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CTRI Number  CTRI/2024/03/064202 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Physiotherapy on pain, physical function and health related quality of life of Bharatanatyam dancers 
Scientific Title of Study   Study on the short-term and long-term effects of Physiotherapy intervention on musculoskeletal pain, physical function and health related quality of life of Bharatanatyam dancers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akhila Natesan 
Designation  Assistant Professor/ PhD Scholar 
Affiliation  MGM School of Physiotherapy 
Address  1 st Floor, room no-115, Out Patient Department , Department of Physiotherapy, MGM Hospital, Kamothe Plot no 1 and 2,Sector-1 Navi Mumbai. Taluka Panvel Raigarh

Raigarh
MAHARASHTRA
410209
India 
Phone  9167314945  
Fax    
Email  anatesan@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajani Mullerpatan 
Designation  Prof Director 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  1 st Floor, room no-115, Out Patient Department , Department of Physiotherapy, MGM Hospital, Kamothe Plot no 1 and 2,Sector-1 Navi Mumbai. Taluka Panvel Raigarh


MAHARASHTRA
410209
India 
Phone    
Fax    
Email  rajani.kanade@googlemail.com  
 
Details of Contact Person
Public Query  
Name  Akhila Natesan 
Designation  Assistant Professor/ PhD Scholar 
Affiliation  MGM School of Physiotherapy 
Address  1 st Floor, room no-115, Out Patient Department , Department of Physiotherapy, MGM Hospital, Kamothe Plot no 1 and 2,Sector-1 Navi Mumbai. Taluka Panvel Raigarh


MAHARASHTRA
410209
India 
Phone  9167314945  
Fax    
Email  anatesan@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM Institute of Health Sciences infrastructure and material support 
 
Primary Sponsor  
Name  MGM Institute of Health Science 
Address  Sector-1, Kamothe, Panvel, Navi Mumbai, 410209 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akhila Natesan  MGM School of Physiotherapy   Room no.1, MGM Centre of Human Movement Science and Physiotherapy OPD,Physiotherapy department, 1st floor, MGM Superspeciality hospital, Vashi Sector 30A, Navi Mumbai- 400703
Thane
MAHARASHTRA 		 9167314945

anatesan@mgmsopnm.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core strengthening, static and dynamic quadriceps, squat, lunges, upper limb strengthening, stretching of thoracolumbar fascia, quadriceps and hamstrings stretch, gastrocnemius stretching  Physiotherapy intervention specific to pain relief progressed for 1 year (52 weeks) Frequency (dose) - once a day 6 days/week Intensity - level of exertion 3-5 on modified Borg scale Time - 20 mins Type- strength and flexibility training route of administration - not applicable 
Comparator Agent  Skipping, running, spinal rotations, cat camel exercises,bilateral leg raises, closed chain body weight training, plank, push ups, trikonasana, hastapadasan, janushirsanana,balancing on wobble board, mattress, one leg stance balancing   Conventional exercises will be given to dancers for specific physiologic stresses of Bharatanatyam for 1 year (52weeks) weeks) Frequency (dose) - once a day 6 days/week Intensity - level of exertion 5-7 on modified Borg scale Time - 20 mins Type- aerobic, agility, strength and flexibility training route of administration - not applicable 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Bharatanatyam dancers receiving training for more than 5 years with intention to continue for more than 1 year with and without either knee pain, low back pain or both 
 
ExclusionCriteria 
Details  Dancers with history of injury or trauma within past six months. Receiving training or previously trained in other dance forms. Dancers with history of neurological, metabolic, autoimmune, cardiopulmonary or systemic illness. Dancers currently pregnant or delivered a child within one year. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knee pain or low back pain   Time point 1: Baseline
Time point 2-12: Every 4 weeks (1 month for a period of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
2. Core and skeletal muscle endurance, spinal and lower extremity flexibility, Functional movement screening  Time point 1: Baseline
Time point 2-4: tested every 12 weeks (3 months) 
3. Cardiorespiratory endurance, dynamic foot posture and pressure, Gait and dance posture kinematic and kinetic outcomes, Health Related Quality of Life  Time point 1: Baseline
Time point 2-3:Every 6 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   Phase 4 
Date of First Enrollment (India)   27/03/2024 
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="4"
Months="0"
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   A survey will be conducted to identify 90 Bharatanatyam dancers with either knee pain or low back pain or both and 90 Bharatanatyam dancers without any history of either knee pain or low back pain or both.
Following screening for inclusion and exclusion criteria, informed consent shall be obtained from the 180 female Bharatanatyam dancers. 
A baseline evaluation of history of injury, musculoskeletal pain profile will be conducted, Clinical tests will be used to test core muscle endurance, posture, spinal and lower extremity flexibility. Dynamic foot posture will be assessed using Novel emed device, 3D motion analysis system will be used to assess gait and dance posture kinematics and kinetics. Cardiorespiratory endurance will be assessed during submaximal test using Cosmed Fitmate Med device, Health Related Quality of Life (HRQOL) will be assessed using modified diablement in physically active scale. 
Physiotherapy intervention specific to pain relief and physiologic stresses of Bharatanatyam will be given to 180 dancers. A monthly log of injury and pain will be maintained to determine incidence of any new injuries or pain. Core and skeletal muscle endurance, spinal and lower extremity flexibility, will be tested every 3 months (12 weeks). Cardiorespiratory endurance, dynamic foot posture and pressure, Gait and dance posture kinematic and kinetic outcomes, HRQOL will be tested every 6 months. After one year intergroup and intra group comparisons will be conducted using statistical tests on SPSS software. 
This study will help develop physiotherapy protocols for prevention and rehabilitation of knee, low back pain and injuries among Bharatanatyam dancers.
 
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