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CTRI Number  CTRI/2024/12/077866 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
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   To compare and check the effect of two exercises one where i am giving back exercise with psychological councelling and in other exercise on physio ball for back pain  
Scientific Title of Study   To compare the effect of back school program vs swiss ball exercise on pain flexibility and disability among individuals with non specific back pain : A comparative study  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandini Yadav  
Designation  MPT scholor  
Affiliation  Parul institute of physiotherapy  
Address  Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat

Vadodara
GUJARAT
391760
India 
Phone  8147382134  
Fax    
Email  nandinigeeta1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavana Gadhavi 
Designation  Dean and principal 
Affiliation  Parul institute of physiotherapy  
Address  Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat

Vadodara
GUJARAT
391760
India 
Phone  9727729787  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavana Gadhavi 
Designation  Dean and principal 
Affiliation  Parul institute of physiotherapy  
Address  Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat


GUJARAT
391760
India 
Phone  9727729787  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Room no 309 3rd floor Department of Physiotharapy Parul university post limda waghodia Vadodara 391760 Gujarat India 
 
Primary Sponsor  
Name  parul university  
Address  room no 309 3 nd floor department of physiotharapy parul university post limda waghodia gujarat  
Type of Sponsor  Private medical college 
 
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 Nandini yadav   Parul university   Room no 309 3rd floor Department of Physiotharapy Parul University post limda waghodia Vadodara 391760 Gujarat India
Vadodara
GUJARAT 
8147382134

nandinigeeta1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University(IECHR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  back school program  4 days in a week for 4 weeks. 
Comparator Agent  swiss ball exercise  4 days in a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1) Willingness of subjects
2) Patients diagnosed with non-specific low back pain
3)Patients with minimum to moderate disability up to 40% on MODI
4)Patients with VAS grade of 5 and below
5)Age group between 18- 35 years
6)Both Male and Female 
 
ExclusionCriteria 
Details  1)Spinal tumour or other malignancy.
2)Medicine for psychiatric disorder.
3)Lumbar stenosis spondylitis, spondylolisthesis,
4)Neuromuscular disease of back
5)Presence of any lumbar Spinal or disc pathologies.
6)Presence of any Recent injury or Trauma.
7)Cauda equina syndrome that requires urgent surgery.
8)pregnant patients
9)joint disfunction
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
visual analog scale   4 days in a week for 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Modified oswestry low back pain disability sacle  1 day , last day in 4 weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 

NEED OF STUDY

   Low back pain is a prevalent musculoskeletal condition globally considered a primary cause of years lived with disability It imposes a significant economic burden due to healthcare expenses reduced productivity, insurance costs, and sick leave. 

Non-specific low back pain is discomfort in the lower back without a clear identifiable cause and pathology.

Back school programs typically involve education and exercises aimed at improving back health and function. On the other hand, Swiss ball exercises are one of the dynamic exercises, and the main principle is to reduce low back pain by increasing muscle strength, endurance, balance, and flexibility of the trunk while the individual leans on the Swiss ball. Both the intervention emphasizes on strength flexibility and core and core activation but back school program include knowledge and awareness through counselling as well as managing psychosocial aspect of pain so here arises a need to find out whether managing patient as a whole creates a difference in outcome or not

Individually, both the Back School Program and Swiss Ball Stabilization Exercise have shown promise in reducing pain, improving flexibility, and enhancing functional capacity among individuals with NSLBP but there is a notable absence of research exploring the combined effects of these interventions.

However, a comparative assessment of these interventions is lacking in the current literature. Understanding the relative efficacy of these interventions is crucial for optimizing treatment outcomes and informing evidence-based practice in the management of NSLBP.  The proposed comparative study aims to address this gap by directly comparing the effects of the Back School Program and Swiss Ball Stabilization Exercise on pain, flexibility, and disability among individuals with NSLBP. By conducting a rigorous comparative analysis, the study seeks to elucidate whether one intervention is superior to the other or if both exercises are equally effective.


 
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