UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigating the effect of the McKenzie method on motor control of deep cervical flexors and cervical joint position sense for individuals with non-traumatic neck pain
Title of the study (Brief title)	Multicenter prospective cohort study about the influence of Mechanical Diagnosis and Therapy (MDT) on motor control of deep cervical flexors and cervical joint position sense for individuals with non-traumatic neck pain
Region	Japan

Condition
Condition	Non-traumatic mechanical neck pain
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study will be to investigate if MDT improves motor control of the deep cervical flexors or cervical joint position sense.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor control of the deep cervical flexors will be assessed using the Cranio-cervical flexion test. Cervical joint position sense will be assessed using the cervical joint re-positioning test. These assessments will be done at the initial intervention and 1 month after the initial intervention.
Key secondary outcomes	Self-reporting improvement will be assessed using a 7-point scale. Pain intensity will be assessed using the P4. The magnitude of disability will be assessed using the Neck Disability Index and Patient-specific functional scale. Impacts on activity of daily living will be assessed using the EQ-5D-5L. These assessments will be done at the initial intervention and 1 month after the initial intervention.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Each patient will be treated with routine MDT's assessments and treatments. The MDT assessments includes main outcome measures described above as well as manual muscle testing, neurological examinations and repeated movement testing. Intervention will be undertaken at most twice a week. An intervention period will not be specified. Data at 1 month after the initial assessment will be used in this study.
Interventions/Control_2
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	Those who will be treated by credential MDT therapists who are involved in this study Mechanical neck pain
Key exclusion criteria	Those with traumatic neck pain Those with contraindications to manual therapy techniques such as trauma, infection or severe osteoporosis Those with a history of neck surgery Those who cannot communicate well for some reasons
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Email	takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person	Hiroshi Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Homepage URL
Email	takasaki-hiroshi@spu.ac.jp

Sponsor
Institute	Saitama Prefectural University
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 21 Day
Anticipated trial start date	2015 Year 11 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 04 Month 29 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020102