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CTRI Number  CTRI/2021/03/032102 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   “Effect of structured group exercise program in farmers with non-specific low back pain"  
Scientific Title of Study   “Effect of structured group exercise program in farmers with non-specific low back pain: An-Experimental study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshal parmar 
Designation  MPT 2nd year (CBR) 
Affiliation  Kaher institute of physiotherapy 
Address  KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka.
KAHER INSTITUTE OF PHYSIOTHERAPY,KLE,NEHRU NAGAR,BELAGAVI-590010
Belgaum
KARNATAKA
590010
India 
Phone  9372874294  
Fax    
Email  harshalp036@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prashant naik 
Designation  ASSISTANT PROFESSOR DEPARTMENT OF COMMUNITY PHYSIOTHERAPY AND REHABILITATION 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9743233382  
Fax    
Email  mptnaik@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Harshal parmar 
Designation  MPT 2nd YEAR(CBR) 
Affiliation  Kaher institute of physiotherapy 
Address  KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9372874294  
Fax    
Email  harshalp036@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Reseasrch Nehru Nagar Belagavi 
 
Primary Sponsor  
Name  KLE academy of higher education and research 
Address  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH.INSTITUTE OF PHYSIOTHERPY JNMC CAMPUS BELAGVI. 
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 
HARSHAL PARMAR  KAHER institute of physiotherapy  39-department of community physiotherapy and rehabilitation,kaher institute of physiotherapy,jnmc campus, nehru nagar, belagavi-59-00010, karnataka
Belgaum
KARNATAKA 
9372874294

harshalp036@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIPT Institutional Research and Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  non specific low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  none  none 
Intervention  structured group exercise  2.Stretching and strengthening exercise.(25 minutes) A.Stretching exercise. Hamstring, TA, piriformis and iliotibial band stretching (10sec hold, 3 repetition). Bending forward and backward in standing with holding position for 10 sec.(10sec hold,3 repetitions). B.Strengthening exercises. Isometric exercises, abdominal tights, partial curls, supine bridging, prone bridging, side line bridging, then progression to Pilates exercises. 
Intervention  structured group exercise  1.Warm up exercises.(5 minutes) A.Walking forward and backward. B.Walking sideways. C. Spot marching. D. Spot jumping.  
Intervention  structured group exercise  3. Cool down exercises.(5 minutes). Lying down for 2 minutes followed by Jacobson’s relaxation technique. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Farmers of all gender between age group of 30-60 years.
2.With more than 40% of disability score on modified oswestry low back pain disability questionnaire.
3.Farmers working for more than 7-8 hours per day.
4.Willing to participate in study.
 
 
ExclusionCriteria 
Details  1.Farmers with recent history of any fractures or trauma.
2.With any neurological disorders.  
3.Any spinal or disc pathology.
4.Lumbar spondylosis, cauda equina syndrome, lumbar canal stenosis.
5.Farmers taking any medications.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.ICF (international classification of functioning, disability and health).
2.Pain pressure threshold algometry.
3.Modified oswestry low back pain disability questionnaire.
4.Range of motion (Goniometer).
5.Numerical pain rating scale (NPRS).
 
At baseline and after completion of intervention. i.e 6 weeks intervention 
 
Secondary Outcome  
Outcome  TimePoints 
ICF  PRE and POST intervention
6 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/03/2021 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Back disorders are major cause of sickness,absence and disability in working population and incidence of low back pain rises sharply in early adulthood. Low back pain has multifactorial etiology and complex pathogenesis as it is considered to be dynamic and fluctuating condition. For literally hundreds of years the back has been symbol of strength and focus of stress. In 20th century back pain was major factor of medical disaster. The back pain affects up to 85%-90% of  the population at some stage of their lives.

Musculoskeletal disorders involves wide  range of conditions such as low back pain, osteoarthritis, tennis elbow, golfers elbow, frozen shoulder but among all this conditions the incidence of low back pain is at peak in elderly working population. Farming has been consider a high risk occupation for musculoskeletal disorders.as it is associated with high workload especially with heavy lifting, bending, twisting, carrying load and heavy exposure to vibration. The prevalence of low back pain is 60% among farmers as compared to other musculoskeletal disorders.

In recent decade the principle key elements in treatment of low back pain have largely been pain relieving techniques such as traction ,relaxation, rest and prevented exercises. supervised group exercise, as an adjunct to usual care, would improve  pain, range of motion, level of functioning and quality of life for individuals with musculoskeletal disorders and that benefits would be maintained for six months to 1 year the intervention.

 
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