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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035065
Receipt No. R000039973
Official scientific title of the study 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 2018/12/06

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Basic information
Official scientific title of the study Effectiveness of intervention using nerve mobilization in acute phase for patients undergoing lumbar posterior decompression or fusion for spinal canal stenosis
Title of the study (Brief title) 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 Kohei Yogi
Organization University of Zaragoza
Division name Master OMT
Address Pedro Cerbuna 12 50009 Zaragoza - Spain
TEL 08067336898
Email k_yogi_kudan@yahoo.co.jp

Public contact
Name of contact person Kohei Yogi
Organization Kudanzaka Hospital
Division name Rehabilitation
Address 1-6-12, Kudanminami, Chiyoda-Ku, Tokyo, Japan
TEL 0332629191
Homepage URL
Email k_yogi_kudan@yahoo.co.jp

Sponsor
Institute Kudanzaka Hospital
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 11 Month 28 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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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