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CTRI Number  CTRI/2019/03/018257 [Registered on: 25/03/2019] Trial Registered Prospectively
Last Modified On: 29/04/2022
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   Pain education and exercises in low back pain 
Scientific Title of Study   Effect of Pain Neuromatrix approach on function in chronic low back pain with central sensitization: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Joshita Jayanarayan Poojary 
Designation  Master of physiotherapy(MPT) student  
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India

Bangalore
KARNATAKA
560017
India 
Phone  8104142521  
Fax    
Email  poojaryjoshita22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Prem V 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
SOAHS, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  SOAHS Manipal Academy of Higher Education  
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore 
Type of Sponsor  Research institution and hospital 
 
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 
Joshita Jayanarayan Poojary  Manipal Hospital  Outpatient Physiotherapy Department, Upper Basement, #98 Rustum Bagh, Old airport road, Bangalore
Bangalore
KARNATAKA 		 8104142521

poojaryjoshita22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional rehabilitation for chronic low back pain  12 weeks of supervised rehabilitation with total 15-18 session in 3 phases each session will last for 45 minutes to one hour. In Phase 1(0-4 weeks,4-6 session ):The treatment will be focusing on general education consisting of ergonomic advice such as lifting techniques,posture correction advises and activation of local and global stabilizers of spine In Phase 2 (5-8 weeks,4-5 sessions):stretching and strengthening exercises such as cat and camel,pelvic tilt,and spine extension exercises In phase 3 (8-12 weeks, 4-6 session):functional exercise program such as deep squatting,single leg squatting ,lateral lunge  
Intervention  PAIN NEUROMATRIX APPROACH  12 weeks of supervised rehabilitation with total 15- 18 session in 3 phases each session will last for 45 minutes to one hour. In Phase 1(0-4 weeks,4-6 sessions): The treatment will be focusing on reducing the threatening input(nociceptive mechanism) that will consist of neurophysiological education and exercises, neurophysiological pain education will be given using educational tools such as, prepared pictures, examples, hand drawing, work book, power point presentations which will mainly emphasize on neurophysiology of pain, nociception and nociceptive pathways, neurons, synapses,action potential, spinal inhibition and facilitation,central sensitization, plasticity of nervous system.identifying posture and movement causing pain In Phase 2 (5-8 weeks,4-6 sessions):treatment will be focusing on reducing the threatening input (non-nociceptive mechanism) that will consist of cognition-targeted neuromuscular training,time contingent training coordinated activities of spinal muscles such as quadruped arm/leg exercise progression to pain free exercise. In Phase-3(8-12 weeks,4-6 sessions):focused on activation of components of the individual pain neuromatrix that will consist of increasing the complexity of exercise of functional task such as planks,side planks. progression towards those movements which the patient is fearful such as sitting for long hours depending on the tolerance/requirement of the patient progression to exercise during cognitively and psychological stressful conditions such as exercise with eyes open,eyes close,perturbations.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Low back pain >12 weeks
Patients positive for central sensitization using two-point discrimination device vernier caliper
Patients positive for central sensitization using quantitative sensory testing  
 
ExclusionCriteria 
Details  Lumbar Radiculopathy and Myelopathy
Spinal disorders such as Spinal stenosis, malignancy, infection,Fracture
Spinal fusion spine surgeries
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oswestry Low Back Pain Disability Questionnaire,two-point discrimination using Vernier caliper
 		 Baseline
At the end of 4th week and 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale  Baseline
At the end of 4th and 12th week 
Quantitative Sensory Testing  Baseline
At the end of 4th and 12th week 
Central sensitization inventory   Baseline
At the end of 4th week and 12 the week  
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2019 
Date of Study Completion (India) 23/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Low back pain is defined as pain and /or discomfort localized below the costal margin and above gluteal fold with possible radiation to posterior thigh not extending below the knee and is defined as chronic low back pain when it persists for 12 weeks or more, Chronicity of low back pain increases causing delayed recovery of pain a high disability or pain levels, low levels of education and higher perceived risk of persistant pain,Growing evidence supports the clinical importance of central sensitization in patients with chronic musculosketal pain often characterized by brain plasticity that leads to hyperexcitiblity of central nervous system. Potential desensitizing treatment for chronic low back pain has not been adequately addressed,evidence that pain Neuromatrix approach may be an effective sole treatment in chronic low back pain, as the approach systematically determine factors associated wit the persistent pain state and work on stratergies to disengage those adjacent maps along with manual therapy intervention in treating central sensitization. 
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