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CTRI Number  CTRI/2023/12/060619 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The study is to compare two techniques myofascial release that involves applying gentle pressure in order to release tension and tightness in the tissue and foam roller that reduces pain and improves ankle range in dorsiflexion( the upward movement of the foot towards the shin).  
Scientific Title of Study   The Effect Of Myofascial Release Versus Foam Roller On Decreasing Pain And Improving Dorsiflexion Range Of Motion Of Ankle Joint In Patients With Plantar Fascitis -A Randomized Control Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deborah Borgai  
Designation  Post Graduate Student 
Affiliation  Narayana Hrudayalaya  
Address  258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore 560099

Bangalore Rural
KARNATAKA
560099
India 
Phone  9606528862  
Fax    
Email  deborah.borgai1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Smruti Swagatika Dash 
Designation  professor  
Affiliation  Narayana Hrudayalaya  
Address  258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore 560099

Bangalore Rural
KARNATAKA
560099
India 
Phone  9448552026  
Fax    
Email  ssdashpt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deborah Borgai  
Designation  Post Graduate Student 
Affiliation  Narayana Hrudayalaya  
Address  258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore 560099


KARNATAKA
560099
India 
Phone  9606528862  
Fax    
Email  deborah.borgai1@gmail.com  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya Foundation-BANGALORE 560099 
 
Primary Sponsor  
Name  Deborah Borgai  
Address  Narayana Hrudayalaya Foundations 258/A, Health City Bommasandra Industrial Area, Anekal Taluka, Bangalore-560099  
Type of Sponsor  Private hospital/clinic 
 
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 
Deborah Borgai   Narayana Orthopaedic Spine and Trauma care  Physiotherapist department ,OPD
Bangalore Rural
KARNATAKA 
9606528862

deborah.borgai1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparision between myofascial release and foam roller  myofacial release is given for 20 repetations in ankle dorsiflexed position and foam roller will be given under the affected sole for 2 min. 
Comparator Agent  Comparision between myofascial release and foam roller  myofacial release is given for 20 repetations in ankle dorsiflexed position and foam roller will be given under the affected sole for 2 min.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group above 18 years
Both males and females.
Both unilateral and bilateral limb involvement
Subjects having sharp acute pain on the first step in the morning
Patients who are having the history of prolonged standing 
 
ExclusionCriteria 
Details  Subjects with calcaneal spur
Subjects with systemic disorders
Subjects with neurological disorder/ musculoskeletal disorders
Fractures in and around ankle joint
Subjects who have undergone prior orthopaedic surgery 
 
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 
VAS for assessing pain
FFI for assessing range of motion
 
at baseline and after 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
range of motion   4 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2023 
Date of Study Completion (India) 30/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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 & BACKGROUND
Plantar fasciitis, is also known as plantar heel pain and it is a soreness, which affects the bottom of the
foot1. The most typical cause of pain in the inferior heel is plantar fasciitis. Fasciitis implies
inflammation which is a fundamental aspect of this illness. Which is due to biomechanical stress.When plantar fasciitis develops, the pain
is frequently severe and, in 70% of cases, unilateral. Putting weight on the heel after extended periods
of rest exacerbates heel discomfort in those who are affected. People with plantar fasciitis frequently
say that the first few steps after getting out of bed or during extended periods of sitting are when their
pains are the worst
Symptoms often get better as you keep walking. Numbness, tingling, swelling, or radiating pain are
typical symptoms. Normally, there are no fevers or sweats at night. A review suggested that it be
renamed "Plantar Fasciosis," "Painful Heel Syndrome," "Runner’s Heel," "Tennis Heel," as
inflammation either plays a minor or non-existent function.The foot often assumes a plantar flexed
position at night, and when a patient gets out of bed in the morning, the foot assumes a dorsiflexed
position when walking. In bed, the plantar fascia gradually contracts, and the initial stretching that
comes with waking up early in the morning is probably what causes the initial soreness.
Plantar fasciitis is most common in adults between the ages of 40 and 60, with no preference for either
gender.
A soft tissue mobilization treatment called myofascial release (MFR) is utilized for long-term disorders
which cause tightness and constriction in soft tissues. By changing the ground substance’s viscosity to
a more fluid state, myofascial release therapy relieves the fascia’s excessive pressure on the pain-
sensitive structure and returns the body to its natural alignment. So, it is suggested that this method
serve as a catalyst in the resolution of plantar fasciitis.
The goal of the direct MFR approach is to increase soft tissue mobility by using gradual fingers, thumbs,
forearms, or elbows to apply regulated mechanical stress directly into a limitation. The amount of
pressure is progressively increased or applied repeatedly until the tissue’s mobility is perceived to improve
Roller massagers are held in the hands, which are made of plastic, while foam rollers are cylinders made
of foam in varying densities and textures. Similar to conventional myofascial release, these tools use
pressure that is applied by the patient either externally or with their own body weight.
Foam roller has been the subject of recent and ongoing research. Foam roller has also been demonstrated
to possibly lessen stiffness and the pain brought on by delayed onset muscle soreness. Foam roller is
well-respected in the fields of rehabilitation and strength and conditioning for promoting healing and
extending joint range of motion. Few studies have been published that have found that chronic foam
roller technique increases range of motion measures. Foam rollers and roller massagers are often
employed tools to promote myofascial mobility. In order to exert pressure on the soft tissues while
rolling with a foam roller, the clients employ their body weight.

AIMS AND OBJECTIVE
AIM: To find out the effectiveness of myofascial release and foam roller on decreasing pain and
improving dorsiflexion range of motion of ankle joint in patients with plantar fasciitis.
OBJECTIVES:
PRIMARY OBJECTIVE -
To compare the efficacy of myofascial release and foam roller in patients with plantar fasciitis.
SECONDARY OBJECTIVE -
To evaluate the pain and range of motion by using myofascial release in patients with plantar fasciitis.
Evaluating the myofascial release and foam roller effectively reduces pain.
To assess the myofascial release and foam roller are effective in improving ankle function.

Selection criteria

Inclusion Criteria:
ï‚· Age group above 18 years
ï‚· Both males and females.
ï‚· Both unilateral and bilateral limb involvement
ï‚· Subjects having sharp acute pain on the first step in the morning
ï‚· Patients who are having the history of prolonged standing

Exclusion criteria
ï‚· Subjects with calcaneal spur ,
ï‚· Subjects with systemic disorders,
ï‚· Subjects with neurological disorder/ musculoskeletal disorders,
ï‚· Fractures in and around ankle joint,
ï‚· Subjects who have undergone prior orthopaedic surgery,

METHODOLOGY

Experimental group: This group will undergo myofascial release with conventional therapy (stretching,
towel curl, heel raise, contrast bath are the standard protocol of myofascial release)
In stage 1: myofascial release 20 repetitions will be given. The ankle will be dorsiflexed during the
application. Myofascial release will be applied with the dorsal part of the hand and pressure will be
given over the superficial layer by sliding towards the calcaneus from the affected area.
Stage 2: is done for deep tissue release. The patient will be in prone lying with the knees flexed position
and ankle is kept in normal position. The therapist holds the anterior part of the ankle by hand and with
another forearm applies the myofascial technique and gives pressure over the affected side of plantar
aponeurosis.
Stage 3: for Achilles tendon were a small roll will be placed under the ankle, or the foot is off the bed
so that the foot and ankle are in forced plantar flexion. The superior hand will be placed over the superior
aspect of the Achilles tendon. Then the tissue will be forced perpendicular to the tibia. Then the superior aspect and inferior aspect of the tendon are compressed together bringing the two ends of the tendon
closed together and the compressive force was maintained.
Stage 4: is done for the gastrocnemius muscle where the patient is in prone lying position. The therapist
used both hands in a cross-hand pattern and apply Myofascial release over the gastrocnemius muscle
The Range of motion, VAS, and FFI these outcome measures that will be used and will be assessed pre
and post-intervention.
Control group: This group will undergo foam roller along with conventional therapy (stretching, towel
curl, heel raise, contrast bath are the standard protocol of myofascial release)
Participants will be instructed to be in a standing position. A foam roller will be given to roll under the
affected sole starting from behind the head of metatarsals towards the heel focusing on the medial arch
for 2 minutes. They will be asked to exert maximum pressure, till a point of discomfort but not pain. It
will be given for 4 weeks. The outcome measures will be assessed pre and post-intervention.
 
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