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CTRI Number  CTRI/2020/03/023839 [Registered on: 09/03/2020] Trial Registered Prospectively
Last Modified On: 08/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of high-intensity in chronic non-specific low back pain. 
Scientific Title of Study   Evaluation of the different effects of high-intensity versus low-level laser therapy on patients with chronic non-specific low back pain: randomized control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gopal Nambi 
Designation  Asociate Professor 
Affiliation  Prince Sattam Bin Abdul AZIZ University, Al-Kharj, Saudi Arabia 
Address  Dept Of Physical Therapy, Prince Sattam Bin Abdul AZIZ University, Al-Kharj, Saudi Arabia



11942
Other 
Phone    
Fax    
Email  physio_gopal@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gopal Nambi 
Designation  Asociate Professor 
Affiliation  Prince Sattam Bin Abdul Aziz University, Al-Kharj, Saudi Arabia 
Address  Dept Of Physical Therapy, Prince Sattam Bin Abdul AZIZ University, Al-Kharj, Saudi Arabia



11942
Other 
Phone    
Fax    
Email  physio_gopal@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Gopal Nambi 
Designation  Asociate Professor 
Affiliation  Prince Sattam Bin Abdul Aziz University, Al-Kharj, Saudi Arabia 
Address  Dept Of Physical Therapy, Prince Sattam Bin Abdul AZIZ University, Al-Kharj, Saudi Arabia



11942
Other 
Phone    
Fax    
Email  physio_gopal@rediffmail.com  
 
Source of Monetary or Material Support  
Dept of Physical Therapy, College of Applied medical sciences, Prince Sattam Bin Abdul Aziz University, Al Kharj, Saudi Arabia 
 
Primary Sponsor  
Name  Prince Sattam Bin Abdul Aziz University  
Address  Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Saudi Arabia  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gopal Nambi  Prince Sattam Bin Abdul Aziz University  Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.

 		 501878382

physio_gopal@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Department Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High intensity LASER  BTL-6000 HILT was used. The device use gallium-arsenide diode laser (BTL-6000 laser) and manually set to biostimulation mode with power of 12 W, 150 J/cm2, wavelength of 1064 nm, and patch radiation diameter zone of 1 cm2. Under these cases, laser was applied with constant movements. In each session, total energy applied to subject measured 1500 J, 4 sessions per week for 6 weeks (24 sessions). 
Comparator Agent  Low intensity Laser  The gallium-aluminum-arsenide (GaAlAs, infrared laser) diode laser device (Chattanooga group, USA) with a wavelength of 850 nm, power output of 100 mV, constant wave with spot size of 0.07 cm was used for the treatment. The laser was applied at energy of approximately 40 J/cm2. Laser device was used with a pulse frequency of 155 Hz for chronic nsLBP, 4 sessions per week for 6 weeks (24 sessions). 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) history of low back pain lasting more than 3 months; b) over 25 years of age; c) ability to comply with any of the randomly selected treatment programs. 
 
ExclusionCriteria 
Details  neurological defects, unusual laboratory findings, fracture, spondylosis, spinal stenosis, inflammatory disease, infectious diseases, mental conditions, prior spinal surgery and pregnancy. Subjects who have received any type of treatment for back pain in the last three months were also been removed. Consent forms were obtained from each participant before initiating the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oswestry disability index (ODI), visual analogue scale (VAS), lumbar flexion range of motion (ROM)  Before and after 6 weeks intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  Before and after 6 weeks intervention  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic non-specific low back pain (chronic nsLBP) is very common and prevalent among population worldwide. Laser therapy was used in the treatment of chronic LBP while very limited studies have assessed the effects of high-intensity laser therapy (HILT) versus low-level laser therapy (LLLT) on chronic nsLBP. This study aimed to evaluate the effects of HILT versus LLLT on patients with chronic nsLBP.

 
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