| CTRI Number |
CTRI/2026/02/104272 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship between increased pain sensitivity and mental health factors in people with long-term low back pain |
|
Scientific Title of Study
|
Correlation of Central Sensitisation with Psychological Constructs in patients with Chronic 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 |
Anubhav Majumdar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of PMR , AIIMS Guwahati , Changsari , Assam
Kamrup
ASSAM
781101
India |
| Phone |
9862476466 |
| Fax |
|
| Email |
anubhavmajum07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of PMR, AIIMS Guwahati , Changsari , Assam
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
drsatya.1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anubhav Majumdar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of PMR , AIIMS Guwahati , Changsari , Assam
Kamrup
ASSAM
781101
India |
| Phone |
9862476466 |
| Fax |
|
| Email |
anubhavmajum07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Guwahati |
| Address |
Changsari , Kamrup , Assam - 781101 |
| Type of Sponsor |
Government 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 |
| Dr Anubhav Majumdar |
AIIMS Guwahati |
Room no 1075 , Department of PMR , AIIMS Guwahati
Kamrup
ASSAM |
9862476466
anubhavmajum07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M488||Other specified spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Patients with low back pain for more than 3 months
•Patients aged 18 years to 65 years
|
|
| ExclusionCriteria |
| Details |
1.Patients with low back pain due to infection, malignancy, injury, fracture, or inflammatory spondyloarthropathy.
2.Those with severe psychiatric illness or cognitive impairment that may interfere with questionnaire response.
3.Neurological disorders affecting sensory testing (e.g., peripheral neuropathy, stroke, spinal cord injury).
4.Patients currently on medications significantly influencing sensory perception (e.g. : opioids, sedatives , antidepressants etc).
5.Pregnancy
6.Systemic comorbidities like Diabetes Mellitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to provide insights into the relationship between central sensitisation and psychological factors in chronic low back pain.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
15/03/2026 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
Chronic low back pain is a common condition where pain continues for more than 3 months and may not be explained only by local tissue problems. In many patients, the nervous system becomes overly sensitive and amplifies pain signals, a process called central sensitisation. Psychological factors such as depression, anxiety, and somatic symptom burden may further influence pain severity and disability. This hospital-based cross-sectional study will be conducted at AIIMS Guwahati among adults aged 18–65 years with chronic low back pain. Central sensitisation will be assessed using the Central Sensitisation Inventory (CSI) and Thermal Quantitative Sensory Testing (QST) including Warm Detection Threshold, Warm Pain Threshold, and Conditioned Pain Modulation. Psychological constructs will be evaluated using HAM-D, HAM-A, and SSS-8. Correlation between central sensitisation measures and psychological scores will be analysed using appropriate statistical methods. The study aims to identify the association between altered pain processing and psychological health in chronic low back pain, which may help in improving patient profiling and supporting a more holistic, individualised rehabilitation approach. |