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CTRI Number  CTRI/2025/04/085958 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
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   Comparing the Effect of Instrument Assisted Soft Tissue Mobilization Versus Self Myofascial Release Technique on Pain and Ankle Dorsiflexion Range in Runners suffering with Plantar Fasciitis  
Scientific Title of Study   A Study on Effectiveness of Instrument Assisted Soft Tissue Mobilization Versus Self-Myofascial Release on Pain and Range of Motion in Runners 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  Bhaskarabatla Sri Kruthi 
Designation  Master of Physiotherapy 
Affiliation  Durgabai Deshmukh College of Physiotherapy 
Address  Durgabai Deshmukh College of Physiotherapy, Osmania University, Adikmet. Department of Sports Medicine, Ground Floor, Therapeutic Gym.

Hyderabad
TELANGANA
500044
India 
Phone  9989667386  
Fax    
Email  srikruthi10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ch Sitaram Babu 
Designation  Professor  
Affiliation  Affiliated to Kaloji Narayana Rao University of Health Sciences (KNRUHS) 
Address  Durgabai Deshmukh College of Physiotherapy, Osmania University, Adikmet. Affiliated to KNRUHS Department of Sports Medicine, Ground Floor, Therapeutic Gym.

Hyderabad
TELANGANA
500044
India 
Phone  93968 68237  
Fax    
Email  physioram@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Bhaskarabatla Sri Kruthi 
Designation  Master of Physiotherapy 
Affiliation  Affiliated to Kaloji Narayana Rao University of Health Sciences (KNRUHS) 
Address  Durgabai Deshmukh College of Physiotherapy, Osmania University, Adikmet. Affiliated to KNRUHS Department of Sports Medicine, Ground Floor, Therapeutic Gym.

Hyderabad
TELANGANA
500044
India 
Phone  9989667386  
Fax    
Email  srikruthi10@gmail.com  
 
Source of Monetary or Material Support  
Durgabai Deshmukh College of Physiotherap Osmania University, Adikmet. Department of Sports Medicine, Ground Floor, Therapeutic Gym. 
 
Primary Sponsor  
Name  Self 
Address  Durgabai Deshmukh College of Physiotherapy, Osmania University, Adikmet - 500044 Department of Sports Medicine, Ground Floor, Therapeutic Gym. 
Type of Sponsor  Research institution and hospital 
 
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 
Bhaskarabatla Sri Kruthi  L B Stadium  L B Stadium, Nampally, Hyderabad, Telangana - 500001 Department of Physiotherapy, Ground Floor, Physiotherapy Room..
Hyderabad
TELANGANA 
09989667386

srikruthi10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Durgabai Deshmukh Hospital and Research Centre  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 
Intervention  Instrument Assisted Soft Tissue Mobilization Technique  Active Range of Motion Exercises of Ankle, Calf Stretching Exercises for 3 repetitions and Instrument Assisted Soft Tissue Mobilization technique for Calf and Plantar Fascia includes different kinds of strokes like scanning stroke, sweep stroke, fanning stroke. Each stroke is applied in 2 cycles of 15-20 times of each stroke. Each participant receives 10 minutes of treatment. 
Comparator Agent  Self-Myofascial Release Technique  Active Range of Motion Exercises of Ankle, Calf Stretching Exercises for 3 repetitions, Self-Myofascial Release Technique for Calf and Plantar Fascia using Foam Roller. Foam rolling is performed by the participants for 45 seconds followed by a 15 seconds rest with five repetitions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Individuals Who Run for 30 kilometres per week.
2. Individuals Reported Pain with the First Step Out of Bed in the Morning or with the First Step After Prolonged Immobilization or during Running.
3. Presence of Plantar Fasciitis Confirmed by Pain Reproduced on Palpation or Positive Windlass Test or Individuals Diagnosed with Plantar Fasciitis by an Orthopedician.
4. Runnners having Decreased Ankle Dorsiflexion Range Measured by Weight Bearing Lunge Test (less than 9 centimetres).
5. Individuals with Pain of less than 7 on Numerical Pain Rating Scale of 0-10 Score. 
 
ExclusionCriteria 
Details  1. Individuals who Run for less than 30 kilometres per week.
2. History of any Major Injury or Surgery in the Lower Extremity.
3.No other acute Knee, Ankle and Foot Pathology.
4. Individuals on Long-term Anti-coagulants and Steroids.
5. Previous History of Neuropathy of Lower Extremity.
6. Individuals with Foot or Heel Trauma,
soft Tissue Injuries, Skin Ulceration (Infection or Wound).
7. Lack of Consent to Participate in the Study. 
 
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, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale-10  2 Time Points: Baseline and 4 weeks of Post-Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Weight Bearing Lunge Test  2 Time Points: Baseline and 4 weeks of Post-Intervention 
 
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)   28/05/2025 
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)   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 is caused due to inflammation of plantar fascia at its insertion on the calcaneal tubercle due to overstressing of the fascia, also referred as plantar heel pain. There is high prevalence of plantar fasciitis in runners is due to force absorption associated with running. The sample includes 40 runners and will be divided into two groups, one group will receive Instrument Assisted Soft Tissue Mobilization technique and the other group will receive Self-Myofascial Release technique. Outcome measures include Numerical Pain Rating Scale to assess pain and Weight Bearing Lunge Test to assess ankle dorsiflexion range. 
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