| CTRI Number |
CTRI/2026/04/107955 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between pain, psychological, social factors, and disability in individuals with long term low back pain |
|
Scientific Title of Study
|
Relationship of Biopsychosocial Factors and Disability in Patients with Chronic Low Back Pain:
A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Mane |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Kasturba Medical College Department of Physiotherapy Centre of Basic Life Sciences Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8390349882 |
| Fax |
|
| Email |
shreya5.kmcmlr2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
MPT, Ph.D. , Professor |
| Affiliation |
Kasturba Medical College Mangalore, MAHE |
| Address |
Department of Physiotherapy Centre of Basic Life Sciences Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Mane |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Kasturba Medical College Department of Physiotherapy Centre of Basic Life Sciences Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
shreya5.kmcmlr2025@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy Kasturba Medical College Mangalore 575004 Karnataka India |
| 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 |
| Dr Shreya Mane PT |
Kasturba Medical College Hospital Attavar |
Department of Physiotherapy 2nd Floor Kasturba Medical College Hospital Attavar Mangalore 575001 Dakshina Kannada
Dakshina Kannada
KARNATAKA |
8390349882
shreya5.kmcmlr2025@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M545||Low back pain, |
|
|
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 |
1) Adults with Chronic Low back pain (pain present for more than 12 weeks) referred to physiotherapy.
2) Able to sit, stand and walk independently. |
|
| ExclusionCriteria |
| Details |
1) Pregnancy
2) LBP with a specific diagnosis (history of disc prolapse, vertebral fracture, Ankylosing spondylitis, etc), serious spinal pathology like cancer, cauda equina lesion, or any radicular symptoms indicative of nerve root compression, severe stenosis or spondylolisthesis
3) Systemic inflammatory disorders such as SLE, Rheumatoid arthritis, etc.
4) History of spinal surgery
5) Patients diagnosed with Depression and Anxiety |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Roland-Morris Disability Questionnaire (RMDQ), Pain Catastrophizing Scale (PCS), PHQ-4 |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Kuppuswamy Scale, NPRS |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
27/04/2026 |
| 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="0"
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
|
The study aims to evaluate and identify the association of pain, psychological factors and socioeconomic status with disability caused by chronic low back pain. Furthermore, it aims to assess the relationship between psychological factors and sociodemographic variables of patients with chronic low back pain. Participants within 18 to 65 years of age who fulfil the inclusion criteria will be recruited. Biopsychosocial factors will be assessed with the help of NPRS, Pain catastrophizing Scale, PHQ-4, and Modified Kuppuswamy scale. Disability will be assessed with Roland-Morris Disability Questionnaire.. Data will further be subjected to statistical analysis. |