UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042632
Receipt number R000048648
Scientific Title THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS
Date of disclosure of the study information 2020/12/03
Last modified on 2020/12/03 05:20:07

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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 or person

Institute

Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name