UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031338 |
|---|---|
| Receipt number | R000035745 |
| Scientific Title | The Frequency of Myofascial Pain Sydrome In Incurable Cancer Patients Receiving Palliative Care.A Multi-Center, Observational Study. |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2018/02/16 18:38:59 |
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Basic information
Public title
The Frequency of Myofascial Pain Sydrome In Incurable Cancer Patients Receiving Palliative Care.A Multi-Center, Observational Study.
Acronym
MyCar study
Scientific Title
The Frequency of Myofascial Pain Sydrome In Incurable Cancer Patients Receiving Palliative Care.A Multi-Center, Observational Study.
Scientific Title:Acronym
MyCar study
Region
| Japan |
Condition
Condition
Incurable cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and risk factors of myofascial pain syndrome (MPS) in cancer patients during palliative care intervention.
Basic objectives2
Others
Basic objectives -Others
MPS frequency (according to Simons' diagnostic criteria)
Presence / absence of device
Correlation between device position and MPS position
Correlation between surgical history and MPS frequency
Correlation between PS (performance status) and MPS frequency
The response rate of Trigger point block injection (TPI)
Presence or absence of MPS and the relationship between alexithymia, depression and anxiety
Frequency of extensive chronic pain in cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of MPS (Diagnostic criteria of Rivers)
Key secondary outcomes
MPS frequency (according to Simons' diagnostic criteria)
Presence / absence of device
Correlation between device position and MPS position
Correlation between surgical history and MPS frequency
Correlation between PS (performance status) and MPS frequency
The response rate of Trigger point block injection (TPI)
Presence or absence of MPS and the relationship between alexithymia, depression and anxiety
Frequency of extensive chronic pain in cancer patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Inpatients planned for intervention by palliative care teams or patients expected to be admitted to palliative care units
2) Cancer is announced
3) Patients with non-curable solid cancers
4) Age at registration is over 20 years old
5) Average NRS of pain 24 hours before registration is greater than 4 or 4
6) Blood and biochemical test data within 2 weeks of registration are available
Key exclusion criteria
1) consciousness disorder, pain assessment is impossible
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Ishiki |
Organization
National Cancer Center Hospial
Division name
Department of Palliative Medicine
Zip code
Address
5-1-1 Tsukiji , Chuo-Ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
ishiki-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junya Kinkawa |
Organization
IMSUT Hospital
Division name
Joint Surgery
Zip code
Address
4-6-1, Shirokanedai, Minato-Ku,Tokyo 108-8639, Japan
TEL
03-3443-8111
Homepage URL
kinspoint@gmail.com
Sponsor or person
Institute
National Cancer Center Hospial
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2018 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
Estimate accurate 95% confidence intervals based on the proportion of MPS in all cases and binomial distribution.
Management information
Registered date
| 2018 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035745
