UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002731 |
|---|---|
| Receipt number | R000003323 |
| Scientific Title | Efficacy of cervical muscle relaxation for patient with depression, anxiety, and autonomic imbalances - proposal for new disease entity "cervical neuromuscular syndrome"- a pilot study |
| Date of disclosure of the study information | 2009/11/09 |
| Last modified on | 2012/11/12 14:16:30 |
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Basic information
Public title
Efficacy of cervical muscle relaxation for patient with depression, anxiety, and autonomic imbalances - proposal for new disease entity "cervical neuromuscular syndrome"- a pilot study
Acronym
Efficacy of cervical muscle relaxation for patient with depression, anxiety, and autonomic imbalances - proposal for new disease entity "cervical neuromuscular syndrome"- a pilot study
Scientific Title
Efficacy of cervical muscle relaxation for patient with depression, anxiety, and autonomic imbalances - proposal for new disease entity "cervical neuromuscular syndrome"- a pilot study
Scientific Title:Acronym
Efficacy of cervical muscle relaxation for patient with depression, anxiety, and autonomic imbalances - proposal for new disease entity "cervical neuromuscular syndrome"- a pilot study
Region
| Japan |
Condition
Condition
Depression, anxiety, autonomic imbalances
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with psychiatric symptoms such as depression and anxiety, and autonomic imbalance-associated non-specific complaints accompanying cervical muscular tension and neck pain often consult psychiatric clinics. Their conditions are commonly resistant to pharmacological treatment such as antidepressants, however, their cervical tension is generally ignored, and so we tried to treat these conditions reducing by their cervical muscular tension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the usefulness by the Matsui index containing a physical petition classified into 30 items.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Relaxation of the symptoms before and behind treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient of depression, the anxiety, and autonomic imbalance who consulted by general physical complaint.
Key exclusion criteria
Those who will be in the status that treatment can be undergone, and those who refused treatment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Fujimoto |
Organization
Yokakai Association
Division name
Fujimoto hospital
Zip code
Address
17-4, Hayasuzu-cho, Miyakonojo-city, Miyazaki, Janan, 885-0055
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Fujimoto |
Organization
Yokakai Association
Division name
Fujimoto hospital
Zip code
Address
TEL
0986-25-1313
Homepage URL
Sponsor or person
Institute
Yokakai Association
Institute
Department
Personal name
Funding Source
Organization
Yokakai Association
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 11 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2003 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 09 | Day |
Last modified on
| 2012 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003323
