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CTRI Number  CTRI/2024/09/074290 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Reduction of pain in young adults with piriformis syndrome 
Scientific Title of Study   A study on efficacy of short wave diathermy and stretching exercises in reducing pain in young adults with piriformis syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. C.NAGESWARI  
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09843073406  
Fax    
Email  nageswari@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DrC Nageswari 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09843073406  
Fax    
Email  nageswari@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  DrC Nageswari 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09843073406  
Fax    
Email  nageswari@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Galgotias University, Department of Physiotherapy, school of Allied Health Science, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway 
 
Primary Sponsor  
Name  Galgotias University 
Address  Department of Physiotherapy, school of Allied Health Science, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway 
Type of Sponsor  Research institution 
 
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 
DrC Nageswari  Physiotherapy Department, Galgotias university  Department of Physiotherapy, school of Allied Health Science, Room No 315, Galgotias University, Third floor, , Gautam Buddha Nagar Sector 17 A, Yamuna Expressway
Gautam Buddha Nagar
UTTAR PRADESH 		 09843073406

nageswari@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DEPARTMENTAL RESEARCH COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Piriformis syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  short wave diathermy   8 weeks 
Comparator Agent  Stretching exercises  8 weeks 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Young Adult students of Galgotias University with age group between 17 to 24 years having back pain and posterior thigh pain willing to participate in this study 
 
ExclusionCriteria 
Details  Young male and female with age group more than 25 and less than 17.
Young male and female with chronic problem
Any sort of juvenile arthritis, disc prolapse any recent surgery.
Having any type of neurological deficit (motor, sensory and reflex).
Requiring any type of urgent intervention(s) due to low back pain.
Having a history of cardiovascular disease which would prevent exercise.
Having radicular pain.
Being pregnant.
• Having severe osteoporosis or osteomalacia.
Uncontrolled DM, hypertension.
Having any infectious disease, rheumatic disease or history of malignancy.
Having any condition preventing the use of SWD therapy.
Spondylolisthesis or history of back surgery.
Having received electrotherapy program within the last six months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To reduce the symptoms of piriformis syndrome  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the flexibility of back  8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/10/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Piriformis Syndrome is a pain in the pelvic area caused by prolonged or excessive Contraction of the piriformis muscle so that the sciatic nerve is compressed. The Physiotherapy treatment used is a combination of SWD (short wave diathermy) and stretching. This study aimed to determine the effect of a combination of SWD and stretching in reducing pain in piriformis Syndrome patients.

 
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