Determination of effect of the low-power laser combined with ultrasound in the treatment of carpal tunnel syndrome
Design
Randomized controlled, single-blinded, and parallel-group design study
Settings and conduct
Patients with CTS will randomize into three groups (laser, ultrasound and laser with ultrasound). All patients will receive a wrist orthosis. one group undergo lasre therapy (with wavelength of 830 nm and at a dose of 9 J/cm2 on two points of 2 cm2) , the second group undergo ultrasound therapy (15 minutes per session to the area over the carpal tunnel at a frequency of 1 MHz and an intensity of 1.0 W/cm2, with pulsed mode duty cycle of 1:4 )and the third group undergo laser with ultrasound therapy.
Participants/Inclusion and exclusion criteria
Patients with carpal tunnel syndrome
Phalen test positive
Tonel test positive
Prolonged nerve conduction velocity
Intervention groups
Laser therapy, low-power diode laser, with wavelength of 830 nm and at a dose of 9 J/cm2 on two points of 2 cm2 over the transverse ligament for two weeks as 5 sessions per week.
Ultrasound treatment, 15 minutes per session to the area over the carpal tunnel at a frequency of 1 MHz and an intensity of 1.0 W/cm2, with pulsed mode duty cycle of 1:4 and a transducer area of 5 cm2 for two weeks as 5 sessions per week.
Laser with ultrasound therapy, Laser (similar to the Lasre group) follow
by ultrasound (similar to the ulrtasound group) for for two weeks as 5 sessions per week.
Main outcome variables
Visual Analog Scale, distal sensory and motor latencies of the
median nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042581N1
Registration date:2019-02-14, 1397/11/25
Registration timing:prospective
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Mohammad Reza Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3423 0949
Email address
m.asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the low-power laser combined with ultrasound in the treatment of carpal tunnel syndrome
Public title
The effect of the low-power laser combined with ultrasound in the treatment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with mild to moderate carpal tunnel syndrome
The grades of the CTS were scrutinized using electrodiagnostic findings as the grades 0-3 were mild to moderate and grades 4-6 were identified as severe
Phalen and Tinel test positive
Eligible participants were randomly randomly divided, using the table of random numbers,into three groups of trials including: Groups of US, Laser and laser with US. Concealment of allocation was performed using sequentially numbered, sealed, opaque, stapled envelopes. The randomization was per-formed by primary investigator.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients were blinded to the treatment allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.UMSHA.REC.1397.790
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrom
ICD-10 code
S64.1
ICD-10 code description
Injury of median nerve at wrist and hand level
Primary outcomes
1
Description
pain severity
Timepoint
First session (before intervention), 10 and 21 day (after intervention)
Method of measurement
Visual Analogue Scale
2
Description
Distal motor latency of median nerve
Timepoint
First session and last session
Method of measurement
Electrodiagnostic set up
3
Description
Distal sensory latency of median nerve
Timepoint
First session and last session
Method of measurement
Electrodiagnostic set up
Secondary outcomes
1
Description
Hand grip strength
Timepoint
First session and last session
Method of measurement
Dynamometer
2
Description
Pinch strength
Timepoint
First session and last session
Method of measurement
Dynamometer
Intervention groups
1
Description
First Intervention group: laser therapy: low-power diode laser, with wavelength of 830 nm and at a dose of 9 J/cm2 on two points of 2 cm2 over median nerve, in wrist area, for two weeks (10 session) as 5 sessions per week.
Category
Rehabilitation
2
Description
Second Intervention group: ultrasound therapy: Ultrasound treatment including: 15 minutes per session to the area over the carpal tunnel at a frequency of 1 MHz and an intensity of 1.2 W/cm2, with pulsed mode duty cycle of 1:4 and a transducer area of 5 cm2 for two weeks (10 sessions) as 5 sessions per week.
Category
Rehabilitation
3
Description
Third Intervention group: laser therapy with ultrasound therapy: Laser therapy (similar to the Lasre group) follow by ultrasound therapy (similar to the ulrtasound group) for two weeks (10 session) as 5 sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobasher clinic
Full name of responsible person
Mohammad Reza Asadi
Street address
Mahdieh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3832 7512
Email
reza.asadi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School, Hamedan univercity of Medical sciences,Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
reza.asadi21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hamedan univercity of medical sciences, Famideh Blvd,
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3423 0949
Fax
Email
m.asadi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hamedan univercity of medical sciences, Famideh Blvd,
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3423 0949
Fax
Email
m.asadi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD