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 2022/03/03 12:55:07

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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

LSS specific symptom scale and QOL scale
Baseline,1 month,2month

Key secondary outcomes

NRS
Oswestry Disability Index Score
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

Email

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


Email

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

Email

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


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

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

2022 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name