UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042574 |
|---|---|
| Receipt number | R000048593 |
| Scientific Title | Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain. |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2022/05/30 09:10:00 |
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Basic information
Public title
Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Acronym
Immediate Effect of acupuncture on sensitized tissue.
Scientific Title
Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Scientific Title:Acronym
Immediate Effect of acupuncture on sensitized tissue.
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the immediate effect of acupuncture on sensitized tissues in patients with low back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pressure pain threshold
Key secondary outcomes
Pressure pain rating
Temporal summation
Visual Analog Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Deep acupuncture
Interventions/Control_2
Shallow acupuncture
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) chronic low back pain lasting 3 month or more
2) Patients with localized pressure pain on lumbar part
Key exclusion criteria
1) Patients with lower numbness pain, numbness, weakness
2) Patients who had operation for lumbar spine in the past.
3) Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Kitagawa |
Organization
Kansai University of Health Sciences
Division name
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL
072-453-8251
kitagawa@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Yoji |
| Middle name | |
| Last name | Kitagawa |
Organization
Kansai University of Health Sciences
Division name
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL
072-453-8251
Homepage URL
kitagawa@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
Tel
072-453-8251
k.kimura@kansai.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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
