UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017649 |
|---|---|
| Receipt number | R000020449 |
| Scientific Title | Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2017/01/13 22:15:42 |
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Basic information
Public title
Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial
Acronym
Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial
Scientific Title
Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial
Scientific Title:Acronym
Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial
Region
| Japan |
Condition
Condition
Neck pain
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate to the immediate effects of thoracic spine self-mobilization on neck pain in a randomized clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Neck Disability Index
Key secondary outcomes
Visual analogue scale
Active cervical range of motion
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions Group:Thoracic spine self-mobilization
Interventions/Control_2
Placebo Group: Hip flex active movement
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Mechanical neck pain
2.Neck Disability Index score of 15% or greater
Key exclusion criteria
1.History of a whiplash injury within 2 months
2.Severe thoracic kyphosis
3.Myelopathy
4.Severe cervical radiculopathy
5.Vertebral fracture
6.History of neck and thoracic surgery
7.Cancer
8.Infection
9.Rheumatism
10.Ankylosing spondylitis
11.cognitive disorder
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Nitta, Koji Nakamaru |
Organization
Graduate school of Human Health Sciences, Tokyo Metropolitan University
Division name
Division of Physical Therapy, Nitta laboratory
Zip code
Address
7-2-10 Higasiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
nittaosm@tmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Nitta, Koji Nakamaru |
Organization
Graduate school of Human Health Sciences, Tokyo Metropolitan University
Division name
Division of Physical Therapy, Nitta laboratory
Zip code
Address
7-2-10 Higasiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
nittaosm@tmu.ac.jp
Sponsor or person
Institute
Graduate school of Human Health Sciences, Tokyo Metropolitan University
Division of Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
None
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
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
寺嶋整形外科医院リハビリテーション科（東京）
Department of Rehabilitation Medicine, Terashima Orthopaedic Clinic(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
| 2015 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
