UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Motohiro Inoue
Organization	Meiji University of Integrative Medicine
Division name	Faculty of Acupuncture and moxibustion
Address	Hiyoshi-cho, Nanatan-shi, Kyoto
TEL	++81-771-72-1181
Email	mo_inoue@meiji-u.ac.jp

Public contact
Name of contact person	Motohiro Inoue
Organization	Meiji University of Integrative Medicine
Division name	Faculty of Acupuncture and moxibustion
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 05 Day
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

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Publication of results	Unpublished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