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CTRI Number  CTRI/2021/03/031736 [Registered on: 05/03/2021] Trial Registered Prospectively
Last Modified On: 04/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of Yoga therapy in university professors with chronic low back pain 
Scientific Title of Study   Comparative effects of Yoga therapy and Proprioceptive neuromuscular training on clinical outcomes and psychosocial effects in university professors with chronic low back pain – A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gopal Nambi 
Designation  Associate Professor 
Affiliation  Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. 
Address  Department of Physical Therapy and Health Rehabilitation, College of Applied medical sciences, Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.
Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.


11942
Other 
Phone  00966501878382  
Fax    
Email  physio_gopal@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gopal Nambi 
Designation  Associate Professor 
Affiliation  Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. 
Address  Department of Physical Therapy and Health Rehabilitation, College of Applied medical sciences, Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.
Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.


11942
Other 
Phone  00966501878382  
Fax    
Email  physio_gopal@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Gopal Nambi 
Designation  Associate Professor 
Affiliation  Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. 
Address  Department of Physical Therapy and Health Rehabilitation, College of Applied medical sciences, Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.
Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia.


11942
Other 
Phone  00966501878382  
Fax    
Email  physio_gopal@rediffmail.com  
 
Source of Monetary or Material Support  
Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. 
 
Primary Sponsor  
Name  Prince Sattam Bin Abdulaziz University Al Kharj Saudi Arabia 
Address  Department of Physical Therapy and Health Rehabilitation, College of Applied medical sciences, Prince Sattam Bin Abdulaziz University, Al- Kharj, 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, Al- Kharj, Saudi Arabia.

 		 00966501878382

physio_gopal@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Proprioceptive neuro muscular facilitation exercise  The participants will attend training session lasting for about 30---40 min three times a week. They will receive three sets of 15 repetitions for each PNF training, with a 30 s rest between repetitions. A 60 second rest after completing the 15 repetitions will be provided. The training intervention was divided into three phases and progression of training was based on the individual’s performance. For week 1 and 2, the participants will be trained in alternate isometric contractions of the trunk flexors and extensors against maximum force. The training will be provided by the physical therapist for 10 seconds in a sitting position. For week 3 and 4, the participants will concentrate in alternating isometric concentric and eccentric contractions of the trunk agonistic muscles with a 5 second resisted concentric contraction of the trunk flexors in forward bending, followed by a 5 s resisted eccentric contraction of the trunk flexors in the return to trunk neutral position and a 5 s hold resisted isometric contraction of the trunk muscles in a neutral position. The same method was applied in the backward bending of the trunk. For week 5 to 8, the participants will focus on training the upper extremities by alternately performing the chop and lift movement patterns in diagonal and spiral directions for 10 seconds. The maximum resistance will be generated by the physical therapist  
Intervention  Yoga therapy  The intervention consisted of 29 postures. Poses from the following categories will be used: Supine, seated, standing, forward bends, twists, and inversions. No back bending poses will be introduced at this stage of recovery to reduce the risk of re injury. Back bending poses require a proper progression of musculoskeletal retraining and can be harmful if done without implementation of complex musculoskeletal actions. Before doing yoga soft tissue flexibility and range of motion exercises will be taught to these patients with 5 - 10 min relaxation periods (warm up). The yoga program will be performed 3 days a week with 5 repetitions in 3 sets with 30.seconds pauses per set to begin with and repetitions and it will gradually increase until they reach 15. During yoga, importance of neutral spinal position will be repeatedly stressed. The entire program will lasted for 8 weeks.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Male university professors in the age group of 30 to 60 years, chronic ( more than 3 months) LBP and 4 to 8 pain intensity in visual analogue scale (VAS) will be included. 
 
ExclusionCriteria 
Details  Participants with severe musculoskeletal, neural, somatic, and psychiatric conditions, waiting for spine surgery, having alcohol or drug abuse, involving in other weight and balance training program will be excluded from the study. Participants with other soft tissue injuries, fracture at the lower limbs and pelvic bone, deformities will also be excluded from the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale  Baseline, after 4 weeks, 8 weeks and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Range of motion
Functional disability
Muscle cross sectional area
Quality of life 		 Baseline, after 4 weeks, 8 weeks and 6 months 
 
Target Sample Size   Total Sample Size="76"
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   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   Will publish in Web of science (ISI) indexed journal. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Yoga and exercise interventions are usually delivered in physical therapy program in chronic low back pain. It includes different postures applied for the joints and other structures, Yoga therapy and other different forms of exercises are delivered by various clinicians, including yoga specialists, physiotherapists, physical therapists, chiropractors and osteopaths. The aims of both types of interventions are to relieve pain, promote healing, reduce muscle spasms, increase joint range, strengthen weakened muscles and improve biomechanics and function. Hence this study is trying to find its different effects in chronic low back pain. 
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