| CTRI Number |
CTRI/2024/08/071991 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Find Out Prevalence of Calf Muscle Pain in Healthcare Workers |
|
Scientific Title of Study
|
Prevalence of Calf Muscle Pain Among Health Care Professionals: 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 |
Sijal Sood |
| Designation |
BPT Undergraduate student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital,Department of Physiotherapy, Room No. 510 Kumarhatti Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876854496 |
| Fax |
|
| Email |
sijalsood9066@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room No. 510 Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7807125689 |
| Fax |
|
| Email |
tomarankit084@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital kumarhatti Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy,Room No. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital Department of Physiotherapy, Room No. 510, Kumarhatti, Solan Solan, Pincode-173229, Himachal Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Sijal Sood |
| Address |
Village Ambawri V.P.O Malan tehsil Nagrota Bagwan district kangra, Pincode 176047 Himachal Pradesh, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Sijal Sood |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Room No. 510, Kumarhatti Solan
Solan
HIMACHAL PRADESH |
7876854496
sijalsood9066@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maharishi Markandeshwar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Calf Muscle Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 20-40 years
2.Healthcare professionals
3.Work experience more than 1 year
4.History of calf muscle pain for more than one month |
|
| ExclusionCriteria |
| Details |
1.History of any neurological and rheumatic disease
2.History of knee surgery
3.History of musculoskeletal disorder (fracture, DVT, malignancy, various vein, open wound in the calf)
4.History of taking physical therapy in lasts 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self-Administered Calf Evaluation Questionnaire |
At Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="295"
Sample Size from India="295"
Final Enrollment numbers achieved (Total)= "295"
Final Enrollment numbers achieved (India)="295" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2024 |
| Date of Study Completion (India) |
10/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/11/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Self- Administered Calf Evaluation Questionnaire
This questionnaire is made for the calf muscle pain evaluation and symptoms which are related to
work acquired job (standing job). The produced items for the Self-Administered Calf Evaluation
Questionnaire for health care professionals is being utilized for literature review about calf muscle
pain among healthcare professionals. The question comprises of pain, discomfort, severity,
aggravation, etc. Each question was evaluated by group of 15 expert professionals. A google form
link was sent to the panel of expert via an email. The opinion and suggestions of the expert was
taken, and modifications were made according to their suggestions. The participants (295) will be asked to voluntarily participate in the research process after being
informed about the study. A written consent will be provided to each participant and signed it
accordingly. After that Self -Administered Calf Evaluation Questionnaire will be provided to the
participants in the form of hardcopy. Questionnaire will be explained to the participants and
requested to complete the questionnaire. The information gathered from the questionnaire will be
analyzed to draw conclusion relevant to the objectives of the research. |