FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/054422 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 24/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of flossing treatment on improving pain & strength of thigh muscles in knee pain patients 
Scientific Title of Study   Efficacy of Tissue flossing in improving pain & strength of quadriceps on Patellofemoral pain syndrome A Randomized Clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaya P 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy Father Muller Medical College, Kankanady, Mangaluru-575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9611057292  
Fax    
Email  jayakulal55@fathermuller.in  
 
Details of Contact Person
Scientific Query  
Name  Jaya P 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy Father Muller Medical College, Kankanady, Mangaluru-575002


KARNATAKA
575002
India 
Phone  9611057292  
Fax    
Email  jayakulal55@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Jaya P 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Physiotherapy Father Muller Medical College, Kankanady, Mangaluru-575002


KARNATAKA
575002
India 
Phone  9611057292  
Fax    
Email  jayakulal55@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital Kankanady, Mangaluru 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Father Muller Medical College Father Muller Road, Kankanady, Mangaluru-575002 
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 
Jaya P  Father Muller Medical College Hospital  Department of Physiotherapy Outpatient unit Father Muller Road Kankanady, Mangaluru
Dakshina Kannada
KARNATAKA 		 9611057292

jayakulal55@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M998||Other biomechanical lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard intervention  Standard intervention 30 minutes per day twicw a week for 4 weeks 
Intervention  Tissue flossing  Standard treatment and additionally Tissue flossing intervention 30 minutes per day twicw a week for 4 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Women 20 to 40 years of age who had a history of anterior knee pain for at least 3 months
- Reported increasing pain in 2 or more activities that commonly provoke PFPS, as outlined
by Thomeé et al.13
- These activities included ascending and descending stairs, squatting, kneeling, jumping,
long sitting, isometric knee extension contraction at 60° of knee flexion, and pain on
palpation of the medial and/ or lateral facet of the patella.
- Sedentary, defined as not having practiced physical activity (aerobic and strengthening
exercises) any day of the week for at least 6 months previously. 
 
ExclusionCriteria 
Details  - They had a neurological disorder; injury to the lumbosacral region, hip, or ankle;
rheumatoid arthritis, a heart condition, or previous surgery involving the lower extremities; or
were pregnant or using corticosteroids or anti-inflammatory medication.
- Women who had other knee pathologies, such as patellar instability, patellofemoral
dysplasia, meniscal or ligament tears, osteoarthritis, or tendinopathies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain using NPRS and Strength using Dynamometer  Pre treatment, post treatment and 4 weeks folloup 
 
Secondary Outcome  
Outcome  TimePoints 
Flexibility, Function  Passive knee extension test (passive 90/90 test), Lower Extremity Functional Scale measured pre intervention post intervention & 4 weeks follow up(LEFS) 
 
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)   03/07/2023 
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="2"
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  
Purpose of this study was to determine if adding tissue flossing along with conventional strengthening exercises would produce better long-term outcomes than conventional knee exercises alone in women with PFPS. We hypothesized that the group that included tissue flossing would demonstrate significantly better results in strength and flexibility at immediately and 1-month follow-up assessments.
 
Close