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CTRI Number  CTRI/2011/12/002295 [Registered on: 26/12/2011] Trial Registered Retrospectively
Last Modified On: 23/12/2011
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 the effectiveness of a home based self administered exercise program instructed by the doctor with that of conventional supervised physiotherapy in the treatment of chronic mechanical low back pain” 
Scientific Title of Study   “Comparison of the effectiveness of a home based self administered exercise program with that of conventional supervised physiotherapy in chronic mechanical low back pain” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUJITH K R 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM 
Address  DEPT OF PHYSICAL MEDICINE AND REHABILITATION GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM
KIZHAKKE NANGETH KANJIRAMATTOM ERNAKULAM KERALA
Thiruvananthapuram
KERALA
695011
India 
Phone  9995345242  
Fax    
Email  drsujithkr@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  SUJITH K R 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM 
Address  DEPT OF PHYSICAL MEDICINE AND REHABILITATION GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM
KIZHAKKE NANGETH KANJIRAMATTOM ERNAKULAM KERALA
Thiruvananthapuram
KERALA
695011
India 
Phone  9995345242  
Fax    
Email  drsujithkr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  SUJITH K R 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM 
Address  DEPT OF PHYSICAL MEDICINE AND REHABILITATION GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM
KIZHAKKE NANGETH KANJIRAMATTOM ERNAKULAM KERALA
Thiruvananthapuram
KERALA
695011
India 
Phone  9995345242  
Fax    
Email  drsujithkr@yahoo.com  
 
Source of Monetary or Material Support  
SUJITH K R 
 
Primary Sponsor  
Name  SUJITH K R 
Address  JUNIOR RESIDENT DEPT OF PHYSICAL MEDICINE AND REHABILITATION GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM 
Type of Sponsor  Other [investigator himself] 
 
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 Sreedevi MenoP  DEPT OF PMR  MEDICAL COLLEGE THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA 		 9947412900

devisreemukumd@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITEE,GOVT MEDICAL COLLEGE THIRUVANANTHAPURAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  MECHANICAL LOW BACK PAIN,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL SUPERVISED PHYSIOTHERAPY  1. For patients having lumbosacral angle of 30o , spinal flexion based exercises . 2. For patients having lumbosacral angle of 30o , spinal extension based exercises. 3. For patients with positive prone instability test, core muscle stabilization added. 4. For patients with hamstring tightness, hamstring stretching added.  
Intervention  HOME BASED SELF ADMINISTERED EXERCISE PROGRAM  1. For patients having lumbosacral angle of 30o , spinal flexion based exercises . 2. For patients having lumbosacral angle of 30o , spinal extension based exercises. 3. For patients with positive prone instability test, core muscle stabilization added. 4. For patients with hamstring tightness, hamstring stretching added.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Males and females of age group 20-40
2. Patients whose back pain is brought about by mechanical cause , such as segmental instability, or postural habits
3. Patients having chronic back pain of more than 3 months duration
 
 
ExclusionCriteria 
Details  1. Acute and sub acute low back pain of less than 3 months duration
2. Clinical symptoms and signs of nerve root compression
3. History of trauma, cancers, spinal surgeries, cardiac diease,liver and renal disease
4. History of neurogenic claudication
5. Positive Waddells sign-
Inappropriate tenderness
Pain on simulation tests
Inconsistent performance
Regional deficits
Overreaction
6. Cognitive defects preventing adequate understanding of the study.
7. Patients with IUCDs, Pelvic inflammatory disease, DUB, pregnancy

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PAIN,FUNCTIONAL STATUS  12 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
GENERAL HEALTH STATUS  12 WEEKS 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   20/10/2011 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   THIS STUDY IS A RANDOMISED CONTROLLED INTERVENTIONAL TRIAL,COMPARING THE EFFECTIVENESS OF A  HOME BASED SELF ADMINISTERED EXERCISE PROGRAM WITH THAT OF CONVENTIONAL SUPERVISED PHYSIOTHERAPY IN THE TREATMENT OF CHRONIC MECHANICAL BACKACHE . STUDY PERIOD IS 3 MONTHS . OUTCOME MEASURES USEDE ARE  VISUAL ANALOGUE SCALE, OSWESTRY DISABILITY QUESTIONNAIRE , ROLLAND MORRIS LOW BACK  QUESTIONNAIRE AND  SF-36.  
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