| CTRI Number |
CTRI/2024/07/071201 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Abdominal Muscle Strength And Foot Strength In Housekeeping Staff With and Without Low Back Pain. |
|
Scientific Title of Study
|
Comparison Of Core Muscle Strength And Foot Strength In Housekeeping Staff With And Without Non-Specific 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 |
| Designation |
1st year MPT-Musculoskeletal Sciences |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No 10 Father Muller Road,
Kankanady,
Mangalore-575002,
Karnataka, INDIA
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7483977599 |
| Fax |
|
| Email |
shreyajnvu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms .P Chaitra Bhat |
| Designation |
Assistant Professor - Musculoskeletal Sciences |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College, Father Muller Road,
Kankanady,
Mangalore-575002,
Karnataka, INDIA
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8904760245 |
| Fax |
|
| Email |
chaitraphysio07@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Shreya |
| Designation |
1st year MPT-Musculoskeletal Sciences |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College Hospital, Department of Physiotherapy, Physiotherapy Opd Room no 10,Father Muller Road,
Kankanady,
Mangalore-575002,
Karnataka, INDIA
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7483977599 |
| Fax |
|
| Email |
shreyajnvu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital, Department Of Physiotherapy , Physiotherapy Opd Room no 10, Father Muller Road,Kankanady 577002
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Self Sponsor |
| Address |
Father Muller Medical College, Father Muller Road,
Kankanady,
Mangalore-575002,
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 |
Father Muller College of Physiotherapy |
Father Muller Medical College Hospital, Department Of Physiotherapy, Physiotherapy Opd Room no 10, Father Muller Road.
Kankanady,
Mangalore-575002,
Karnataka, INDIA
Dakshina Kannada
KARNATAKA |
7483977599
shreyajnvu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Committiee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-specific low back pain with and without |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Housekeeping staff with and without pain in the lower back.
Kannada Oswestry Disability Index score range from 1-34 (screening tool)
Non-specific low back pain that is localized to the lumbosacral region, affects the L1-L5 spine and the sacroiliac joints and lasts at least 4 weeks in the case of acute pain, 4-12 weeks in the case of subacute pain, and more than 12 weeks in the case of chronic pain.
Workers who have at least 1 year of experience in housekeeping department with the duration of work 7-8 hours. |
|
| ExclusionCriteria |
| Details |
Individuals with clinically diagnosed musculoskeletal disorders with involvement of a pathology involvement (Eg; tumour, osteoporosis, infection, fracture, structural deformity, inflammatory disease, radicular or cauda equina syndrome).
Neurological disorders that affect lower back and foot.
Housekeeping staff with congenital spinal deformities.
Pregnancy and postpartum(<6months).
Individual with recent lumbar, abdominal and gynaecological surgeries in the past year.
Those who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Core muscle strength using Pressure Biofeedback Unit |
Starting after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot strength using Hand-Held Dynamometer |
Taking after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/08/2024 |
| 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
|
Individuals of all ages experience non-specific low back pain, which is a major global contributor to the burden of disease. There is no recognized pathoanatomical cause for non-specific low back pain. Approximately 90% of low back pain diagnoses are non-specific (i.e. with unknown cause). Housekeepers who perform repetitive movements like bending, lifting and prolonged standing are more prone to back pain and foot pain.  In order to develop spinal stability and a stronger foundation for strength in lower extremity movement, investigation on core muscle function are crucial for understanding musculoskeletal risk factors linked to persistent low back pain associated with occupational group and stress of lifting objects.
The strength of the foot muscles may be crucial for clinical diagnostic and therapeutic purposes. Many other types of foot abnormalities and foot discomfort are also linked to weakening of the foot muscles. There are lack of studies of non-specific low back pain on core muscle strength and foot strength in housekeeping staff, who have unique job requirements and ergonomic challenge. |