determine the long term effects of LLLT and wrist splint and only splint with false laser on the outcome of mild to moderate carpal tunel syndrom (CTS).
Design
This randomized, double-blind, controlled trial was conducted on 64 hands with mild and moderate CTS from both genders that were randomly assigned to 32 populated groups.
Settings and conduct
This randomized, double-blind, controlled trial was conducted during 2014 in outpatient clinics of Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pain and numbness in the median nerve area ; positive clinical CTS tests ;The mild or moderate disease (carpal tunnel syndrome).
Exclusion criteria: the patients with severe CTS ;those receiving analgesic or anti-inflammatory drugs; history of steroid injection for CTS; history of diabetes or peripheral neuropathy
Intervention groups
Intervention group: Low level laser therapy (LLLT) is performed for 10 sessions (three times a week) using a calibrated laser device. Each treatment session lasts 20 minutes, which takes place in a rectangular area at 10 points in the volar wrist zone within the carpal tunnel area. In the control group sham laser therapy is used at the same intervals.
Main outcome variables
Pain, Nerve conduction, Peak sensory latency, Distal motor latency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120716010297N5
Registration date:2018-06-20, 1397/03/30
Registration timing:prospective
Last update:2018-06-20, 1397/03/30
Update count:0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Leili Allahbakhshian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7079
Email address
allahbakhshian@med.mui.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2635-08-27, 2014/06/05
Expected recruitment end date
2636-08-27, 2015/06/05
Actual recruitment start date
2635-08-27, 2014/06/05
Actual recruitment end date
2636-08-27, 2015/06/05
Trial completion date
empty
Scientific title
The long-term Effect of low level laser therapy on clinical symptoms and electrophysiologic parameters in patients with carpal tunnel syndrome
Public title
The long-term Effect of low level laser therapy on carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain and numbness in the median nerve territory
Positive Phalen’s and Tinel test
Mild or moderate involvement of median nerve at the wrist according to electrophysiological findings.
Exclusion criteria:
Severe CTS based on electrodiagnostic criteria
Receiving continuous analgesic or anti-inflammatory drugs
Patients with history of steroid injections into the carpal tunnel
History of thyroid disease, diabetes or peripheral neuropathy
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
All the patients were randomly assigned to two intervention groups using a computer-based random digit generator based on the consecutive admission numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the clinical examinations and the electrophysiological studies were performed by a physician who was blinded toward the study groups. the patients were also blinded toward their study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Intervention group:Patients in this group received LLLT through 10 20-minute sessions three times a week. LLLT was done using calibrated laser device model 620 with continuous wave of 880 nm and a pulse wave of 905 nm with a maximum power of 1100 mV and frequency of 1000 Hz.
Category
Rehabilitation
2
Description
Control group: Patients in this group received sham laser therapy through the same instruction with the sham laser therapy. In addition, they received vitamin B1 at a dose of 300 mg per day and static night splinting for wrist for two months.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Shila Haghighat
Street address
Ayatollah Kashani Hospital, Kashani St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
sh-haghighat@med.mui.ac.ir
Web page address
http://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
Hezar Jarib St. Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://www.research.mui.ac.ir
Grant name
nil
Grant code / Reference number
31832
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohre Zabihi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jarib St. Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31322222
Email
z.zabihi79@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Saeed Khosrawi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jarib Av. Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174235618
Phone
+98 31222222
Email
khosrawi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohre Zabihi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jarib St. Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31322222
Email
z.zabihi79@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We have plan to publish the manuscript
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document