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CTRI Number  CTRI/2020/04/024790 [Registered on: 22/04/2020] Trial Registered Prospectively
Last Modified On: 14/04/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Beliefs about pain in long term joint, muscle pain  
Scientific Title of Study   Pain related beliefs in patients with chronic musculoskeletal pain  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Y V Raghava Neelapala PT MPT 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yuvaraghava999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Y V Raghava Neelapala 
Designation  Assistant Professor  
Affiliation  Department of PManipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yuvaraghava999@gmail.com  
 
Details of Contact Person
Public Query  
Name  Y V Raghava Neelapala 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yuvaraghava999@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka. 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
Y V Raghava Neelapala  N1 block, Deparment of Physiotherapy, Kasturba Hospital   Department of Physiotherapy, Kasturba Hospital, Manipal, Karnataka
Udupi
KARNATAKA 		 9482773219

yuvaraghava999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee, Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with chronic musculoskeletal pain
•(spinal pain, fibromyalgia, knee pain, shoulder pain)
• Pain intensity >3/10 (NPRS) since the last 3 months
• Age group: 20 to 50 years. 
 
ExclusionCriteria 
Details  Patients with whom communication is difficult.
Non musculoskeletal causes of chronic pain.
Patients unwilling to participate in the study 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Pain related beliefs questionare  One time measurement at the time of recruitment - cross sectional study 
 
Secondary Outcome  
Outcome  TimePoints 
None   None 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   27/04/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Pain related beliefs have been found to influence the recovery, and it is essential to assess the beliefs of patients with chronic musculoskeletal pain. Pain related beliefs such as pain catastrophising, fear avoidance, and self efficacy are some of the psychological factors that contribute to chronicity of pain. However, no studies have been found on pain related beliefs among the Indian population. Therefore, the aim of the study is to capture pain related beliefs in patients with chronic musculoskeletal pain in Indian population using a preliminary questionnare.
The Instiutional Ethics committe has approved and the study will be conducted on patients with chronic musculoskeletal pain (spinal pain, fibromyalgia, knee pain, shoulder pain), pain intensity >3/10 (NPRS) since the last 3 months and in the age group: 20 to 50 years.Patients with whom communication is difficult and the non musculoskeletal causes of chronic pain and patients unwilling to participate in the study.
A preliminary questionnaire will be developed and face validated by subject experts inclusive of components such as pain catastrophising, fear avoidance and self efficacy.  The participants will be screened based on the inclusion and exclusion criteria and a written informed consent will be obtained from the selected participants. The developed and validated pain belief questionnaire will be administered to the included participants. Responses will be obtained based on the questionnaire and results will be reported using descriptive analysis.
 
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