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CTRI Number  CTRI/2024/05/067852 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing traditional therapy to bilateral hip muscle strengthening for students experiencing non specific low back pain 
Scientific Title of Study   Comparison of bilateral hip muscle strengthening with conventional therapy in students with non-specific chronic low back pain: A 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  Lucky Khandelwal 
Designation  Post graduate student 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be university) 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8233247011  
Fax    
Email  luckykhandelwal47011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saumya Srivastava 
Designation  Associate Professor 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be university) 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Lucky Khandelwal 
Designation  Post graduate student 
Affiliation  NITTE Institute of Physiotherapy, NITTE (Deemed to be university) 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8233247011  
Fax    
Email  luckykhandelwal47011@gmail.com  
 
Source of Monetary or Material Support  
NITTE Institute of Physiotherapy, NITTE (Deemed to be unversity) will provide basic infrastructure facilities. no other monitary support is required 
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy NITTE deemed to be university 
Address  Department of Physiotherapy, room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, 575018, India 
Type of Sponsor  Other [self] 
 
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 
Lucky Khandelwal  Nitte Institute of Physiotherapy  Room number 20, Department of Physiotherapy,second base division , Justice K.S. Hedge Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA 
8233247011

luckykhandelwal47011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of NITTE Institute of Physiotherapy  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 physical therapy  The patients will perform an average of three series of 10 repetitions of each exercise. For all exercises, the final static position will be held for 8 sec. There will be a pause of 3 seconds between repetitions and a 60-sec rest between each exercise, there will be an increase in the number of repetitions or load progression according to individual tolerance. A single session will take 30 minutes to complete, treatment will be given for 3 times in a week for 4 weeks. 1) Traditional curls up 2) Single Knee to chest 3) Bridging 4) Prone on elbow 5) Prone on hands 6) Prone hip extension 7) Trunk extension  
Intervention  Hip strengthening protocol   Exercises will be performed for a frequency of 3 sets of 10 repetitions for each side hold for 10 seconds, and there will be increase in the number of repetitions or load progression according to individual tolerance.A single session will take 45 minutes to complete, treatment will be given 3 times in a week for 4 weeks. 1) Clam shell with resistance band 2) Side lying hip abduction with resistance band 3) Squat with resistance band 4) Lateral stepping with resistance band  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  1) University students of various institutions under Nitte Deemed to be university
2) Age 18-28 years old
3) Nonspecific chronic low back pain
4) Pain intensity on NPRS with a score between 3 to 8
5) BMI range of 18.4 – 24.9 
 
ExclusionCriteria 
Details  1) Participants with a history of trauma or surgery to the lumbar spine, abdomen,
pelvis, or lower limb in the past 1 year
2) Participants reporting spinal deformity (scoliosis, spondylolysis, spondylolisthesis,
spinal stenosis, or PIVD)
3) Participants with a history of spinal and pelvis fracture in the past 3 months
4) Participants who are taking corticosteroids or anti-inflammatory medication
currently
 
 
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 
Pull and Push Dynamometer, Numeric Pain Rating Scale  Once the individual is included in the study, readings will be taken as baseline values and after 4 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Scale,
Single Leg stance test 
Once the individual is included in the study, readings will be taken as baseline values and after 4 weeks of treatment. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Nonspecific low back pain (NSLBP) is described as low back discomfort with no discernible, well-known pathophysiology, that is not caused by a specific condition. Many diagnoses by researchers have led to the conclusion that no important reason or disease is causing NSLBP. Pain in the lower back region might be caused by lifting large weights by age-related changes in the spine over time or by prolonged sitting in faulty posture in front of laptops or mobiles.
Students attend classroom sessions for theory input while also working in front of computers to search for materials, which requires prolonged sitting in most of their everyday activities. Prolonged sitting has become one of the factors causing musculoskeletal discomfort, particularly among university students who have LBP, which is often reported and highly connected with individual variables, work ergonomics, and incorrect posture and mobility. Postural pain is the pain caused by mechanical tension when a person maintains a bad posture for an extended period; the pain is usually eased by movement. There are no functional strength or flexibility limitations, but if the poor posture persists, strength and flexibility imbalances emerge. Chronic NSLBP patients experience pain, muscle atrophy, decrease in muscle strength, endurance, and flexibility these all occur as a result of the long-term reduction in trunk activity and disuse, which aggravates low back pain and causes secondary lumbar segment damage and physical disability. When compared to healthy people, those suffering from low back pain have less capacity to maintain balance. When the human body is subjected to an unexpected load, the muscles should respond quickly to maintain balance and posture against the load, but 3 patients with low back pain have a delayed response time, causing a problem with balance.
The prevalence of low back pain among university students is particularly significant due to their prolonged sitting with laptops and mobile phones in poor posture. Many factors influence low back pain in university students, including anthropometric data in individual’s twenties, physiological structure, genetic factors, age, gender, smoking, computer work duration, lumbar support usage, school furniture, sitting position, physical activity, and socioeconomic situations. Studies that have evaluated the hip muscles in chronic NSLBP patients found that there is a significant weakness in hip abductors, adductors, and extensors compared to healthy individuals, which increases the need for administrating the hip muscle strengthening protocol in the physical therapy protocols normally used. Some studies have used the hip strengthening protocol with other conventional therapies they have only targeted the hip abductors and extensors and concluded that the group with the hip strengthening protocols was having better and significant improvement in strength, pain disability, and balance but the population taken was of age 30-50 years of age. There is a clear gap in the literature to test the effectiveness of hip strengthening protocol for non-specific chronic low back pain in the student population. 
This study aims to compare bilateral hip muscle strengthening with conventional treatment in students with chronic NSLBP. We hypothesized that the addition of hip strengthening exercises to a conventional exercise would result in an increase in strength, a reduction in pain and disability, and improved balance ability. The test components included will be hip muscle strength measurement using a dynamometer with a reliability of 0.98. The numeric pain Rating Scale (NPRS) consisted of 11 points; it exhibits moderate reliability ICC = 0.67; (0.27 – 0.84]. [4] To determine the level of disability caused by LBP, the Oswestry disability index (ODI) is utilized. The ICC value of ODI is 0.93. The single-leg standing test is used to assess LBP patients’ static balance skills. The suggested single-leg stance balancing test is a valid technique for evaluating balance.
 
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