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CTRI Number  CTRI/2025/11/097498 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 16/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pain characteristics in individuals with history of low back pain 
Scientific Title of Study   Temporal Summation in asymptomatic individuals with a history of low back pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaanchi Patel 
Designation  Student 
Affiliation  Manipal College of Health Professions 
Address  Department of physiotherapy, Manipal College of Health Professions, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09555956599  
Fax    
Email  kiyakaanchi.36@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Radhika Aditya Jadhav 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of physiotherapy, Manipal College of Health Professions, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7829500469  
Fax    
Email  radhika.aj@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Anupama Prabhu B 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of physiotherapy, Manipal College of Health Professions, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986451010  
Fax    
Email  anupama.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions (MCHP), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Manipal College of Health Professions MCHP 
Address  Manipal College of Health Professions (MCHP), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Private medical college 
 
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 
DrKaanchi Patel  Kasturba Hospital  Room no.301, Department of Physiotherapy,Kasturba hospital, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9555956599

kiyakaanchi.36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  People with previous history of resolved low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Individuals with a history of low back pain within the last 2 years who have been asymptomatic for the last 3 months 
 
ExclusionCriteria 
Details  • Any ongoing pain
• Spinal tumours
• Infection
• Trauma or fracture
• Spinal deformities
• Acute injury or recent spinal surgeries
• Currently using pain medications such as opioids, analgesics, and sedatives 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the variation in temporal summation of pain in asymptomatic individuals with a history of low back pain.  One time point 
 
Secondary Outcome  
Outcome  TimePoints 
To examine the relationship between fear-avoidance beliefs & temporal summation in individuals with a history of low back pain.  One time point 
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
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)   11/11/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kiyakaanchi.36@gmail.com].

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

According to recent research, young Indian individuals are more likely than their Western counterparts to experience low back pain (LBP). Low back pain develops and persists due to both psychological and physical factors. Psychological factors can intensify or prolong pain experiences, such as fear-avoidance attitudes, which cause people to avoid movement or activity out of fear of pain. The processing and maintenance of pain are significantly influenced by physiological processes such as Central Sensitization, in which the nervous system becomes more sensitive to pain, and altered pain modulation.

The fact that not all healthy individuals exhibit temporal summation (TS) of pain—a condition in which repeated stimulation heightens pain perception—is another important observation. This variation occurs irrespective of the stimulus type. where it is administered on the body or how long it lasts. This implies that there can be significant differences in how each person processes pain, which could affect how pain is experienced as well as how well remedies work.

Knowing how temporal summation varies after LBP goes away may help explain why some people are more likely to experience pain episodes again. Certain pain processing patterns may be the focus of prevention or intervention if they continue to exist even after symptoms have subsided.

Additionally, researching temporal summation in individuals who are pain-free but have recovered from LBP may aid in the creation of individualized management plans. For those with a history of LBP, this tailored strategy may lower the chance of recurrent episodes and enhance long-term results.

 
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