UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018465 |
|---|---|
| Receipt number | R000021383 |
| Scientific Title | Clinical Application of the Hanger Reflex to the Treatment of Chronic Headache, Neck Pain and Shoulder Pain |
| Date of disclosure of the study information | 2015/07/29 |
| Last modified on | 2017/07/30 22:45:02 |
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Basic information
Public title
Clinical Application of the Hanger Reflex to the Treatment of Chronic Headache, Neck Pain and Shoulder Pain
Acronym
Treatment of Headache and neck/shoulder pain by Hanger reflex
Scientific Title
Clinical Application of the Hanger Reflex to the Treatment of Chronic Headache, Neck Pain and Shoulder Pain
Scientific Title:Acronym
Treatment of Headache and neck/shoulder pain by Hanger reflex
Region
| Japan |
Condition
Condition
Chronic headache, neck pain, shoulder pain
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate of improvement of chronic headache, neck pain and shoulder pain using portable devices utilizing the hanger reflex by a multicenter clinical trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate before and 3 months after trial
Toronto Western Spasmodic Torticollis Rating Scale
HIT-6
Visual Analogue Scale (Pain)
Key secondary outcomes
Evaluate before and 3 months after trial
PHQ-9
Velocity of head movement and head range of movement
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
| Device,equipment |
Interventions/Control_1
Apply for portable devices induce the hanger reflex 30 min./day for 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Suffering from headache, neck pain and shoulder pain for more than 3 months
(2)Having restrection of head movement.
(3)Patients can visit hospital.
Key exclusion criteria
(1)Patients who don't have hanger reflex
(2)Patients having a unstable disease, and possibility to change medicines during study
(3)Patient ruled unfit by a doctor responsible for the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Asahi |
Organization
Kanazawa Neurosurgical Hospital
Division name
Department of Neurosurgery
Zip code
Address
262-2 Goumachi, Nonoichi city, Kanazawa city, Ishikawa
TEL
076-246-5600
takashi-tym@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Mukai |
Organization
administrative department
Division name
administration section
Zip code
Address
262-2 Goumachi, Nonoichi city, Kanazawa city, Ishikawa
TEL
076-246-5600
Homepage URL
kn-spd@med.email.ne.jp
Sponsor or person
Institute
Kanazawa Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Electro-Communications
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
金沢脳神経外科病院（石川県）、済生会松山病院（愛媛県）、富永病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 29 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2017 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021383
