| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kiyakaanchi.36@gmail.com].
- 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.
- 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. |