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CTRI Number  CTRI/2023/07/054698 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 03/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   effect of ankle joint mobilization along with foot core strengthening to improve functional status in patients with plantar fasciitis: A randomised controlled trial. 
Scientific Title of Study   Effectiveness of subtalar joint mobilization along with Foot core strengthening on pain and functional status in patients with plantar fasciitis: A randomised 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  Ketaki Patil 
Designation  PG student 
Affiliation   
Address  Pravara Institute of Medical Sciences OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY Dr APJ Abdul Kalam College of Physiotherapy TAL RAHATA DIST AHMEDNAGAR LONI MAHARSHTRA 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9970796007  
Fax    
Email  ketakipatil61298@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh K Sinha 
Designation  PROFESSOR AND PRINCIPAL 
Affiliation   
Address  Pravara Institute of Medical Sciences OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY Dr APJ Abdul Kalam College of Physiotherapy TAL RAHATA DIST AHMEDNAGAR LONI MAHARSHTRA 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9799783783  
Fax    
Email  smartphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ketaki Patil 
Designation  PG student 
Affiliation   
Address  Pravara Institute of Medical Sciences OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY Dr APJ Abdul Kalam College of Physiotherapy TAL RAHATA DIST AHMEDNAGAR LONI MAHARSHTRA 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9970796007  
Fax    
Email  ketakipatil61298@gmail.com  
 
Source of Monetary or Material Support  
Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy 
 
Primary Sponsor  
Name  Dr APJ Abdul Kalam College of Physiotherapy 
Address  Pravara Institute of Medical Sciences OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY Dr APJ Abdul Kalam College of Physiotherapy TAL RAHATA DIST AHMEDNAGAR LONI MAHARSHTRA 413736 
Type of Sponsor  Private medical college 
 
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 
KETAKI PATIL  PRAVARA INSTITUTE OF MEDICAL SCIENCES  Dr APJ Abdul Kalam College of Physiotherapy OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY TAL RAHATA DIST AHMEDNAGAR LONI MAHARSHTRA 413736
Ahmadnagar
MAHARASHTRA 
9970796007

ketakipatil61298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee 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: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL THERAPY   THERAPEUTIC ULTRASOUND 50 PERCENT PULSE MODE 1 MHZ FREQUENCY 1.5WATT PER CENTERMETER SQ. INTENSITY STRETCHING EXERCISES FOR FOLLOWING MUSCLES GASTRONEMIUS SOLEUS PLANTAR FASCIA 3 REPETATIONS WITH 30 SECOND HOLD 3 TIMES PER WEEK 
Intervention  Subtalar joint mobilization Foot core strengthening  1.Subtalar joint mobilization 3sets with 6-10sec for 3 times per week 2.Foot core strengthening toe spread out first toe extension second to fifth toe extension short foot exercise 3sec for 4sets with 15repetition 3 times per week  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group 40-60years
Both Male and Female
Patients with positive windlass test
Diagnosed case of plantar fasciitis
Patients with navicular drop 
 
ExclusionCriteria 
Details  History of ankle or foot surgery
Patients with any congenital/acquired deformity of foot
Patients with any neurological condition
Refuse to participate or sign informed consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale
foot function index 
Baseline to 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   13/07/2023 
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="2"
Months="0"
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  

Plantar fasciitis (PF; also known as “plantar heel pain”) is a common foot disorder in adults secondary to an inflammatory response caused by repetitive micro-trauma.(1)a localized inflammation of the plantar aponeurosis, is reported to be the most common cause of heel pain. An estimated 1 in 10 people will develop the condition over a lifetime.(2) Complaint is usually of an insidious sharp pain in the medial heel along the medial plantar fascia at the insertion at the medial tuberosity of the calcaneum on weight bearing after a period of non-weight bearing.(3)Typically, this pain is described as “burning”, “aching” and, occasionally, “lancinating”.(1) The typical pain of PF is located at the hindfoot,(4) medial tubercle of the calcaneus and normally occurs during the first few steps in the morning or after a prolonged non-weight bearing activity.(5) And can often be a challenge for clinicians to treat successfully. It occurs over a wide age range and is seen in both sedentary and athletic individuals.(4,6) PF may affect >1 million people worldwide per year. The exact prevalence of PF is not known. The lifetime prevalence may reach 10% of the general population worldwide. Affect all the age groups, sexes, and ethnicities, with a higher prevalence noted in females aged 40–60 years. (1) There is no clear consensus on the etiology of plantar fasciitis, but overuse due to prolonged weightbearing or unaccustomed activity, obesity, and limited dorsiflexion range of motion have all been implicated as contributing factors.(2)  After the initial inflammatory response and repetitive micro-trauma of plantar aponeurosis, myxoid degeneration with PF fragmentation as well as vascular ectasia in bone marrow, are the most common histologic findings. Therefore, PF may be considered a degenerative fasciosis in the absence of inflammation.(1)  Plantar heel pain also results in mild disability and decrease in quality of life of an individual.(3) . Diagnosis of PF can be made through the patient history, clinical symptoms, and objective assessments such as pain level, palpation, muscle tightness, joint range of motion, or muscle strength. In addition, diagnostic imaging may be used to exclude other causes of pain such as heel spurs or tissue inflammation.(5) . Patients with PF who have painful episodes at the heel commonly avoid weight bearing on the symptomatic foot and are at risk for developing antalgic gait. Patients with PF tend to walk more slowly than healthy individuals in order to avoid or reduce pain. They show significant decreases in cadence, gait speed, stride length, and increases in stride time.(5) Conservative treatments for PF usually include rest, anti-inflammatory drugs, shoe inserts, shoe wear modification, stretching exercises, and physical therapy. Examples of physical therapy are massage, mobilization, therapeutic ultrasound, and taping.(5)

 One of the reasons of heel pain may be due to Subtalar joint dysfunction that will affect the movement of calcaneus and thus potentially affect the tension in plantar fascia.(3) Subtalar joint mobilization is a manual therapy intervention that increases the mobility of the calcaneum that contributes an increased pronation and thus increased tensile stress through the plantar fascia.(7) Studies have shown substantial benefit from manual therapy on conditions like Osteoarthritis knee, neck pain, and cervicogenic headaches. There exists less evidence to support the use of manual therapy intervention and their effectiveness in subjects diagnosed with PF.(3,8)

The foot is a highly complex structure with many articulations and multiple degrees of freedom that play an important role in static posture and dynamic activities.(9,10) The foot core system consists of a complex foot structure, including active, passive, and neural subsystems, providing stability and flexibility when coping with changing foot demands.(11) The theoretical basis of lumbopelvic-hip core stability is applied to the foot core system.(12)The passive subsystem of the foot core consists of the bones, ligaments and joint capsules that maintain the various arches of the foot. The active subsystem consists of the muscles and tendons that attach on the foot. The local stabilizers of the foot are the plantar intrinsic muscles that both originate and insert on the foot, whereas the global movers are the extrinsic muscles that originate in the lower leg, cross the ankle and insert on the foot. The neural subsystem consists of the sensory receptors in the plantar fascia, ligaments, joint capsules, muscles and tendons involved in the active and passive subsystems. (9) The intrinsic foot muscles and extrinsic foot muscles, which constitute the foot active subsystem, also play an active role in maintaining foot core stability.

 
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