| CTRI Number |
CTRI/2025/12/099429 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comprehensive Functional and Psychological Assessment Scale for Patients with Chronic Low Back Pain: Development, Validation and Psychometric Testing |
|
Scientific Title of Study
|
Development, Validation, Reliability And Psychometric Testing Of Comprehensive Functional And Psychological Assessment Scale 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 |
Aditi Popli |
| Designation |
Phd Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 5, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
133207
India |
| Phone |
09896461613 |
| Fax |
|
| Email |
aditi.popli.freebird@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 5, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Popli |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No.5, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
132001
India |
| Phone |
09896461613 |
| Fax |
|
| Email |
aditi.popli.freebird@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Mullana, Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aditi Popli PT |
Maharishi Markandeshwar institute of physiotherapy and rehabilitation |
Room No. 5 Physiotherapy Department, MMIPR, MM(DU), Mullana
Ambala
HARYANA |
09896461613
aditi.popli.freebird@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with chronic mechanical low back pain.
2. Duration of low back pain: minimum of 6 months.
3. Age between 20-60 years.
4. Both male and female.
5. BMI as per Asian Classification
6. Pain more than 5 on NPRS.
|
|
| ExclusionCriteria |
| Details |
Patients having low back pain less than 6 months duration.
2. History of spinal surgery in last 1 year
4. Patients with definite neurodeficit will be excluded.
5. Pregnant females.
6. Spinal injection, fracture, malignancy, spondylolisthesis, PIVD.
7. Not willing to participate.
8. Inflammatory Arthritis.
9. patients with psychosomatic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive Functional and Psychological Assessment |
Baseline and after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
31/12/2025 |
| 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
|
Background: Low Back Pain (LBP) ranks as one of the most
prevalent musculoskeletal conditions around the world. The average lifetime
prevalence of LBP in Northern-India was reported to be 57%, with women
(65%) having a significantly greater prevalence than men (47%). There is limited literature available on assessing the combined impact
on functional disability and psychological status in patients
with chronic LBP patients in Northern India. The aim
of the study is to validate and test all the psychometric properties of Comprehensive Assessment scale for patients
with chronic LBP in northern India.
Study
Design: A cross-sectional study Methods: The study will be conducted in 3 phases: 1) development phase,
2) validation phase, 3) testing psychometric properties. For the formation of
domains and framing a pre-final draft for the scale development, 7-8 patients
having chronic LBP from the past year will be interviewed, followed by related
literature searches and expert panel opinions. The draft will be
validated in terms of content validity via the Delphi survey method, construct
validity via confirmatory factor analysis, and concurrent validity will be analysed
by correlating the comprehensive assessment scale with other valid questionnaire.
The data will be collected from patients to test the final draft of the
comprehensive assessment scale for its psychometric properties.
Statistical analysis will be done using IBM SPSS software (version 26). The
data collected from the patients will be analysed for its absolute and relative
reliability and other psychometric properties like sensitivity,
specificity, Small-Worthwhile Change, Minimal Detectable Change, Standard Error
Mean and Coefficient of Variation. |