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CTRI Number  CTRI/2026/04/108918 [Registered on: 21/04/2026] Trial Registered Prospectively
Last Modified On: 20/04/2026
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 DFL MFR And AJM On Pain, Function And Balance In Individuals With Knee Osteoarthritis  
Scientific Title of Study   Effect Of Deep Frontline Myofacial Release And Ankle Joint Mobilisation On Pain, Function And Balance In Individuals With Knee Osteoarthritis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thakkar Prachi Bankim 
Designation  Post Graduate Student  
Affiliation  Ahmedabad Institute Of Medical Sciences  
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9099976749  
Fax    
Email  prachithakkar12345@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Kanna Amaranth  
Designation  Lecturer And PG Guide  
Affiliation  Ahmedabad Institute Of Medical Sciences  
Address  Room No. 1, Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences near S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9943787226  
Fax    
Email  ruthracha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr T Kanna Amarnath  
Designation  Lecturer and PG Guide 
Affiliation  Ahmedabad Institute Of Medical Sciences  
Address  Room No. 1, Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences near S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9943787226  
Fax    
Email  ruthracha@gmail.com  
 
Source of Monetary or Material Support  
Ahmedabad Institute Of Medical Sciences near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad  
 
Primary Sponsor  
Name  Ahmedabad Institute Of Medical Sciences  
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad  
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 
Dr T Kanna Amarnath  Ahmedabad Institute Of Medical Sciences   Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences near SP Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT 
9943787226

ruthracha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional knee pain therapy  Static quadriceps exercises, knee and hip strengthening Exercises followed by hotpack for 10 mins 
Intervention  Deep Front Line Myofascial Release   5 sessions for 2 weeks and conventional therapy with hotpack  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subject willing to participate in the study
Age: 45 to 65 ( Middle Adulthood and Later Adulthood)
Gender: Male and Female
Bilateral Knee Osteoarthritis(ACR Guidelines)
VAS: 3-7
 
 
ExclusionCriteria 
Details  Individuals with Neurological symptoms and disorders
Individuals with Congenital disorders
Surgery to the lower limb
Any Cardiovascular conditions  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale   Before Treatment at Baseline and After Treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Western Ontario McMaster Universities Osteoarthritis Index   Before Treatment at Baseline & After Treatment  
Berg Balance Scale   Before Treatment at Baseline & after Treatment  
 
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)   01/05/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   INTRODUCTION
Knee osteoarthritis (OA) is a highly prevalent degenerative joint disorder, leading to chronic pain, functional limitations, and impaired balance, which collectively reduce quality of life and independence in affected individuals.  The multifactorial etiology of knee OA includes not only articular cartilage degeneration but also alterations in periarticular soft tissues, such as the fascia and myofascial chains, which play a significant role in force transmission and joint alignment. Recent research has highlighted the importance of myofascial dysfunctions, particularly within the deep front line (DFL) fascial chain, as contributors to pain, malalignment, and movement dysfunction in knee OA.  Myofascial trigger points and increased fascial tension are frequently observed in these patients and are associated with higher pain levels and greater disability. Myofascial release (MFR) techniques, especially those targeting the DFL, have demonstrated significant improvements in pain, function, and even radiological alignment in individuals with knee OA.  Ankle mobility is another critical factor in the kinetic chain, as restricted dorsiflexion and altered biomechanics can increase stress on the knee joint and further impair balance and function.  Techniques such as myofascial release and joint mobilisation have been shown to improve ankle range of motion, pain, and functional outcomes, suggesting that addressing both fascial and joint mobility may have synergistic benefits.

NEED OF THE STUDY  
There is a high prevalence of myofascial dysfunctions and trigger points in individuals with knee osteoarthritis (OA), which contribute significantly to pain and functional limitations. Deep front line (DFL) myofascial release has shown immediate and substantial reductions in pain (up to 50–100%) and improvements in function and quality of life in knee OA patients, but research on its combined use with other interventions is limited. Ankle mobility deficits are common in knee OA and can exacerbate knee pain, impair function, and negatively affect balance; myofascial release and mobilisation techniques targeting the ankle have demonstrated improvements in range of motion and function. Most existing studies have focused on either myofascial release or joint mobilisation alone, with a lack of research evaluating the combined effect of DFL myofascial release and ankle mobilisation on pain, function, and balance in knee OA. Addressing both myofascial and joint mobility components may provide a more comprehensive and effective physiotherapy approach, potentially leading to superior outcomes in pain relief, functional improvement, and balance restoration. There is a need for high-quality, integrated research to guide clinical practice and optimize rehabilitation protocols for individuals with knee OA.


AIM 

To study the effect of deep front line myofascial release combined with ankle joint mobilisation on pain, function and balance in individuals with knee osteoarthritis.


OBJECTIVES

  • To evaluate the effect of deep front line myofascial release combined with ankle joint mobilisation on knee pain in individuals with knee osteoarthritis by using Visual analog scale(VAS).
  • To evaluate the effect of deep front line myofascial release combined with ankle joint mobilisation on knee function in individuals with knee osteoarthritis by using Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC).
  • To evaluate the effect of deep front line myofascial release combined with ankle joint mobilisation on knee balance in individuals with knee osteoarthritis by using Berg Balance Scale.
  • To evaluate the effect of conventional treatment on knee pain in individuals with knee osteoarthritis by using Visual analog scale(VAS).
  • To evaluate the effect of conventional treatment with on knee function in individuals with knee osteoarthritis by using Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC).
  • To evaluate the effect of conventional treatment on knee balance in individuals with knee osteoarthritis by using Berg Balance scale.
  • To compare the effect of deep front line myofascial release combined with ankle mobilisation and conventional treatment on knee pain in individuals with knee Osteoarthritis by using Visual Analog scale(VAS).
  • To compare the effect of deep front line myofascial release combined with ankle mobilisation and conventional treatment on knee pain in individuals with knee Osteoarthritis by using Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC).
  • To compare the effect of deep front line myofascial release combined with ankle mobilisation and conventional treatment on knee pain in individuals with knee Osteoarthritis by using Berg Balance scale.
PROCEDURE
  • After the institutional ethical and research committee approval, participants will be selected according to the inclusion and exclusion criteria.
  • Explanation of the study to the patients and a written consent will be signed by the individual.
  • Participants will be allotted into two groups

             Group A: Experimental group- DEEP FRONT LINE MYOFASCIAL RELEASE COMBINED WITH ANKLE JOINT MOBILISATION + CONVENTIONAL THERAPY 

             Group B: Conventional group- CONVENTIONAL THERAPY 

Outcome measures will be recorded before and after the intervention.



 
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