Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000841976
Ethics application status
Approved
Date submitted
19/05/2011
Date registered
10/08/2011
Date last updated
10/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of low-power laser in amelioration of pain , dysesthesia and Lhermitte’s sign in multiple sclerosis patients
Scientific title
The efficacy of low-power laser in addition to Gabapentin, compared to treatment with Gabapentin alone in the amelioration of pain and improvement of quality of life in multiple sclerosis patients
Secondary ID [1] 262136 0
Nil
Universal Trial Number (UTN)
U1111-1121-2292
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 265814 0
pain 267994 0
Quality of life 267996 0
dysesthesia 268303 0
Lhermitte's sign 268304 0
Condition category
Condition code
Neurological 265966 265966 0 0
Multiple sclerosis
Anaesthesiology 268126 268126 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
different Probe that will be used on cervical and thoracic spinal culomn one after another:
1) MLO1K: Helium, Neon, Argon Amplitude: 500-670 nm Duration: 1-5 min Power: 20 j/cm2
2) KLO6: Helium, Neon Amplitude: 500-670 nm Duration: 10-40 second Power: 172 j/cm2
3) KLO3: Helium, Neon Amplitude: 500-670 nm Duration: 10-30 second Power: 10/5 j/cm2
4) RED Amplitude: 500-660 nm Power: 10/9 j/cm2

Duration of laser therapy in each session: 10-15 min
Location: cervical and thoracic spinal cord
Frequency of sessions: once daily for 10 days(5 continuous days, 2 days rest, and another 5 continuous days)

Laser and Gabapentin capsule (300mg/day) will be administered simultaneously.
Intervention code [1] 264582 0
Treatment: Drugs
Intervention code [2] 266682 0
Treatment: Devices
Comparator / control treatment
Sham therapy for 10 session plus Gabapentin capsule(300mg/day) once daily for 10 days(5 continuous days, 2 days rest, and another 5 continuous days).
For the patients who should receive sham therapy, operator use the turned off laser probe
Control group
Placebo

Outcomes
Primary outcome [1] 266757 0
Visual analogue scale score for pain.
Timepoint [1] 266757 0
Just after the last session and 2 weeks after that.
Secondary outcome [1] 276317 0
SF-36 questionnaire for quality of life.
Timepoint [1] 276317 0
Just after last session and 2 weeks after that.

Eligibility
Key inclusion criteria
Definitive diagnosed MS with MC-donald 2010 criteria
Cervical pain, Lhermitte's sign, painful dysesthesia in upper limbs or pain in lumbar and pelvic regions and dysesthesia in shoulder girdle.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MS attack or need for corticosteroid pulses.
Addiction or using drugs simultaneous with therapy.
Simultaneous using of regular powerful anti-inflammatory drugs
Other causes except than spinal cord plaques produce pain, dysesthesia and Lhermitte's sign.

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)
Randomization will be done by person who is not involved in enrolling the patients and writes intervention group(A or B) in sealed opaque envelopes after determining its sequence. thereafter people who are undertaking enrolling, after checking the inclusion and exclusion criteria, open the envelope to determine the intervention group of each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each group(laser/sham) are named A or B by someone who is not involved in enrolling, evaluation and analysis. According to randomization table, sequence of block will be defined. (Permuted block randomization)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 3582 0
Iran, Islamic Republic Of
State/province [1] 3582 0

Funding & Sponsors
Funding source category [1] 267080 0
University
Name [1] 267080 0
Tehran University of medical sciences
Country [1] 267080 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran university of medical sciences
Address
Poor sina St, Enghelab Sq,
Tehran,
Iran
postal/ZIP: 1417613151
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 264169 0
Individual
Name [1] 264169 0
Masood Nabavi
Address [1] 264169 0
Mostafa Khomein hospital, Italia ST,
Tehran,
Iran

Postal/ZIP: 141665185
Country [1] 264169 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269380 0
Ethic committee of Tehran University of medical science
Ethics committee address [1] 269380 0
Ethics committee country [1] 269380 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 269380 0
Approval date [1] 269380 0
Ethics approval number [1] 269380 0

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

Contacts
Principal investigator
Name 32586 0
Address 32586 0
Country 32586 0
Phone 32586 0
Fax 32586 0
Email 32586 0
Contact person for public queries
Name 15833 0
Sadeghi Naini, Mohsen
Address 15833 0
Num29, Karimi Alley, Arash Blv, Zafar St.
Tehran
Iran
Postal/ZIP: 1916649411
Country 15833 0
Iran, Islamic Republic Of
Phone 15833 0
+989124934734
Fax 15833 0
Email 15833 0
[email protected]
Contact person for scientific queries
Name 6761 0
Nabavi, seyed masoud
Address 6761 0
Mostafa Khomeini Hospital
Vesal St., Italia St.
Tehran
Iran
Postal/ZIP 141665185
Country 6761 0
Iran, Islamic Republic Of
Phone 6761 0
+982188963122
Fax 6761 0
Email 6761 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.