UMIN-CTR Clinical Trial

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
Email	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
Email	ryoiida03@gmail.com

Sponsor
Institute	Department of Anesthesiology, Nihon University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036996