index), Asaka Original Questionnaire, EQ-5D5L
The evaluation timing for each item will be set as preoperative, postoperative day 3, postoperative day 6, postoperative day 9, and (postoperative day 12) for lumbar spinal canal stenosis.
Key secondary outcomes
Hip flexion and extension range of motion, isometric knee extension muscle strength, ASIA(American Spinal Injury Association) impairment scale, pain assessed by the Visual Analog Scale (VAS), four items of the Functional Balance Scale (FBS) (360 rotation, step-over, standing balance in tandem stance, single-leg standing balance), 10-meter maximum walking time, and Barthel Index (BI).
The evaluation timing for each item will be set as preoperative, postoperative day 3, postoperative day 6, postoperative day 9, and (postoperative day 12) for lumbar spinal canal stenosis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patient education based on pain neuroscience and the Asaka Method.
Interventions/Control_2
Traditional rehabilitation program.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients diagnosed with spinal canal stenosis at our hospital who undergo surgery and rehabilitation.
Key exclusion criteria
(A) Individuals with postoperative complications such as infections, thrombosis, or bleeding
(B) Individuals with serious illnesses such as cardiovascular diseases or respiratory diseases
(C) Individuals who cannot undergo standard rehabilitation due to dementia or other mental disorders, requiring a surrogate decision-maker
(D) Individuals who lack the motivation to participate in rehabilitation
(E) Individuals unable to participate in a rehabilitation program for any reason
(F) Individuals who do not consent to research participation
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Watanabe |
Organization
TMG Asaka Medical Center
Division name
The Department of Rehabilitation
Zip code
3510023
Address
1340-1, Mizonuma, Asaka City, Saitama Prefecture, Japan
TEL
0570072055
h_watanabe2@tmg.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Watanabe |
Organization
TMG Asaka Medical Center
Division name
The Department of Rehabilitation
Zip code
351-0023
Address
1340-1, Mizonuma, Asaka City, Saitama Prefecture, Japan
TEL
0570072055
Homepage URL
https://www.asakadai-hp.jp/reha/effort/cat/
h_watanabe2@tmg.or.jp
Sponsor or person
Institute
TMG Asaka Medical Center
Institute
Department
Personal name
Hiroyuki Watanabe
Funding Source
Organization
None
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
TMG Asaka Medical Center
Address
1340-1, Mizonuma, Asaka City, Saitama Prefecture, Japan
Tel
0570072055
h_watanabe2@tmg.or.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
TMGあさか医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066140
