UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Immediate effects of thoracic spine self-mobilization in patients with neck pain: a randomized clinical trial
Title of the study (Brief title)	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	Osamu Nitta, Koji Nakamaru
Organization	Graduate school of Human Health Sciences, Tokyo Metropolitan University
Division name	Division of Physical Therapy, Nitta laboratory
Address	7-2-10 Higasiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Email	nittaosm@tmu.ac.jp

Public contact
Name of contact person	Osamu Nitta, Koji Nakamaru
Organization	Graduate school of Human Health Sciences, Tokyo Metropolitan University
Division name	Division of Physical Therapy, Nitta laboratory
Address	7-2-10 Higasiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Homepage URL
Email	nittaosm@tmu.ac.jp

Sponsor
Institute	Graduate school of Human Health Sciences, Tokyo Metropolitan University Division of Physical Therapy
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020449