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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000018465
Receipt No. 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

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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
Email 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
Email kn-spd@med.email.ne.jp

Sponsor
Institute Kanazawa Neurosurgical Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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