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CTRI Number  CTRI/2018/04/013026 [Registered on: 04/04/2018] Trial Registered Prospectively
Last Modified On: 03/04/2018
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   Effect of two different type of exercises on pain,muscle activation and disability in patients with Chronic Low Back Pain 
Scientific Title of Study   A comparative study of conventional exercises versus posterior pelvic tilt and gluteus medius strengthening exercises on pain,muscle activation and disability in patients with chronic low back pain. 
Trial Acronym  no acronym present 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Moazzam Hussain Khan 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre of Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi
230 1st floor, near bhumiya mata mandir gali, Hari nagar Ashram , new delhi- 110014
South
DELHI
110025
India 
Phone  9990307150  
Fax    
Email  mkhan47@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Moazzam Hussain Khan 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia 
Address  Centre of Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi
230 1st floor, near bhumiya mata mandir gali, Hari nagar Ashram ,New Delhi- 110014
South
DELHI
110025
India 
Phone  9990307150  
Fax    
Email  mkhan47@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Parul Sharma 
Designation  postgraduate student  
Affiliation  Jamia Millia Islamia 
Address  Center of Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi
230 1st floor , near bhumiya mata mandir gali, Hari nagar Ashram, New Delhi-110014
South
DELHI
110025
India 
Phone  9650501389  
Fax    
Email  parulsharma1089@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  Jamia Millia Islamia,Mohammad Ali Jauhar Marg,Jamia Nagar 
Type of Sponsor  Other [university] 
 
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 
Parul Sharma  Jamia Millia Islamia  Centre of Physiotherpy and Rehabilitation Sciences ,Jamia Millia Islamia,Mohammad Ali Jauhar Marg,Jamia Nagar, New Delhi-110025
South
DELHI 		 9650501389

parulsharma1089@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Low Back Pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparator- hot pack, exercises  comparator agent-acive control group includes 10 mins hot pack fomentation and exercises. 8-12 repetitions, 30 mins/day for 3 days/week 
Intervention  intervention- hot pack fomentation, exercises  intervention- 10 mins hot pack fomentation and exercises targeting specific muscles including posterior pelvic tilt and gluteus medius strengthening with weights. 8-12 repetitions, 30-40 mins/day, 3 days/week 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  includes people with
1)People with chronic (≥3months) nonspecific Low Back Pain of mechanical origin without radiation to the lower limb.
2)Males/females between 20-50 years
3)People willing to attend a 4-week treatment program
4)Numerical pain rating scale score ≤ 6
5)Revised Oswestry Disability Index score ≤ 50%
6)Lumbar lordosis >35 degree
7)Working knowledge of English
 
 
ExclusionCriteria 
Details  excludes patient with
1)Spinal and abdominal surgery
2)Prolapse Intervertebral Disc/Radicular pain indicative of nerve root compression
3)People diagnosed with severe spinal stenosis, spondylolisthesis.
4)History of systemic/inflammatory disease.
5) Pregnancy
6)Osteoporosis
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
NPRS (For pain Level)
Revised Oswestry Low Back Pain Questionnaire (for determined functional disability)


 		 change from baseline to the end of the treatment


 
 
Secondary Outcome  
Outcome  TimePoints 
Flexicurve (for measuring Lumbar lordosis)
Surface EMG (for measuring muscular activation)
Muscle strength (by Lafayette manual muscle testing system/dynamometer)

 		 change from baseline to the end of the treatment 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   04/04/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no publications yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


The objective of the study under trial is "To compare the effectiveness of posterior pelvic tilt exercises with gluteus medius strengthening versus conventional exercises in patients with chronic Low back pain".

Sample

Patients with chronic low back pain will be taken from C.P.R.S. clinic at Jamia Millia Islamia University, New Delhi, India. Subjects will be assigned to two groups by randomization method. By random allocation, each subject will be distributed in one of the two groups “A” and “B”.  Group “A” subjects will perform conventional physiotherapy exercises and Group “B” subjects will perform posterior pelvic tilt exercises and gluteus medius strengthening exercises.


The significance of the Study

This study will help us to devise a rehabilitation protocol for chronic low back pain focusing on reducing pain, improving functional disability and proximal stability of lower extremity, thus giving us a cost-effective and wholesome approach to the rehabilitation protocol
 
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