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CTRI Number  CTRI/2024/04/066349 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effects of strengthening exercises on low back pain 
Scientific Title of Study   Efficacy of Strength Training on Lumbar Lordosis in Patients with Lower Cross Syndrome  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha 
Designation  Student  
Affiliation  Guru jambheshwar University of science and technology hisar 
Address  Department of Physiotherapy Guru jambheshwar University of science and technology HISAR

Hisar
HARYANA
125001
India 
Phone  8708911255  
Fax    
Email  kushnisha01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonu Punia 
Designation  Assistant Professor  
Affiliation  Guru jambheshwar University of science and technology HISAR  
Address  Department of Physiotherapy Guru jambheshwar University of science and technology HISAR

Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonu Punia 
Designation  Assistant Professor  
Affiliation  Guru jambheshwar University of science and technology HISAR  
Address  Department of Physiotherapy Guru jambheshwar University of science and technology HISAR

Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Source of Monetary or Material Support  
Nisha BPT student Department of Physiotherapy Guru Jambheshwar University of Science and Technology ,Hisar Haryana, 125001 
 
Primary Sponsor  
Name  Department of Physiotherapy  
Address  Guru jambheshwar University of science and technology Hisar Haryana 125001 
Type of Sponsor  Research institution 
 
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 
Nisha  Health centre care Guru jambheshwar University of science and technology HISAR Haryana   Department of Physiotherapy Room no 05 OPD (out patient department)
Hisar
HARYANA 		 8708911255

kushnisha01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee Department of Physiotherapy Guru Jambheshwar University of Science and technology Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M404||Postural lordosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients in this group will perform PNF strengthening exercises for three sessions per week for three weeks. 
Intervention  Strength training on lumbar Lordosis with lower cross syndrome   Patients in this group will perform strengthening exercises for three sessions per week for three weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients who diagnosed with lower cross syndrome.
Those who have been given consent for participating in this study.
Non specific back pain since six months.
Lordosis angle with inclinometer application.  
 
ExclusionCriteria 
Details  History of spinal trauma, joint dysfunction in past three months.
Congenital deformity at hip or lumbar region.
Dislocation of related joint.
Rigidity of the paraspinal muscle.
Any neurological diseases that effects lumbar spine and hip joint.
Rheumatoid arthritis at related joint. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Manual muscle testing(MMT)
Electromyography(EMG)
Numeric pain rating scale(NPRS) 		 The outcome will be assessed for two times which is at baseline and after the three weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Inclinometer to measure lordosis curve  The outcome will be assessed for two times which is at baseline and after the three weeks. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   07/05/2024 
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="0"
Days="28" 
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   It is randomized controlled trial with a duration of three weeks and involving forty patients that will be divided into two groups based on the random method. It’s intervention involves strengthening exercises in one group and PNF exercises in second group. The patient will be informed about the study and written consent will be taken.Firstly each patients demographic information including age, height and weight will be gathered as a baseline data. Pre intervention measurements of outcome measures including inclinometer, MMT, EMG, NPRS at lower back will be taken. Interventions will be given for three weeks then post intervention data of all outcome measures will taken. 
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