UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047195 |
|---|---|
| Receipt number | R000053827 |
| Scientific Title | Effects of acupuncture on neck/shoulder stiffness (chonic neck pain) : A randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2022/04/13 17:46:12 |
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Basic information
Public title
Is acupuncture really effective on neck/shoulder stiffness (chronic neck pain) ? A randomized double-blind placebo controlled clinical trial.
Acronym
IAREONSS (cnp) ARDBCT
Scientific Title
Effects of acupuncture on neck/shoulder stiffness (chonic neck pain) : A randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
EAK (cnp) ARDBCT
Region
| Japan |
Condition
Condition
Musculoskeletal discomfort
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of acupuncture on neck/shoulder stiffness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of neck/shoulder stiffness immediately and 24 hours after the treatment
Key secondary outcomes
Practitioners' and patients' guesses at the needle authenticity and their confidence on their guesses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Treatment with penetrating needles
Interventions/Control_2
Treatment with press-skin placebo needles (the needle tip presses against the skin)
Interventions/Control_3
Treatment with skin-touch placebo needles (the needle tip presses against the skin)
Interventions/Control_4
Treatment with no-touch placebo needles (the needle tip does not reach the skin)
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
Patients with neck/shoulder stiffness not from organic disease
Key exclusion criteria
1. Cervical spondylosis
2. Cervical disc herniation
3. Cervico-omo-brachial syndrome
4. Thoracic outlet syndrome
5. Liver, gallbladder or heart disease
6. High blood pressure
7. Cerebral vascular disease
8. Neurological disease
9. Under any pharmacological treatment
10. Patients who will receive any cure for neck/shoulder stiffness or acupuncture treatment within 24 hours after treatment in this study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Nobuari |
| Middle name | |
| Last name | Takakura |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo, Japan
TEL
03-6703-7000
takakura@tau.ac.jp
Public contact
Name of contact person
| 1st name | Nobuari |
| Middle name | |
| Last name | Takakura |
Organization
Tokyo Ariake University of Medical and Health Sciences
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
Ariake, Koto-ku, Tokyo, Japan
TEL
03-6703-7000
Homepage URL
takakura@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Health Sciences IRB
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan
Tel
03-6703-7000 (+81-3-6703-7000)
akiyama@tau.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
| 2022 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-16K09266/16K09266seika/
Number of participants that the trial has enrolled
160
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Pending approval from the journal to which you are submitting.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053827
