UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Non-traumatic mechanical neck pain

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Takasaki

Organization

Saitama Prefectural University

Division name

Physical Therapy

Zip code

Address

Sannomiya 820, Koshigaya, Saitama

TEL

0489734706

Email

takasaki-hiroshi@spu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Takasaki

Organization

Saitama Prefectural University

Division name

Physical Therapy

Zip code

Address

Sannomiya 820, Koshigaya, Saitama

TEL

0489734706

Homepage URL

Email

takasaki-hiroshi@spu.ac.jp

Institute

Saitama Prefectural University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2015

Year

10

Month

21

Day

Date of IRB

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

Other related information

Registered date

2015

Year

04

Month

29

Day

Last modified on

2017

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020102