UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030688 |
|---|---|
| Receipt number | 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 11:15:31 |
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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
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
mo_inoue@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035039
