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CTRI Number  CTRI/2023/03/050601 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 13/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   kinesophobia in chronic non specific low back pain 
Scientific Title of Study   Prevalence of kinesophobia and relation with pain characteristics in chronic non-specific 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  Oshmi Pal 
Designation  Post Graduate Student 
Affiliation  SDM college of Physiotherapy 
Address  SDM college of Physiotherapy Manjushree Nagar sattur Dharwad Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  9826029193  
Fax    
Email  oshmi96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Oshmi Pal 
Designation  Post Graduate Student 
Affiliation  SDM college of Physiotherapy 
Address  SDM college of Physiotherapy Manjushree Nagar sattur Dharwad Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  9826029193  
Fax    
Email  oshmi96@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr shweta kulkarni 
Designation  Professor 
Affiliation  SDM college of physiotherapy 
Address  SDM college of physiotherapy OPD no 5 Department of orthopaedics physiotherapy. manjushreenagar sattur Dharwad Karnataka India.

Dharwad
KARNATAKA
580009
India 
Phone  9886276543  
Fax    
Email  dr.shweta07@gmail.com  
 
Source of Monetary or Material Support  
SDM college of physiotherapy orthopaedics department 
 
Primary Sponsor  
Name  Oshmi Pal  
Address  SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India 
Type of Sponsor  Other [self] 
 
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 
Oshmi Pal  SDM college of medical science and hospital  SDM college of physiotherapy OPD no-5 Department of orthopaedics physiotherapy. manjushreenagar sattur Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA 
9826029193

oshmi96@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 
Healthy Human Volunteers  chronic non specific low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with the type of low back pain Chronic (more than 3 months of duration),
Non-specific and Non- radicular diagnosed by orthopaedician.
2. Age group between18-65 years.12.
3. Subjects of either gender
4. Subjects who agree and are ready to sign the consent form 
 
ExclusionCriteria 
Details  1. Subjects with acute low back pain and with a known cause of Radicular pain.
2. Subjects with an age group less than 18 and more than 65 years.12
3. Serious or progressive neurological deficits.
4. Presence of co-existing chronic pain conditions other than low back pain (eg.
Fibromyalgia)
5. Symptoms underlying conditions such as (tumor osteoporosis, spinal canal
stenosis, compression fracture, structural deformities of spine.
inflammations/infectious disease, lumbar radiculopathy, ankylosing spondylosis,
cauda equina syndrome)
6. Sensory loss of skin.
7. Skin inflammation or edema in the lower back
8. Pregnant or until 1 year postnatal
9. Epilepsy, cancer, arthritis (except osteoarthritis), major psychiatric disorders.
10. Awaiting surgery or having had surgery in the past.
11. Individuals not ready to sign the consent form 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
vas scale
tampa scale  
baseline (we are doing subject assessment only once) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain catastrophizing scale
SF 36 questionnaire
Pressure algometer
Self-efficacy scale
Recognize app for back 
baseline (we are doing subject assessment only once) 
 
Target Sample Size   Total Sample Size="262"
Sample Size from India="262" 
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)   16/03/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

According to a few studies, they have commented that the fear of movement (kinesophobia) is one of the determinants of acute pain developing into chronic pain. Another study has concluded that subjects who did not recover in two months developed chronic pain and fear of pain was the most predicting factor of chronic pain. Also, another study mentioned that pain-free subjects when assessed for fear had high chances of developing musculoskeletal pain in the future (vlaeyen) literature also states that among various other psychological factors, kinesophobia is positively associated with pain intensity, disability, in chronic low back pain. But the limitations of these studies were that the sample size was less, the population was heterogeneous and they were not able to find the cause and effect relationship between the pain and other factors as the study was a cross-sectional also studies have stated that objective outcome measures should be used as all of these studies included the self-reported measures and most of these studies were conducted abroad, so the results couldn’t be generalized to all the populations.

 

There exists a strong need to find out the prevalence of strong predictors of chronic pain that as kinesophobia and also to find out the correlation between kinesophobia and characteristics of chronic pain using objective methods like pressure algometer (pain pressure threshold) and laterality test in chronic nonspecific low back pain as it is more prevalent in India (60%). Hence this study aims to find out the prevalence of kinesophobia and relation with pain characteristics in chronic non-specific low back pain. 

 
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