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CTRI Number  CTRI/2023/11/059709 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 08/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   The movement controlling exercises, and gentle stretches exercises given to reduce pain and lordosis angle and in patients with nonspecific low back pain.  
Scientific Title of Study   Kinetic control V/S Egoscue exercises on correction of hyperlordosis, pain, disability in individuals with nonspecific low back pain: A randomized clinical trail  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  APOORVA BIRADAR 
Designation  PG student 
Affiliation  KAHER institute of physiotherapy 
Address  Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka India
Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka India
Belgaum
KARNATAKA
590010
India 
Phone  08618154966  
Fax    
Email  apoorvab623@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijay Kage 
Designation  Professor and Head of department of orthopedic physiotherapy  
Affiliation  KAHER institute of physiotherapy 
Address  Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka india
Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka india
Belgaum
KARNATAKA
590010
India 
Phone  09845271899  
Fax    
Email  vijaykage@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Vijay Kage 
Designation  Professor and Head of department of orthopedic physiotherapy  
Affiliation  KAHER institute of physiotherapy 
Address  Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital Belgaum Karnataka 590010 Belgaum Karnataka India
Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital Belgaum Karnataka 590010 Belgaum Karnataka India
Belgaum
KARNATAKA
590010
India 
Phone  09845271899  
Fax    
Email  vijaykage@yahoo.in  
 
Source of Monetary or Material Support  
KLES DR PRABHAKAR KORE HOSPITAL AND RESEARCH CENTRE BELAGAVI Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka India 
 
Primary Sponsor  
Name  KLE academy of higher education and research 
Address  Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital belgaum karnataka 590010 Belgaum Karnataka India 
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 apoorva biradar  kle prabhakar kore hospital  Advanced physiotherapy center, room no 39,sagar floor, KLE Dr Prabhakar kore hospital Belgaum Karnataka 590010 Belgaum Karnataka India
Belgaum
KARNATAKA 		 08618154966

apoorvab623@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kle academy of higher education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  kinetic control exercises and convention treatment.  kinetic control exercises and convention treatment will be given for for 3 sessions per week over a period of 4 weeks.  
Comparator Agent  kinetic v/s egoscue exercises  the intervention will be 3 session per week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Participants with Age group between 18-50 years both male and female
2.Participants screened and diagnosed with low back pain and lumbar hyperlodosis
3.Anterior pelvic tilt angle of >13°
4.Willing to participate in the study
 
 
ExclusionCriteria 
Details  1.Subjects with a history or current status of spinal fracture
2.who had surgical procedures related to spine and with other radicular symptoms
3.Low back pain due to specific conditions like malignancy and trauma.
4.Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
inclinometer and flexi curve.  Anterior pelvic tilt – using the inclinometer and flexi curve. 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)and Oswestry Disability Index (ODI) questionnaire.  Pain Intensity – It was assessed, using the Visual Analogue Scale (VAS)• Disability - using the Oswestry Disability Index (ODI) questionnaire. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   22/11/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  22/11/2023 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

AIM OF THE STUDY:

 

•       To study the effectiveness of kinetic control and Egoscue exercises, for Correction of hyperlordosis, pain, disability in individuals with non-specific low back pain.

INCLUSION CRITERIA:

 

•       Participants with Age group between 18-50 years both male and female

•       Participants screened and diagnosed with low back pain and lumbar hyperlodosis

•       Anterior pelvic tilt angle of >13° and Willing to participate in the study

 

  EXCLUSION CRITERIA:

 

•       Subjects with a history or current status of spinal fracture

•       who had surgical procedures related to spine and with other radicular symptoms

•       Low back pain due to specific conditions like malignancy and trauma.

•       Pregnancy

•       Psychological disorders affecting the subject’s ability to follow the instructions

OUTCOME MEASURES:

  1. PRIMARY OUTCOME MEASURES

•       Anterior pelvic tilt – using the inclinometer.

            Degree of lumbar lordosis- using index of lumbar lordosis A 61 cm Surveyor’s flexi curve will be used

1.     SECONDARY OUTCOME MEASURES

•       Pain Intensity – It was assessed, using the Visual Analogue Scale (VAS)

            Disability -  using the Oswestry Disability Index (ODI) questionnaire

  The study participants will be randomly allocated into two different groups. Group A will be administered with kinetic control exercises and Group B will be administered with egoscue exercises. Both the groups will be given conventional therapy. Post assessment of outcome measures will be done at the end of 4 weeks intervention
 
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