UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044078 |
|---|---|
| Receipt number | R000050294 |
| Scientific Title | Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial |
| Date of disclosure of the study information | 2021/04/30 |
| Last modified on | 2021/04/30 03:58:43 |
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Basic information
Public title
Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Acronym
Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Scientific Title
Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Scientific Title:Acronym
Effectiveness of press needles for self-care in chronic neck pain: a randomized, placebo-controlled trial
Region
| Japan |
Condition
Condition
chronic neck pain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of self-care for chronic neck pain with applying press needles once a week for three weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neck pain intensity using a 100 mm visual analogue scale (VAS) is assessed at baseline (A0), one week after the first intervention (A1), after finishing intervention (A2), and one week follow up (A3).
Key secondary outcomes
Motion-related neck pain (VAS) / Pressure pain threshold (PPT) / The Japanese version of the neck disability index (J-NDI) are assessed at baseline (A0), one week after the first intervention (A1), after finishing intervention (A2), and one week follow up (A3).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. press needles
Sessions are conducted once a week for three weeks. The intervention is applying press needles (0.15*0.6 mm needle bonded to a medical tape) on tender points for 7 days.
Interventions/Control_2
2. placebo
Sessions are conducted once a week for three weeks. The intervention is applying placebo press needles (identical to the press needle, except the needle element had been removed) on tender points for 7 days.
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
presented with neck pain, stiffness or tenderness at least 3 months
Key exclusion criteria
neuropathic or traumatic neck pain / under analgesic, muscle relaxant or antidepressant medication 1 week before the study commence / having acupuncture treatment, massage or physiotherapy within 2 weeks prior to this study
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kawano |
Organization
University of Tsukuba
Division name
Faculty of Human Sciences
Zip code
305-8577
Address
1-1-1 Tenno-dai, Tukuba, Ibaraki
TEL
029-853-8504
kyoshiyuki@human.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Horike |
Organization
University of Tsukuba
Division name
master's program in rehabilitation science, graduate school of comprehensive human sciences
Zip code
112-0012
Address
3-29-1 Otsuka Bunkyo Tokyo
TEL
03-3942-6860
Homepage URL
s2040269@s.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
master's program in rehabilitation science, graduate school of comprehensive human sciences
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba
Address
3-29-1 Otsuka Bunkyo Tokyo
Tel
03-3942-6860
s2040269@s.tsukuba.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
| 2021 | Year | 04 | Month | 30 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2021 | Year | 04 | Month | 30 | Day |
Last modified on
| 2021 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050294
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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