UMIN-CTR Clinical Trial

Basic information
Public title	EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROMAGNETIC THERAPY ON TRIGEMINAL NEURALGIA
Acronym	EFFECT OF LLLT VERSUS EMT ON TRIGEMINAL NEURALGIA
Scientific Title	EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROMAGNETIC THERAPY ON TRIGEMINAL NEURALGIA
Scientific Title:Acronym	EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROMAGNETIC THERAPY ON TRIGEMINAL NEURALGIA
Region	Africa

Condition
Condition	trigeminal neuralgia patients
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of Low level laser therapy versus electromagnetic therapy on trigeminal neuralgia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	LLLT is more effective than electromagnetic therapy at reducing trigeminal pain and increasing masseter and temporalis muscle compound action potential amplitude in trigeminal neuralgia patients
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	LOW LEVEL LASER low power 15 m W helium-neon laser wave length: 830 A units 20 min/session fifteen Sessions day after day
Interventions/Control_2	electromagnetic therapy 20 min/ session fifteen Sessions day after day (3 days/ week). Continuous magnetic field Magnetic induction for 30 Gauss and frequency was 50 Hz.
Interventions/Control_3	medication
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	25 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	All participants' age ranged from 25 to 40 years, both sex (male and female), Patients with chronic trigeminal neuralgia, (from three to six months), Neuritis patients, Idiopathic cause or Undetectable cause of trigeminal neuralgia. Patients were conscious, co-operative and free from psychological disorders (as documented by a psychologist), and disabilities secondary to orthopedic problems or special senses impairments..
Key exclusion criteria	Patients were excluded if they had TN secondary to tumor, herpes zoster or any other causes, i.e. serious cardiopulmonary dysfunction, past invasive treatment (radiofrequency, ethanol, glycerinum injection, Gama-knife microvascular decompression) or coagulation dysfunction. The patients were excluded if they have a previous disability in the upper extremity, any musculoskeletal disorder including contracture deformity or limitation of joint motion prior to illness, visual and auditory problems.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name ISLAM Middle name MAHMOUD Last name ALAZAB
Organization	FACULTY OF PHYSICAL THERAPY - CAIRO UNIVERSITY
Division name	Physical Therapy for Neuromuscular disorders and its Surgery
Zip code	00202
Address	7 Ahmed Alzayyat St. Ben Alsarayat - Giza
TEL	00201002403314
Email	islam_alazab2005@yahoo.com

Public contact
Name of contact person	1st name ISLAM Middle name MAHMOUD Last name ALAZAB
Organization	FACULTY OF PHYSICAL THERAPY -CAIRO UNIVERSITY
Division name	Physical Therapy for Neuromuscular disorders and its Surgery
Zip code	00202
Address	7 Ahmed Alzayyat St. Ben Alsarayat - Giza
TEL	00201002403314
Homepage URL
Email	islam_alazab2005@yahoo.com

Sponsor
Institute	CAIRO UNIVERSITY FACULTY OF PHYSICAL THERAPY Department of Physical Therapy for Neuromuscular disorders and its Surgery
Institute
Department

Funding Source
Organization	self
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	FACULTY OF PHYSICAL THERAPY - Cairo University
Address	7 Ahmed Alzayyat St. Ben Alsarayat - Giza
Tel	00201002403314
Email	islam_alazab2005@yahoo.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	2021 Year 01 Month 29 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	45
Results	There were significant improvements after treatment in all groups, with a significant difference between the Electromagnetic and Laser groups, in favor of the Laser group.
Results date posted	2021 Year 01 Month 19 Day
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	Enrolling by invitation
Date of protocol fixation	2020 Year 01 Month 01 Day
Date of IRB	2019 Year 12 Month 22 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 09 Month 01 Day
Date of closure to data entry	2020 Year 10 Month 01 Day
Date trial data considered complete	2020 Year 11 Month 01 Day
Date analysis concluded	2020 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 19 Day
Last modified on	2021 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049156