| 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
|
|
|
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
|
|
|
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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