Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000701224
Ethics application status
Approved
Date submitted
28/06/2009
Date registered
13/08/2009
Date last updated
13/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laser therapy versus local steroid injection for carpal tunnel syndrome
Scientific title
A randomised controlled trial of the effect of low level laser therapy versus local steriod injection on nerve conduction in those with carpal tunnel syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 237108 0
Condition category
Condition code
Neurological 237436 237436 0 0
Other neurological disorders
Neurological 239682 239682 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
laser therapy was administered by applying a Infrared laser diode in characteristics of 775 nm amplitude, 6500 Hz frequency and an intensity of 20 at five points over 11 seconds along the median nerve passage above the carpal tunnel. A total of 10 laser therapies were performed every other day for 3 week. In Steroid injection group 50mg Hydrocortisone (2 ml) was injected into the carpal tunnel only once. The wrist was positioned on a hard surface in slight dorsiflexion and the needle was advanced at 30-degree angle to the skin, medial to the palmaris longus.
Intervention code [1] 236828 0
Treatment: Other
Comparator / control treatment
This study assess low level laser versus steroid injection for carpal tunnel syndrome
Control group
Active

Outcomes
Primary outcome [1] 238233 0
nerve conduction study was assessed by electrodiagnostic study.
Timepoint [1] 238233 0
at baseline and 8 weeks after treatment
Primary outcome [2] 238234 0
nerve conduction study
Timepoint [2] 238234 0
at baseline and 8 weeks after treatment
Secondary outcome [1] 257031 0
Nil
Timepoint [1] 257031 0
Nil

Eligibility
Key inclusion criteria
mild to moderate carpal tunnel syndrome without previous treatment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe carpal tunnel syndrome,previous treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment outside Australia
Country [1] 1857 0
Iran, Islamic Republic Of
State/province [1] 1857 0

Funding & Sponsors
Funding source category [1] 237219 0
Hospital
Name [1] 237219 0
501 army hospital
Country [1] 237219 0
Iran, Islamic Republic Of
Primary sponsor type
Hospital
Name
501 army hospital
Address
western Fatemi street, Tehran,Iran
postcode:123215433
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 4711 0
None
Name [1] 4711 0
Address [1] 4711 0
Country [1] 4711 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29806 0
Address 29806 0
Country 29806 0
Phone 29806 0
Fax 29806 0
Email 29806 0
Contact person for public queries
Name 13053 0
mahsa asheghan
Address 13053 0
36 no, Zartoshtian street,Tehran,Iran.
postcode:1436913511
Country 13053 0
Iran, Islamic Republic Of
Phone 13053 0
+982188058837
Fax 13053 0
Email 13053 0
[email protected]
Contact person for scientific queries
Name 3981 0
mahsa asheghan
Address 3981 0
University of social welfare and rehabilitation,Evin street, Tehran,Iran.
postcode:1316785754
Country 3981 0
Iran, Islamic Republic Of
Phone 3981 0
+982188058837
Fax 3981 0
Email 3981 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.