| 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
|
|
|
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
|
|
|
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.
|