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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030688
Receipt No. R000035039
Scientific Title Randomized controlled study to determine the combined effect of acupuncture treatment and modern medical treatment for lumbar and lower limb symptoms in spinal canal stenosis patients
Date of disclosure of the study information 2018/01/05
Last modified on 2018/01/05

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Basic information
Public title Randomized controlled study to determine the combined effect of acupuncture treatment and modern medical treatment for lumbar and lower limb symptoms in spinal canal stenosis patients
Acronym Effect of combined therapy by acupuncture treatment and modern medical treatment
Scientific Title Randomized controlled study to determine the combined effect of acupuncture treatment and modern medical treatment for lumbar and lower limb symptoms in spinal canal stenosis patients
Scientific Title:Acronym Effect of combined therapy by acupuncture treatment and modern medical treatment
Region
Japan

Condition
Condition lumbar spinal stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A comparative study applying modern medical treatment only, modern medical treatment plus real acupuncture treatment, and modern medical treatment plus sham acupuncture treatment to clarify the combined effect of modern medical treatment and acupuncture treatment for lumbar spinal stenosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue scale
each time of treatment and 4, 12, 24 weeks after the completion of the treatments
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver Other
Interventions/Control_1 Acupuncture treatment
once a week for four weeks, four times
Interventions/Control_2 Modern medical treatment (drugs, physical therapy and orthotic therapy, performing physical therapy)
once a week for four weeks, four times
Interventions/Control_3 Sham acupuncture treatment
once a week for four weeks, four times
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 Patients with lumbar and lower limb symptoms due to spinal canal stenosis for 3 months or more.
Key exclusion criteria Patients requiring urgent surgical treatment.
Patients with serious internal disease.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Inoue
Organization Meiji University of Integrative Medicine
Division name Faculty of Acupuncture and moxibustion
Zip code
Address Hiyoshi-cho, Nanatan-shi, Kyoto
TEL ++81-771-72-1181
Email mo_inoue@meiji-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Inoue
Organization Meiji University of Integrative Medicine
Division name Faculty of Acupuncture and moxibustion
Zip code
Address Hiyoshi-cho, Nanatan-shi, Kyoto
TEL ++81-771-72-1181
Homepage URL
Email mo_inoue@meiji-u.ac.jp

Sponsor
Institute Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization Meiji University of Integrative Medicine
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
Address
Tel
Email

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
2018 Year 01 Month 05 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
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035039

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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