| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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. |