UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043057 |
|---|---|
| Receipt number | R000049156 |
| Scientific Title | EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROMAGNETIC THERAPY ON TRIGEMINAL NEURALGIA |
| Date of disclosure of the study information | 2021/01/29 |
| Last modified on | 2021/01/19 20:15:00 |
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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
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
islam_alazab2005@yahoo.com
Sponsor or person
Institute
CAIRO UNIVERSITY
FACULTY OF PHYSICAL THERAPY
Department of Physical Therapy for Neuromuscular disorders and its Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049156
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