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CTRI Number  CTRI/2022/09/046034 [Registered on: 29/09/2022] Trial Registered Prospectively
Last Modified On: 07/03/2023
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   Plantar Intrinsic Muscle Training Program in patients with Plantar Fascitiis. 
Scientific Title of Study   Effect of 4 weeks of plantar intrinsic muscle training program on pain and functional recovery in patients with plantar fascitiis- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karishma Bhandari 
Designation  Post Graduate Student 
Affiliation  Pravara Institute of Medical Sciences  
Address  403, Orthopaedic physiotherapy department, Dr. APJ Abdul kalam college of physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8530367067  
Fax    
Email  bhandarikarishma@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Borkar 
Designation  Associate Professor 
Affiliation  Pravara Institute of medical sciences 
Address  403, Orthopaedic physiotherapy department, Dr. APJ Abdul kalam college of physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9168572881  
Fax    
Email  pnb2609@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karishma Bhandari 
Designation  post- graduate student 
Affiliation  Pravara Institute of medical sciences 
Address  403, Orthopaedic physiotherapy department, Dr. APJ Abdul kalam college of physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  08530367067  
Fax    
Email  bhandarikarishma@ymail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences ,Loni, Tal- Rahata , Dist-Amhednagar 413736 
 
Primary Sponsor  
Name  DR APJ Abdul Kalam College of Physiotherapy 
Address  Dr.APJ Abdul Kalam College Of Physiotherapy, Pravara Institute Of Medical Sciences,Loni 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Karishma Bhandari  Pravara Rural hospital  dept no 403 DR. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences,Loni 413736 Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
08530367067

bhandarikarishma@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of dr. APJ Abdul Kalam COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Training Program  Patients will perform the conventional training exercises for plantar fasciitis Warm up will include the stretches of lower leg Exercises will include plantar fascia stretching Range of motion exercises and toe curls  
Intervention  Plantar intrinsic muscle training program  1 Warm up a dorsi flexion b plantar flexion c inversion d eversion 2 Flexibility Exercise a Plantar Fascia Stretch b Standing calf stretch c Roll Plantar Fascia with frozen bottle 3 intrinsic Muscle Strengthening a Toe towel Scrunches b Toe extension c Ball Roll d Heel Raise e Ankle Inversion with resistance 4 COOL DOWN Range of motion exercises and stretching frequency 3 times a week duration 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patient willing to participate
2.Both men and women
3.Age group 18-40 years
4. Patients with plantar fasciitis
5. Patients with pain scale 2-4 on NPRS
 
 
ExclusionCriteria 
Details  1.Any type of deformity of ankle
2.Any recent soft tissue, traumatic injuries
3.Any recent surgery history
4.Any neurological deficit
5.Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain
2.Foot Functional Recovery
 
week0-week4
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in functional abilities in patients
2.Fear of Exercise/movement in patient (kinesiophobia)
 
week0-week4 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/10/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Plantar fasciitis is one of the most common musculoskeletal disorders of the foottreated in primary care. It is thought toresult from chronic overload either from lifestyle or exercise and affects both elderly andathletic populations.

At present, plantar fasciitis (PF) is considered to be one of the main foot disorders,with an estimated prevalence of 7% in the general population, and among athletes,PF disturbance is more prevalent in runners, being present in up to 17.4% of the runningpopulation. According to its Etiology, PF has been described as a degenerative softtissue condition, related to pain, functionality disorders and stiffness alterations in theplantar fascia. Heel pain was the primary symptom reported by the patients in onestudy. Sub-calcaneal bursitis, plantar nerve disturbances, calcaneal periostitis or heelspur conditions were also frequently reported. PF is an overuse injury, due to the repeated trauma etiology. In thiscontext, muscle and soft tissue inflammation episodes could be associated with one another,but their presence remains doubted and understudied. Individuals with PF reportedthat they experience severe pain when they wake up or following non-activity periods(e.g., sleeping or working sitting down). This condition could develop into a chronicpathology if the symptoms persist over time. Both acute and chronic conditions have been associated with a decrease in quality of life, a lack of functionality and a decrease in sportperformance in sport populations. 

The plantar fascia is an aponeurosis that originates from the medial tubercle of thecalcaneus and extends distally to the phalanges. The Windlass Mechanism is aterm used to describe how the plantar aponeurosis acts like a pulley (Hicks, 1954),developing tension during dorsiflexion of the great toe. This shortens the distance betweenthe calcaneus and the metatarsals, as the aponeurosis winds around the metatarsal headresulting in elevation the medial longitudinal arch. Together with the intrinsicfoot muscles the plantar aponeurosis stabilizes the arch and provides dynamic sensory andmotor control to the foot.In addition to sedentary middle-aged patients, plantar fasciitis isparticularly prevalent in running and dancing activities that require maximal plantarflexion ofthe ankle and dorsiflexion of the metatarsophalangeal joint.

Symptoms are characterized by pain radiating the medial aspect of the heel into the arch offoot. Pain is often most intense with the first steps of the day or after rest or warming up withactivity. As the condition progresses these symptoms can become moredebilitating reducing the patient’s ability to weight bear.

Plantar fasciitis being the most commoncause of rear foot (inferior heel pain) differential diagnosis should not overlook othercommon conditions such as fat pad contusion, and less common conditions such as calcaneal stress and traumatic fractures, medial calcaneal nerve entrapment, lateral plantar nerveentrapment, tarsal tunnel syndrome, talar stress fracture, retrocalcaneal bursitis, along withnot to be missed pathologies such as spondyloarthropathies, osteoid osteoma and post knee orankle injury complex pain syndrome (CRPS Type 1).

There is a broad range of intrinsic and extrinsic riskfactors in the context of PF. The intrinsic risk factors reported were as follows:An excessive body mass index (BMI), reduced toe plantar flexion and restricted ankledorsiflexion, reduced eversion and inversion mobility, Achilles and tibialis tendon disorders,excessive pronation, pes planus or cavus and weakness or disturbances in the intrinsic andplantar foot muscles. The extrinsic risk factors reported were as follows: excessivephysical activity, poor-quality footwear, inadequate surfaces or even walking barefoot. Intrinsic foot muscles (IFMs) play a key role in providing movement and stability tothe ankle and foot; for example, they act as a support for the foot arches. IFMs, such asthe abductor hallucis brevis (AHB), flexor digitorum brevis (FDB) and quadratus plantae(QP), also coordinate with the extrinsic foot muscles, in order to transmit force and mobilityto the foot, and to modify foot stiffness. Therefore, these soft tissue structures havebeen considered a target for study and assessment, due to their importance in the diagnosisand management of ankle and foot disorders.

Plantar fasciitis is more common in middle aged obese women and young athlete’s male. It takes place in patients whose lifestyle causes irregular stretching of the plantar fascia, repetitive microtrauma in runners, prolonged standing and heel spur. Weakness of the extrinsic and intrinsic foot muscles may result in recurrent symptoms of plantar fasciitis as a result of improper joint positioning and functioning of the muscle during walking.Diagnosis of patient with plantarfasciitis can be made through the patient history, clinical manifestations and objective assessments such as level of pain, muscle tightness, palpation, range of motion of joint or muscle strength. Diagnostic imaging may be used to exclude other causes of heel pain as heel spurs or inflammation of tissues. Understanding the anatomy and kinematics of the ankle and foot, the dynamic and static function of the plantar fasciitis during walking and the contributing risk factors associated with plantar fasciitis aid in developing a proper treatment plan and preventative protocol for this condition.

 

 

 

 

 

 

 

 

 

 

 

 

NEED FOR THE STUDY

Previous research has shown increase incidence of plantar fasciitis across the globe and it is 13.6 % in India.

It is been also proved that there is increase in pain in lower extremity and ankle foot complex, along with difficulty in walking. Research statistics has also shown increase in incidence of pain, deformities and accelerated degenerative processin population having plantar fasciitis.

Pain associated with plantarfasciitis cause impaired foot function,significant gait-related disability andstiffness. Plantar fasciitis, if not treatedsoon or properly after the initialsymptoms, it frequently becomes chronicand difficult to resolve. So, patients withplantar fasciitis are in essential need forrehabilitation exercises program toimprove their condition; reducing painand improving functional recovery andfoot function.

Lack of required strength, functional weakness, foot laxity, neuromuscular imbalance etc. are proven intrinsic risk factors for increase in chances, hence it is imperative to design an optimum corrective exercise program to avoid the risk of plantar fasciitis.

 

AIM AND OBJECTIVES

Aim: To study the effect of 4 weeks of plantar intrinsic muscle training program on pain and functional recovery in patients with plantar fasciitis.

Objectives:

1. To study the effect of plantar intrinsic muscle training program on pain with NPRS in patients with plantar fasciitis.

2. To study the effect of plantar intrinsic muscle training program on functional recovery with Foot Functional Index Scale in patients with plantar fasciitis.

 

RESEARCH QUESTION

Will there be any effect of 4 weeks of plantar intrinsic muscle training program on pain and functional recoveryin patients with plantar fasciitis?

 

Hypotheses

Null Hypothesis (H0): There will be no significant effect of 4 weeks of plantar intrinsic muscle training program on pain and functional recovery in patients with plantar fasciitis.

Alternative Hypothesis (H1): There will be significant effect of 4 weeks of plantar intrinsic muscle training program on pain and functional recovery in patients with plantar fasciitis.

 

 
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