| CTRI Number |
CTRI/2025/02/080231 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of muscle mass and abdominal fat on movement and daily activities in people with chronic low back pain |
|
Scientific Title of Study
|
Relationship between skeletal muscle mass, abdominal obesity parameters and disability in 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 |
Ayyappan S |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai-600116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9698363699 |
| Fax |
|
| Email |
ayyappan2161@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Antony Leo Aseer P |
| Designation |
Professor and Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai-600116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9841544303 |
| Fax |
|
| Email |
antonyleo@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Antony Leo Aseer P |
| Designation |
Professor and Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai-600116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9841544303 |
| Fax |
|
| Email |
antonyleo@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennar - 600 116 Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennar - 600 116 Tamil Nadu |
| 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 |
| Ayyappan S |
Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research |
Physical Rehabilitation Department, Ground Floor, New Block OPD, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennar - 600 116 Tamil Nadu
Chennai
TAMIL NADU |
9698363699
ayyappan2161@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with chronic low back pain |
|
| ExclusionCriteria |
| Details |
Recent surgery or trauma
Systemic inflammatory diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Appendicular skeletal muscle mass index, axial skeletal muscle mass, visceral fat area, subcutaneous fat area |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Roland Morris Disability Questionnaire, Pain Intensity, Range of Motion, Muscle endurance, Physical performance test |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study adopts a cross-sectional design to investigate the associations between Appendicular Skeletal Muscle Mass Index (ASMI), Axial Skeletal Muscle Mass (AxSM), abdominal obesity parameters (visceral and subcutaneous fat areas), and disability in individuals with Chronic Low Back Pain (CLBP) compared to healthy controls. Participants with the CLBP group comprising adults aged 18–65 diagnosed with CLBP persisting for more than 3 months, while healthy controls will be matched for age, sex, and BMI, with no history of back pain. Exclusion criteria include the presence of other spinal pathologies, systemic conditions, recent surgeries, or pregnancy. A body composition analyzer will be used to measure ASMI, AxSM, and abdominal fat areas, while the Roland-Morris Disability Questionnaire (RMDQ) will assess disability. Statistical analysis will examine these variables, including gender-specific differences and comparisons between sarcopenic and non-sarcopenic individuals within the CLBP group. The study will adhere to ethical standards, securing informed consent from all participants and ensuring confidentiality throughout. |