UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032449 |
|---|---|
| Receipt number | R000036996 |
| Scientific Title | Salivary alpha-amylase activity correlates with pain relief scale after low level laser irradiation in patients with neuropathic pain?: A pilot study |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/04/19 19:41:59 |
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Basic information
Public title
Salivary alpha-amylase activity correlates with pain relief scale after low level laser irradiation in patients with neuropathic pain?: A pilot study
Acronym
Salivary alpha-amylase activity correlates with pain relief scale after low level laser irradiation in patients with neuropathic pain?: A pilot study
Scientific Title
Salivary alpha-amylase activity correlates with pain relief scale after low level laser irradiation in patients with neuropathic pain?: A pilot study
Scientific Title:Acronym
Salivary alpha-amylase activity correlates with pain relief scale after low level laser irradiation in patients with neuropathic pain?: A pilot study
Region
| Japan |
Condition
Condition
neuropathic pain
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether salivary alpha-amylase activity reflects analgesia after low level laser irradiation in patients with neuropathic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value of salivary alpha-amylase
Key secondary outcomes
Pain relief scale
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
The values of alpha-amylase are measured before and after low level laser irradiation in patients with neuropathic pain.
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
Outpatients with neuropathic pain undergoing low level laser therapy with linearly polarized near-infrared equipment for pain relief.
Key exclusion criteria
1. Patients who is not able to keep still and calm during the study
2. Patients with psychological diseases
3. Pregnant patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Iida |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
101-0062
Address
1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
81-3-3293-1711
ryoiida03@gmail.com
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Iida |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
101-0062
Address
1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
81-3-3293-1711
Homepage URL
ryoiida03@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nihon University School of Medicine
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
Nihon University School of Medicine
Address
1-6, Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
Tel
81-3-3293-1711
ryoiida03@gmail.com
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 | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036996
