UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016049 |
|---|---|
| Receipt number | R000018641 |
| Scientific Title | Local Corticosteroid Injection to Trigger Points in the Short-Term Treatment of Cervicogenic Headache: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2014/12/24 16:48:00 |
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Basic information
Public title
Local Corticosteroid Injection to Trigger Points in the Short-Term Treatment of Cervicogenic Headache: A Randomized Clinical Trial
Acronym
Local corticosteroid injection for cervicogenic headache
Scientific Title
Local Corticosteroid Injection to Trigger Points in the Short-Term Treatment of Cervicogenic Headache: A Randomized Clinical Trial
Scientific Title:Acronym
Local corticosteroid injection for cervicogenic headache
Region
| Asia(except Japan) |
Condition
Condition
Cervicogenic Headache
Classification by specialty
| Medicine in general | Neurology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the clinical efficacy of corticosteroid injection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
for the short-term local corticosteroid injection to trigger points is an effective treatment of cervicogenic headache
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
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
| Medicine |
Interventions/Control_1
Patients were given a single dose of 20 mg long acting betamethasone (0.5 ml). The mixture was injected at trigger points in paraspinal muscles. All the patients were asked to return gradually to normal activities but to avoid pain-provoking physical stresses, especially within the first 48 hrs after injection. Participants were also instructed not to use brace, physiotherapy, and analgesic medications including NSAIDs.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
unilateral, intermittent, and localized pain with moderate to severe intensity on the occipital, frontal, temporal or orbital regions, and lasting hours to days
Key exclusion criteria
recent trauma to the head and neck regions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kamran Azma |
Organization
Islamic Republic of Iran Army University of Medical Sciences
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
School of Medicine, Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh St, Western fatemi, Tehran, Islamic Republic of Iran
TEL
+81-0982122728029
kamazema@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kamran Azma |
Organization
Islamic Republic of Iran Army University of Medical Sciences
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
School of Medicine, Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh St, W
TEL
+81-0982122728029
Homepage URL
kamazema@yahoo.com
Sponsor or person
Institute
Islamic Republic of Iran Army University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
authors
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
| 2014 | Year | 12 | Month | 24 | 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
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018641
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