UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035065 |
|---|---|
| Receipt number | R000039973 |
| Scientific Title | Effectiveness of intervention using nerve mobilization in acute phase for patients undergoing lumbar posterior decompression or fusion for spinal canal stenosis |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2019/06/02 05:35:11 |
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Basic information
Public title
Effectiveness of intervention using nerve mobilization in acute phase for patients undergoing lumbar posterior decompression or fusion for spinal canal stenosis
Acronym
Intervention using nerve mobilization in acute phase after lumbar surgery
Scientific Title
Effectiveness of intervention using nerve mobilization in acute phase for patients undergoing lumbar posterior decompression or fusion for spinal canal stenosis
Scientific Title:Acronym
Intervention using nerve mobilization in acute phase after lumbar surgery
Region
| Japan |
Condition
Condition
Lumbar spinal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of nerve mobilization in acute phase after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength, sensation, numbness, pain. 4th day and 11th day after surgery
Key secondary outcomes
Oswestry disability index 2.0,Tampa Scale for Kinesiophobia, Hospital Anxiety and Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
Nerve mobilization
Interventions/Control_2
Placebo
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent posterior lumbar depression or fusion surgery for diagnosis of lumbar spinal stenosis.
And, patients with remnant symptoms remaining after surgery
Key exclusion criteria
Intraoperative dural injury, Postoperative hematoma,Postoperative compression fracture,Serious complications such as infection, Patients who can not train on walking on the fourth day after surgery,Patients with cervical thoracic vertebrae at the surgical site, Surgical operation over 4 vertebras and History of patients with spinal surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Yogi |
Organization
University of Zaragoza
Division name
Master OMT
Zip code
50001
Address
Pedro Cerbuna 12 50009 Zaragoza - Spain
TEL
08067336898
k_yogi_kudan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Yogi |
Organization
Kudanzaka Hospital
Division name
Rehabilitation
Zip code
1020074
Address
1-6-12, Kudanminami, Chiyoda-Ku, Tokyo, Japan
TEL
0332629191
Homepage URL
k_yogi_kudan@yahoo.co.jp
Sponsor or person
Institute
Kudanzaka 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
Kudanzaka Hospital
Address
1-6-12, Kudanminami, Chiyoda-Ku, Tokyo
Tel
0332629191
k_yogi_kudan@yahoo.co.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
九段坂病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Nerve Mobilization Group 21
Placebo group 19
No significant difference between groups
Results date posted
| 2019 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
for presentation
Date of the first journal publication of results
Baseline Characteristics
Patients who have residual symptoms after lumbar surgery but have good progress
Participant flow
Adverse events
Outcome measures
Strength, numbness, pain, sense, ODI, Tampa Scale, HADS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039973
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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