| 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
|
|
|
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
|
|
|
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. |