| CTRI Number |
CTRI/2024/09/074443 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pilates in hair dressers of belagavi city with non-specific low back pain |
|
Scientific Title of Study
|
Effectiveness of Pilates on Pain, Function, Core strength, and Quality of Life in Hairdressers with Non-Specific Low Back Pain- A Pre-Post Experimental 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 |
BIKESH CHAUDHARY |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room number 39, Advanced Physiotherapy centre, Sagar floor, KLE PBK Hospital, Nehru Nagar, Belagavi,Kanataka INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
07892041849 |
| Fax |
|
| Email |
bkschy03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepti Bagewadi |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room number 39, Advanced Physioherapy centre,Sagar floor, KLE PBK Hospital, Nehru Nagar, Belagavi,Karnataka,INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9964608727 |
| Fax |
|
| Email |
deeptibagewadi@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Kanabur |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room number 39, Advanced Physiotherapy centre,Sagar floor, KLE PBK Hospital, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 39,Advanced Physiotherapy Centre, Sagar floor, KLE PBK Hospital, Nehru Nagar, Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Bikesh Chaudhary |
| Address |
Room number 39, Advanced Physiotherapy centre,Sagar floor, KLE PBK Hospital, Nehru Nagar, Belagavi, 590010, Karnataka, 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 |
| Dr Vijayalaxmi Kanabur |
Various Hair Salons in Belagavi city |
Belagavi North and South
Belgaum
KARNATAKA |
8867480565
vvkdeeksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical committe, KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-specific low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Pilates exercise |
Pilates exercise will be given 4 times per week for 4 weeks, total of 16 sessions. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female hairdressers of Belagavi city with minimum 2 years of experience
2.Age: 21-45 years
3.Those willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of musculoskeletal deformity or neurological disorders
2.Diagnosed cases of any medical or surgical condition known to be a cause for Low Back Pain
3.Those participating in regular physical exercise in the past 6 months.
4.Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain using Numeric Pain Rating Scale, Function using Modified Oswestry Disability Index, Core strength using Pressure Biofeedback and Quality of Life using SF-36. |
Baseline
Re-assessment after 2 and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
01/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Effectiveness of Pilates on Pain, Function, Core strength and Quality of life in Hairdresers with Non-Specific Low Back Pain- A Pre-Post Experimental study Aim of the study: To determine the effectiveness of Pilates exercise program on pain, function, core strength and quality of life in hairdressers with nonspecific low back pain Null hypothesis(Ho): There will be no effect of Pilates exercise program on pain, function, core strength and quality of life in hairdressers with non-specific low back pain. Alternate Hypothesis(H1): There will be effect of Pilates exercise program on pain, function, core strength and quality of life in hairdressers with non-specific low back pain. Inclusion criteria: Male and female hairdressers of Belagavi city with minimum 2 years of experience, Age: 21-45 years, Those willing to participate in the study. Exclusion Criteria: Diagnosed cases of musculoskeletal deformity or neurological disorders, Diagnosed cases of any medical or surgical condition known to be a cause for Low Back Pain, Those participating in regular physical exercise in the past 6 months., Pregnancy Participants will be screened as per the inclusion and exclusion criteria. The purpose and procedure of the study will be explained to the participants before commencement of the study. A written informed consent will be obtained from the participants and baseline pre assessment will be done. For Pain, Pain score will be taken using Numeric Pain Rating Scale, Functions will be evaluated using Modified Oswestry Disability Index, Core strength will be evaluated using Pressure Biofeedback and Quality of life using SF-36 questionnaire. Then, the patient will be enrolled in the four weeks of the intervention program which will be supervised. The exercise will be given 4 times per week for total of four weeks. The participants will be re-assessed at the end of the 2 weeks and the final assessment will be done at the end of 4th weeks for Pain, Function, core strength and Quality of life. |