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
|
|
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
|
|
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. |