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CTRI Number  CTRI/2025/09/094974 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of exercises on pain and quality of life in individuals with deep hip pain 
Scientific Title of Study   The Effect Of Pilates On Pain And Quality Of Life In Individuals With Piriformis Syndrome A Quasi 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  Amreza De Oliveira  
Designation  Master of physiotherapy student 
Affiliation  Goa Medical College and Hospital 
Address  Mark Residency Block B Ground floor ST Caitan Waddo Merces Goa
Goa Medical College and Hospital N17 Bambolim Tiswadi Goa India pincode 403202
North Goa
GOA
403005
India 
Phone  9604698344  
Fax    
Email  amrezad13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Alisha Gracias 
Designation  Assistant professor in Physiotherapy  
Affiliation  Goa Medical College and Hospital 
Address  Assistant professor in Physiotherapy Allied health science courses Department of orthopaedics Goa medical college and hospital Bambolim Tiswadi Goa India 403202
Goa Medical College and Hospital N17 Bambolim Tiswadi Goa India pincode 403202
North Goa
GOA
403202
India 
Phone  9881887175  
Fax    
Email  alisha.gracias@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alisha Gracias 
Designation  Assistant professor in Physiotherapy  
Affiliation  Goa Medical College and Hospital 
Address  Assistant professor in Physiotherapy Allied health science courses Department of orthopaedics Goa medical college and hospital Bambolim Tiswadi Goa India 403202
Goa Medical College and Hospital N17 Bambolim Tiswadi Goa India pincode 403202
North Goa
GOA
403202
India 
Phone  9881887175  
Fax    
Email  alisha.gracias@gmail.com  
 
Source of Monetary or Material Support  
Goa Medical College and Hospital 
 
Primary Sponsor  
Name  Amreza De Oliveira  
Address  Goa Medical College and Hospital N17 Bambolim Tiswadi Goa India 403202 
Type of Sponsor  Other [self] 
 
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 
Dr Amreza De Oliveira  Goa Medical College and Hospital  Goa Medical College and Hospital N17 Bambolim Tiswadi Goa India 403202
North Goa
GOA 
9604698344

amrezad13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Medical College Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M791||Myalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Pilates   The experimental group will be given a four week intervention of pilates .The intervention will be given 3 times a week for 4 weeks which include application of hot pack to the gluteal region before the intervention for 10 minutes warm up for 5 minutes Pilates exercise programme for 20 minutes cool down for 5 minutes application of hot pack to the gluteal region again to relax the muscle for 10 minutes . Exercises will be progressed at each participants level of tolerance and reassessed again following 2 and then 4 weeks of the intervention with outcome measures of pain with visual analogue scale and quality of life with RAND SF 36 questionnaire. Participants will be provided with a diary to tick mark the sessions done. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants in the age group of 40 to 60 years of all genders
Unilateral gluteal pain for more than or equal to 3 months
Visual analogue scale score more than or equal to 4.
Participants meeting the diagnostic criteria (FAIR Pace Freiberg test positive)
Single leg raise test negative
Pain radiating down the posterior thigh
Pain on palpation of greater sacrocygeal notch and or piriformis muscle
Participants willing to participate and provide informed consent

 
 
ExclusionCriteria 
Details  Participants with confirmed lumbar spine pathology (disc herniation or spinal stenosis or lumbar radiculopathy)
Prior surgery or history of trauma to hip or spine or pelvis region or gluteal abcess or hip infection or sacroileac joint dysfunction
Neurological disorders (diabetic neuropathy or multiple sclerosis or myasthenia gravis)
Pregnancy or post partum less than 8 months
Botox in last 6 months and corticosteroid or local anesthethic injection in last 12 months in gluteal region.
Participants on pain medications and muscle relaxants
Participants undergoing physiotherapy for piriformis syndrome or low back pain in last 6 months .
Participants with diagnosed cases of cauda equina syndrome,autoimmune or inflammatory conditions like rheumatoid arthritis, systemic lupus erythrematosis, ankylosing spondylitis.
Participants reporting urinary or bowel or perineal or pelvic cavity related symptoms suggestive of pelvic floor dysfunction
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Visual Analog Scale
2.RAND SF 36  
T0- Baseline
T1- Mid intervention after 2 weeks
T3- Post intervention after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2025 
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="1"
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  

     Piriformis syndrome is an underdiagnosed source of sciatica like symptoms and deep gluteal discomfort it frequently results in decreased mobility and a reduced quality of life. Conventional physiotherapy interventions typically include stretching and manual therapy but these methods might not be sufficient to address the underlying neuromuscular and biomechanical dysfunctions such as weak hip muscles and poor lumbopelvic control. Although there is little data on its effectiveness in treating piriformis syndrome pilates based exercises that emphasize hip and lumbar dissociation core stability and neuromuscular reeducation have demonstrated advantages in related musculoskeletal disorders.


The purpose of this quasi-experimental study is to assess how a 4 week pilates intervention programme will affect pain and quality of life in people with piriformis syndrome who are 40 to 60 years old.  At Goa Medical College and Hospital thirty volunteers who meet the diagnostic requirements of a positive FAIR, pace and freiberg tests will be chosen using convenience sampling. The intervention will consists of pilates program of posterior hip strengthening exercises hip dissociation and lumbar dissociation exercises which will be given three times a week for four weeks.The Visual Analogue Scale for pain and the RAND SF 36 questionnaire for quality of life will be used to measure the results before and during and after the intervention.


The findings from this study will help determine the effect of pilates exercises which are low cost non invasive culturally appropriate rehabilitation program that could enhance the conservative treatment of piriformis syndrome in Indian population.


 
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