UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041210 |
|---|---|
| Receipt number | R000047064 |
| Scientific Title | The immediate effect of a trigger point injection with local anesthetic affects the subsequent course of pain in myofascial pain syndrome in cancer patients |
| Date of disclosure of the study information | 2020/07/26 |
| Last modified on | 2020/07/26 21:24:25 |
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Basic information
Public title
The immediate effect of a trigger point injection with local anesthetic affects the subsequent course of pain
Acronym
The immediate effect of a trigger point injection
Scientific Title
The immediate effect of a trigger point injection with local anesthetic affects the subsequent course of pain in myofascial pain syndrome in cancer patients
Scientific Title:Acronym
The immediate effect of a trigger point injection
Region
| Japan |
Condition
Condition
Myofascial pain syndrome
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify how the effect of a decrease in pain immediately after TPI with local anesthetic affected the subsequent course of pain, and whether it increased expectations of a decrease in pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was a difference in the rate of patients with pain reduction at 7 days after TPI, between patients with and without a decrease in pain immediately after TPI.
Key secondary outcomes
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
Cancer patients who received TPI for MPS
Key exclusion criteria
(1) were younger than 20 years
(2) had any comorbidity relating to psychiatric diseases or conditions that made communication difficult, such as cognitive impairment
Target sample size
205
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505, Shinmachi, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505, Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
2-5-1-505, Shinmachi, Hirakata, Osaka
Tel
072-804-0101
hasuohid@hirakata.kmu.ac.jp
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
| 2020 | Year | 07 | Month | 26 | 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
205
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, single-center, observational clinical trial
Management information
Registered date
| 2020 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047064
