UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037826 |
|---|---|
| Receipt number | R000043113 |
| Scientific Title | Efficacy of therapeutic exercise in patients with lumbar spinal stenosis |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2024/08/15 13:59:57 |
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Basic information
Public title
Efficacy of therapeutic exercise in patients with lumbar spinal stenosis
Acronym
Efficacy of therapeutic exercise in patients with lumbar spinal stenosis
Scientific Title
Efficacy of therapeutic exercise in patients with lumbar spinal stenosis
Scientific Title:Acronym
Efficacy of therapeutic exercise in 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 effect of dynamic exercise therapy for patients with lumbar spinal canal stenosis in a multicenter prospective study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS
Oswestry Disability Index Score
LSS specific symptom scale and QOL scale
Baseline,1 month,2month
Key secondary outcomes
five times sit-to-stand test
muscle power:abdominal muscle,back muscle,Hip flexsor and extensor
Range of motion:Hip
Satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
stretch/muscle/aerobic exercise
Interventions/Control_2
stretch exercise
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis:lumbar spinal stenosis
Key exclusion criteria
Cauda equina type
History of spine surgery
Cognitive impairment
stroke
Brain tumor
Opioid medication
osteoporosis
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | EIKI |
| Middle name | |
| Last name | TUSHIMA |
Organization
Hirosaki University Graduate School of Health Sciences
Division name
Department of Comprehensive Rehabilitation Science
Zip code
036-8564
Address
66-1,HIROSAKISHI HONTYOU,HIROSAKI CITY,AOMORIKEN
TEL
0172-33-5111
pteiki@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | KAZUHIRO |
| Middle name | |
| Last name | ISHIDA |
Organization
WAJOKAI ENIWA HOSPITAL
Division name
department of rehabilitation
Zip code
061-1449
Address
2-1-1,koganetyuuou,Eniwa City,HOKKAIDO
TEL
0123-33-2333
Homepage URL
reha@eniwa-hosp.com
Sponsor or person
Institute
Hirosaki University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Musculoskeletal Physical Therapy
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
Institutional Review Board of Hirosaki University Graduate School of Health Sciences
Address
66-1,HIROSAKISHI HONTYOU,HIROSAKI CITY,AOMORIKEN
Tel
0172-33-5111
jm5911@hirosaki-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
| 2019 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_12492/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_12492/_pdf/-char/ja
Number of participants that the trial has enrolled
63
Results
Muscle strengthening and aerobic exercise do not appear to be effective treatments for patients with LSS.
Longitudinal results suggest that some outcomes are positive regardless of the type of exercise therapy.
Results date posted
| 2024 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with LSS were randomly allocated to a stretching group (n=32) and a combined group that performed muscle strengthening and aerobic exercise in addition to stretching (n=31).
Participant flow
The frequency of visits to the hospital was once per week, and self-exercise was performed at home. The intervention period was 2 months
Adverse events
None
Outcome measures
Outcomes included subjective evaluations of back pain, leg pain, and numbness and scores on the Oswestry Disability Index (ODI), a LSS symptom scale, and a quality of life scale (QOL).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043113
