| CTRI Number |
CTRI/2021/06/034034 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
PREVALENCE AND RISK FACTORS OF PLANTAR FASCIITIS IN NURSES. |
|
Scientific Title of Study
|
PREVALENCE AND RISK FACTORS OF PLANTAR FASCIITIS IN NURSES: A CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Shanbhag |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
09765277877 |
| Fax |
|
| Email |
shivanishanbhag96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJEEV LAL |
| Designation |
PROFESSOR AND PG GUIDE |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
996202056 |
| Fax |
|
| Email |
lalrk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Shanbhag |
| Designation |
Post Graduate Student |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
09765277877 |
| Fax |
|
| Email |
shivanishanbhag96@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Shivani Shanbhag |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR
SATTUR
DHARWAD
580009 |
| 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 |
| Shivanishanbhag |
Shri Dharmasthala Manjunatheshwara College of Medical Sciences And Hospital |
SDMCMSH
MANJUSHREE NAGAR
SATTUR DHARWAD
580009
Dharwad
KARNATAKA |
9765277877
shivanishanbhag96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ALL NURSES OF SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL WILL BE ENROLLED IN THIS STUDY |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Nurses within the age group of ≥25 and ≤50 years of either gender
2. Nurses with work experience of more than 1 year 23,27, 30
3. Nurses working on duty minimum 40 hours per week. 20, 27
4. Presently working as staff of SDM hospital.
5. Those willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Radiculopathy due to any cause and other neurological disorders.
2. Any progressive, systemic or other musculoskeletal diseases.
3. Nurses with history of fractures in the lower extremity within the past 6 months – 1 year which would alter the mechanics of the lower extremity. 31
4. Nurses with history of surgeries of the lower extremity within the past 6 months- 1 year. 31
5. Nurses in administrative section |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.FOOT POSTURE INDEX
2. ANKLE MUSCLE STRENGTH
3.ANKLE RANGE OF MOTION
4.LIMB LENGTH DISCREPANCY
5. BODY MASS INDEX
6. NUMBER HOURS OF WORK PER WEEK
7. NUMBER OF YEARS OF WORK EXPERIENCE
|
BASELINE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NO SECONDARY OUTCOMES |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
Final Enrollment numbers achieved (Total)= "225"
Final Enrollment numbers achieved (India)="225" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2021 |
| Date of Study Completion (India) |
19/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Despite the importance of foot health, research to date has mainly focused on musculoskeletal pain in the nursing profession, with a major focus on other conditions. As nurses represent majority of the working force at any hospital, the development of WMSDs in this group of people may have a significant impact on absences from work, work restrictions or even transfers to other jobs. By finding out the prevalence we get an idea about the burden of the disease in the Indian nursing population. Previous studies have shown that lower extremity musculoskeletal disorders are common amongst nurses, with ankle and foot being more commonly affected. However, to our knowledge, no study yet has found out the prevalence of plantar fasciitis and analyzed its risk factors in nurses. Also, by finding out the prevalence and the number of nurses who have potential risk factors to the development of plantar fasciitis we can create an awareness among them. Hence a strong need arises. |