UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051477 |
|---|---|
| Receipt number | R000058724 |
| Scientific Title | The clinical effectiveness of moxibustion therapy (Fireless Moxibustion Patch) on university students with chronic neck and shoulder or low back pain that cause poor learning performance.: a preliminary randomized clinical |
| Date of disclosure of the study information | 2023/06/29 |
| Last modified on | 2024/10/09 15:53:43 |
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Basic information
Public title
The clinical effectiveness of moxibustion on university students with chronic neck and shoulder or low back pain that cause poor learning performance.
Acronym
Effect of moxibustion on university students with chronic neck and shoulder or low back pain that cause poor learning performance.
Scientific Title
The clinical effectiveness of moxibustion therapy (Fireless Moxibustion Patch) on university students with chronic neck and shoulder or low back pain that cause poor learning performance.: a preliminary randomized clinical
Scientific Title:Acronym
Effect of moxibustion therapy (Fireless Moxibustion Patch) on university students with chronic neck and shoulder or low back pain that cause poor learning performance.
Region
| Japan |
Condition
Condition
Chronic neck and shoulder or low back pain causing poor learning performance
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether moxibustion stimulant is a useful countermeasure for the treatment of chronic neck and shoulder or low back pain with poor learning performance in university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale (NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
moxibustion therapy for chronic neck and shoulder pain(katakori)
Interventions/Control_2
no treatment for chronic neck and shoulder pain(katakori)
Interventions/Control_3
moxibustion therapy for chronic low back pain
Interventions/Control_4
no treatment for chronic low back pain
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic neck and shoulder pain(katakori)
1. university student
2. Those who have neck and shoulder pain (katakori) for more than 3 months (NRS4-10).
3. Those who consider themselves, learning performance is impaired because of 2.
4. No abnormalities on neurological examination (tendon reflex, muscle and sensory).
chronic low back pain
1. university student
2. Those who have low back pain for more than 3 months (NRS4-10).
3. Those who consider themselves, learning performance is impaired because of 2.
4. No abnormalities on neurological examination (tendon reflex, muscle and sensory).
Key exclusion criteria
chronic neck and shoulder pain(katakori), chronic low back pain
1. Those who are participating (or plan to participate) in other studies or trials at the same time
2. Those who are participating (or plan to participate) in moxibustion therapy at the same time
3. Those who were deemed inappropriate for this study by the investigator
For subjects who have both neck and shoulder pain(katakori) and low back pain, priority shall be given to those symptoms that have a strong impact on learning performance.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Minakawa |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
y.minakawa@thu.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Minakawa |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
Homepage URL
y.minakawa@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
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
Teikyo Heisei University
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
Tel
0358433111
rec@thu.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
| 2023 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058724
