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CTRI Number  CTRI/2024/07/070310 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 17/06/2024
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   A trial to study the effect of Integrated Neuromuscular Inhibition Technique (INIT) on daily function and balance in patients with heel pain 
Scientific Title of Study   The Effect of Integrated Neuromuscular Inhibition Technique on Functional Performance and Balance in Subjects with Plantar Fasciitis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiandra Clare Fernandes 
Designation  PG student 
Affiliation  St. Johns Medical College  
Address  Room No. 30, Department of Physiotherapy, St. Johns Medical College Hospital, Sarjapur Marathahalli Road, John Nagar, Koramangala Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  8197047126  
Fax    
Email  kiandra.fernandes@stjohns.in  
 
Details of Contact Person
Scientific Query  
Name  Sneha Vishwanath 
Designation  Associate Professor 
Affiliation  St. Johns Medical College Hospital 
Address  Room No. 30, Department of Physiotherapy, St. Johns Medical College Hospital, Sarjapur Marathahalli Road, John Nagar, Koramangala Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9739314175  
Fax    
Email  snehapt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sneha Vishwanath 
Designation  Associate Professor 
Affiliation  St. Johns Medical College Hospital 
Address  Room No. 30, Department of Physiotherapy, St. Johns Medical College Hospital, Sarjapur Marathahalli Road, John Nagar, Koramangala Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9739314175  
Fax    
Email  snehapt@gmail.com  
 
Source of Monetary or Material Support  
St. Johns Medical College Hospital, Sarjapur Marathahalli Road, John Nagar, Koramangala Bengaluru 560034, India 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Dr Sneha Vishwanath  St. Johns Medical College Hospital  Room No. 30, Department of Physiotherapy, St. Johns Medical College Hospital, Sarjapur Marathahalli Road, John Nagar, Koramangala Bengaluru
Bangalore
KARNATAKA 		 9739314175

snehapt@gmai.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituional Ethics Committee St. Johns Medical College  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 
Comparator Agent  Conventional Treatment  Conventional treatment involves plantar fascia and calf stretches for 30 seconds hold for 3 repetitions each. Followed by strengthening exercises i.e., standing toe curls, heel raises and towel toe curls – 10 repetitions for 3 sets. The last phase of conventional treatment involves phonophoresis over the heel using ketoprofen 2.5% w/w gel with settings of 1.5 w/cm2 frequency on continuous mode at 3 MHz for 5 minutes. A total of 6 sessions will be conducted, 3 sessions per week over the course of 2 weeks.  
Intervention  Integrated Neuromuscular Inhibition Technique  Integrated Neuromuscular Inhibition Technique (INIT) is a combined comprehensive approach involving Ischemic Compression (IC) which involves sustained compression to the trigger points for 30-90 seconds; followed by Strain Counterstrain (SCS) wherein the ankle is plantarflexed while palpating the trigger point for 90 seconds until symptomatic relief is felt. The last component is Muscle Energy Technique (MET) which produces muscle relaxation through isometric contraction of the gastrocnemius and soleus muscles in their lengthened state for 5-7 seconds with a period of relaxation of 5 seconds, repeated as 5 sets. A total of 6 sessions will be conducted, 3 sessions per week over the course of 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Progressive onset of heel pain lasting for more than 1 month localized to the medial aspect of the heel
Positive Windlass test
Increase in pain in the morning on taking first few steps or after prolonged non weight bearing
NPRS more than or equal to 5 on 10 
 
ExclusionCriteria 
Details  Red flags to manual therapy i.e., tumors, rheumatoid arthritis, osteoporosis, severe vascular disease, active tuberculosis, etc.
Corticosteroid injections taken for plantar fasciitis within the last 6 months
Previous physiotherapy treatment for plantar fasciitis within the last 1 month
History of foot and/or ankle trauma/fracture in the last 1 year
Referred pain due to sciatica or other neurological disorders
Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Functional Performance using Foot Function Index - Revised questionnaire   Baseline (Day 1) and Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Balance, Ankle Joint Proprioception, Ankle Range of Motion  Baseline and Day 6 
Pain  Baseline, Day 3, Day 6 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2025 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The plantar fascia is considered a degenerative condition which develops due to repeated biomechanical stress and microtrauma over the fascia. Those suffering from plantar fasciitis experience an insidious onset of sharp pain over the inferomedial aspect of the heel which radiates into the arch of the foot. This pain is most intensified during the first step in the morning after the foot has been in a status of non-weight bearing for a long duration. Studies have also indicated that muscle trigger points within gastrocnemius muscle, abductor digiti minimi and flexor digitorum brevis can lead to the development of heel pain. Patients with plantar fasciitis employ compensatory mechanisms to reduce the discomfort from the plantar fascia. These strategies alter the joint position sense and muscle activation which make it difficult to maintain an upright posture within the base of support which can impair both static and dynamic balance.
There are several approaches in trigger point release which has been demonstrated; the combined comprehensive approach referred to as Integrated Neuromuscular Inhibition Technique (INIT) includes ischemic compression (IC), strain counter-strain (SCS) and muscle energy techniques (MET). 
The ongoing evolution in research of conservative treatment methods of plantar fasciitis highlights the need to explore methods that offer long-term effectiveness. The study aims to address the gap in literature, examining the combined effect of INIT on plantar fasciitis and contributing valuable insights to the field. 
 
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