UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017324 |
|---|---|
| Receipt number | R000020102 |
| 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 |
| Date of disclosure of the study information | 2015/05/10 |
| Last modified on | 2017/06/19 21:02:46 |
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Basic information
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
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
| 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
takasaki-hiroshi@spu.ac.jp
Public contact
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
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 10 | 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020102
