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CTRI Number  CTRI/2025/08/092200 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   In our study we will be including patients with chronic low back pain. We will be giving trunk balance exercises and conventional physiotherapy exercises wearing strobe glasses to see its effect on disability, pain and kinesiophobia. 
Scientific Title of Study   Effectiveness of Stroboscopic visual training with trunk balance exercises on disability, pain and kinesiophobia in chronic low back pain patients: A Pilot Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Pillay  
Designation  Postgraduate student  
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy, Department of Musculoskeletal, OPD-1, ground floor, N6, Cidco, Chhatrapati Sambhajinagar , Maharashtra, India

Aurangabad
MAHARASHTRA
431003
India 
Phone  7821915900  
Fax    
Email  divyapillay7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanket Mungikar  
Designation  Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy,Department of Musculoskeletal, OPD-1, ground floor, N6, Cidco, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431003
India 
Phone  9730770107  
Fax    
Email  sanketmungikar@mgmiop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sanket Mungikar  
Designation  Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy, Department of Musculoskeletal, OPD-1, ground floor, N6, Cidco, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431003
India 
Phone  9730770107  
Fax    
Email  sanketmungikar@mgmiop.edu.in  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy N6 Cidco, Chhatrapati Sambhajinagar, 431003 Maharashtra, India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy  
Address  MGM Institute of Physiotherapy,Department of Musculoskeletal, OPD-1, ground floor,N6 Cidco, Chhatrapati Sambhajinagar, Maharashtra, India, 431003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Pillay  MGM Physiotherapy Rehabilitation and Fitness Centre  Musculoskeletal Physiotherapy Department, OPD 1, MGM Institute of Physiotherapy, N6 Cidco, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA 		 7821915900

divyapillay7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy exercises  1. Interferential current: Tetrapolar application (Beat frequency: 150 Hz Session: 25 minutes for 2 weeks) 2. Hot moist pack: 2 times/ day 3. Transversus abdominus: Abdominal bracing, Bracing with heel slides , Bracing with leg lifts , Bracing with bridging. 4. Quadratus lumborum and obliques: Side plank with knees flexed , Side plank with knees extended. 5. Trunk curl 
Intervention  Strobe glasses with trunk balance exercises and conventional physiotherapy  Trunk balance exercises : (Each exercise 10 reps-2 sets, 45 minutes/ session, 4 days /week for 6 weeks). 1. Kneeling on a pillow and arms abducted to 90°, rotate the trunk, head and upper limbs alternately in both the direction maintaining each position for 30 seconds. Progression: Performing the above-mentioned exercise wearing strobe glasses with head extension maintaining each position for 30 seconds. 2. Kneeling on a pillow, move the upper limbs in flexion and extension, with a simultaneous movement of the head. The position is maintained for 3 minutes. Progression: Performing the above-mentioned exercise wearing strobe glasses. The position is maintained for 3 minutes. 3. From the quadruped position extend opposite arm and leg. The position is maintained for 1 minute for each combination of limbs. Progression: Performing the above-mentioned exercise while keeping a pillow under the lower limb. The position is maintained for 1 minute for each combination of limbs. Progression: Performing the above-mentioned exercise while wearing strobe glasses.The position is maintained for 1 minute for each combination of limbs. 4. Sitting on the side of the table with unilateral support. This position is maintained for 1 minute each side. Progression: Sitting on the side of the table with unilateral support and crossing the upper arms to the chest with head extension with a pillow under the lower limb. This position is maintained for 1 minute each side. Progression: Performing the above-mentioned exercise with strobe glasses. This position is maintained for 1 minute each side. 5. Single-limb kneeling on the edge of the table with a pillow under the knee. The position is maintained for 30 seconds. Progression: Performing the above-mentioned exercise with head extension and arm across the chest. The position is maintained for 30 seconds. 6. Single-limb kneeling on the edge of the table with a pillow under the knee with head extension and arm across the chest while wearing strobe glasses. The position is maintained for 30 seconds.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Back Performance Scale ( 8-15 score moderate to severe disability).
2.Pain on Numeric Pain Rating Scale (1-5 score mild to moderate pain).
3.Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks , American Pain Society Pain Taxonomy (AAPT) Diagnostic Criteria for Chronic
Musculoskeletal Low Back Pain. 
 
ExclusionCriteria 
Details  1.Spine surgery within the previous six months.
2.Inflammatory arthritis (Rheumatoid arthritis, Ankylosing spondylitis).
3.Presence of neurological symptoms or deficit (eg, spontaneous paresthesias or motor deficit localizing to a nerve root distribution) or symptoms in the lower extremities (eg,spontaneous paresthesias). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Disability  Pre and Post Intervention Period (6 week) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain   Pre and Post Intervention Period (6 week) 
Kinesiophobia  Pre and Post Intervention Period (6 week) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Patients with Chronic low back pain will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Baseline data which include Disability, pain and  kinesiophobia will be assessed. The patients will be randomly divided into two study groups intervention group and control group. The patients will receive intervention as per the group allocation for 6 weeks. The intervention group will receive Trunk balance exercises in addition to the conventional physiotherapy whereas the control group will receive conventional physiotherapy only. Trunk balance exercises include  1. Kneeling on a pillow and arms abducted to 90°, rotate the trunk, head and upper limbs alternately in both the direction maintaining each position for 30 seconds. Progression: Performing the above-mentioned exercise wearing strobe glasses with head extension maintaining each position for 30 seconds. 2. Kneeling on a pillow, move the upper limbs in flexion and extension, with a simultaneous movement of the head. The position is maintained for 3 minutes. Progression: Performing the above-mentioned exercise wearing strobe glasses. The position is maintained for 3 minutes. 3. From the quadruped position extend opposite arm and leg. The position is maintained for 1 minute for each combination of limbs. Progression: Performing the above-mentioned exercise while keeping a pillow under the lower limb. The position is maintained for 1 minute for each combination of limbs. Progression: Performing the above-mentioned exercise while wearing strobe glasses.The position is maintained for 1 minute for each combination of limbs. 4. Sitting on the side of the table with unilateral support. This position is maintained for 1 minute each side. Progression: Sitting on the side of the table with unilateral support and crossing the upper arms to the chest with head extension with a pillow 16 under the lower limb. This position is maintained for 1 minute each side. Progression: Performing the above-mentioned exercise with strobe glasses. This position is maintained for 1 minute each side. 5. Single-limb kneeling on the edge of the table with a pillow under the knee. The position is maintained for 30 seconds. Progression: Performing the above-mentioned exercise with head extension and arm across the chest. The position is maintained for 30 seconds. 6. Single-limb kneeling on the edge of the table with a pillow under the knee with head extension and arm across the chest while wearing strobe glasses. The position is maintained for 30 seconds. ( All exercises will be performed for 10 reps - 2 sets, 45 minutes/session, 4 days/week for 6 weeks) . 
Conventional Physiotherapy Includes  Interferential current : Tetrapolar application (Beat frequency: 150 Hz Session: 25 minutes for 2 weeks)  , Hot moist pack: 2 times/ day ; Transversus abdominus : 1. Abdominal bracing . 2. Bracing with heel slides . 3. Bracing with leg lifts . 4. Bracing with bridging ; Quadratus lumborum and obliques : 1. Side plank with knees flexed 2. Side plank with knees extended ; Trunk curl. ( All exercises will be performed for 10 reps - 2 sets, 45 minutes/session, 4 days/week for 6 weeks). Outcome measures will be assessed pre and post intervention period. Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study.
 
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