FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064121 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between pain tolerance and maximum strength for 1 repitation for participant predicted and therapist estimated 
Scientific Title of Study   Correlation of Pain Tolerance with Participant Predicated VS Therapist Estimated One RM in Normal Individuals  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharati D Asgaonkar  
Designation  Associate Professor  
Affiliation  Associate Professor  
Address  OPD number 24 ,Room number 2 ,M building,PT School and Centre,Topiwala National Medical College, Mumbai Central

Mumbai
MAHARASHTRA
400008
India 
Phone  9987103028  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bharati D Asgaonkar  
Designation  Associate Professor  
Affiliation  Associate Professor  
Address  PT School and Centre,Topiwala National Medical College, Mumbai Central

Mumbai
MAHARASHTRA
400008
India 
Phone  9987103028  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bharati D Asgaonkar  
Designation  Associate Professor  
Affiliation  Associate Professor  
Address  PT School and Centre,Topiwala National Medical College, Mumbai Central

Mumbai
MAHARASHTRA
400008
India 
Phone  9987103028  
Fax    
Email  bharatida1234@gmail.com  
 
Source of Monetary or Material Support  
OPD number 24, Room no 2, N building, PT School and Centre, Topiwala National Medical College, Mumbai Central  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
DrJaskeeratkour Batra  Topiwala National Medical College & Bai Yamunabai Laxman Nair Ch Hospital  OPD-24,PT School & Centre , Topiwala National Medical College and B.Y.L Nair Ch Charitable Hospital, dr.A.L Nair Road ,Mumbai Central ,Mumbai -400008 ,Mumbai, MAHARASTRA
Mumbai
MAHARASHTRA 
9834935136

jaskiratbatra684@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18 TO 60 YEAR OF AGE NO CO MORBIDITIES LIKE DIABETES OR SKIN CONDITIONS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.18 to 60 Years of Individual
2.Both Genders
3.Individuals with Normal Superficial Sensations like Touch ,Pain, Temparature at the forearm region 
 
ExclusionCriteria 
Details  1.Individuals with Co morbidities like Diabetes
2.Individuals with Dermatological Condition
3.Individuals with Neurological Condition
4.Injuries or lesions around knee 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Intensity of Galvanic Current
2.Hand Held Dynamometer  
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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)   25/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
There are lack of evidences regarding correlation of pain tolerance and strength in the Population. In previous studies pain threshold was measured by providing heat using Medoc Thermal Sensory Analyzer ,Pressure Algometer or Autoalgometer, Ice Cold Cylinder, but as it is not available in our OPD we prefer using Galvanic Current for its availability . In this study pain tolerance will be checked using galvanic current
As 1 RM is very important entity in exercise program we want to find if it is correlated with pain tolerance 
Aim of our study is to check whether individual who have less pain tolerance assume that they have less strength or Is there any correlation or discrepancy between participant predicted and therapist estimated 1RM.
 The implications and therapeutic applications of these findings are significant and wide ranging if laboratory  based measurement of individual differences in pain sensitivity can prospectively predict individual differences in acute clinical pain, chronic pain and pain medication response.
In multiple papers and reviews, recent research has highlighted the potential therapeutic uses of experimental pain assessment (e.g., for predicting post-operative pain, therapy response, etc.). These papers and reviews have used quantitative sensory testing to quantify pain sensitivity.
Quantitative sensory assessments of pain sensitivity aren’t used very often because of the time, money, and expertise requirements, not to mention their costs. So, the purpose of this study is to determine whether self-reporting can be a valid indicator of a person’s pain threshold and patient anticipated 1 RM.
 
Close