| 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
|
|
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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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
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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
|
|
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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
|
|
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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. | | |