UMIN-CTR 臨床試験登録情報の閲覧

Basic information
Public title	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS
Acronym	laser effectiveness in rheumatoid arthritis
Scientific Title	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS
Scientific Title:Acronym	laser effectiveness in rheumatoid arthritis
Region	Asia(except Japan)

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Medicine in general Clinical immunology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness and safety of low level laser therapy in the management of early onset rheumatoid arthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	There were significant decrease of morning stiffness (p=0.05), number of tender joints [TJN] (p=0.03), number of swelling joints [SJN] (p=0.04) and visual analogue scale [VAS] (p=0.01).
Key secondary outcomes	No changes in CRP, rheumatoid factor were found. There were no reported side effects of low level laser therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1. HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2. GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients
Interventions/Control_2	placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients
Interventions/Control_3	naproxen Naproxen is given as tablet 500mg twice per day. 10 patients
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	The diagnosis was identified according to 1987 revised criteria for RA classification (traditional format) ACR (1987) (9): 1) morning stiffness; 2) arthritis of three or more joint area; 3) arthritis of hand joints; 4) symmetrical arthritis; 5) rheumatoid nodules; 6) serum rheumatoid factor; 7) radiographic changes. A patient shall be said to have RA if he/she has satisfied at least four of these seven criteria. Criteria 1 through 4 must have been present for at least 6 weeks.
Key exclusion criteria	Patient with 2 clinical diagnoses are excluded.
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Muhamed Middle name Jumaa Last name Ahmail
Organization	Al-Kindy Teaching Hospital
Division name	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
Zip code	0000
Address	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
TEL	00964-07711827558
Email	sci.get5@gmail.com

Public contact
Name of contact person	1st name Muhamed Middle name Jumaa Last name Ahmail
Organization	Al-Kindy Teaching Hospital
Division name	Rheumatology clinic
Zip code	0000
Address	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
TEL	00964-07711827558
Homepage URL
Email	sci.get5@gmail.com

Sponsor
Institute	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
Institute
Department

Funding Source
Organization	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Iraqi

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Rheumatology clinic at Al-Kindy Teaching Hospital
Address	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq
Tel	00964-7711827558
Email	sci.get5@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	2020 Year 12 Month 03 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	34
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 01 Day
Date of IRB	2018 Year 12 Month 01 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 03 Day
Last modified on	2020 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048648