| CTRI Number |
CTRI/2024/10/075878 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| 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
|
Comparison between Instrument assisted soft tissue mobilization and Stretching in patients of plantar fasciitis for pain, function and activities of daily living |
|
Scientific Title of Study
|
To Compare The Effectiveness of IASTM (Instrument Assisted Soft Tissue Mobilization)along with Conventional Physiotherapy Versus Stretching along with Conventional Physiotherapy on Pain,Function and Activities Of Daily Living in Plantar Fasciitis Patients: A Comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Jadon |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9638178232 |
| Fax |
|
| Email |
priyanka2010@mgumst.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hemendra Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopaedics physiotherapy lab, Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9460888177 |
| Fax |
|
| Email |
drhksharma@mgumst.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Hemendra Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Orthopaedics physiotherapy lab, Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9460888177 |
| Fax |
|
| Email |
drhksharma@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road, Jaipur, Rajasthan (India),302022 |
|
|
Primary Sponsor
|
| Name |
Priyanka Jadon |
| Address |
F-48, Jagdamba Nagar F,near Shiv Shakti Mandir, Dhawas, Jaipur, Rajasthan,India,302021 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Hemendra Kumar Sharma |
Mahatma Gandhi Hospital |
Room number 14, Physiotherapy Out Patient Department, Basement. Jaipur RAJASTHAN |
9460888177
drhksharma@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Mahatma Gandhi Medical College and Hospital,MGUMST,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy |
This will be a 2 weeks study.6 days /week,the study will run.The patient will do 5-minute warm-up exercise to warm-up the tissues(Prior to IASTM ).Each participant will then receive 2 minutes of IASTM (Instrument assisted soft tissue mobilization) over each area of restriction using Edge mobility tool after scanning the area. Cream/lubricant will be applied on calf and plantar region of foot as it will assist in reducing friction on skin and then the Edge mobility tool will be used in mobilizing the tissues on triceps surae (gastrocnemius and soleus) and plantar region of foot by pressing the tool along the leg and the foot. Ice will be offered after each session for pain management (as needed).
Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.
The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each. |
| Comparator Agent |
Stretching along with conventional physiotherapy |
For 2 weeks, 6 days/week this will go on.
Gastrocnemius muscle stretch: 3 repetitions for 30 sec hold .
The patient will lie prone with the feet extended off at the end of the examination table so that the knee remains straight as the examiner applies firm pressure to the ball of the foot to take up slack while dorsiflexing the foot at the ankle.
Soleus muscle stretch: 3 repetitions for 30 sec hold .
The patient will lie prone with the knee flexed and the ankle passively dorsiflexed. Increased pressure is gradually applied to dorsiflex the foot fully.
The stretching for each muscle gastrocnemius and soleus will be held with moderate pressure to feel stretch pressure without causing any stretch pain.
Plantar Fascia Stretch: 3 repetitions for 30 sec hold
Position of the subject will be sitting with affected leg cross over the contralateral leg .Technique is while using the hand on the affected side, the fingers will be placed across the base of the toes on the bottom of the foot and pull the toes back toward the shin until they feel a stretch in the arch of the foot. This will confirm that the stretching is correct by palpating the tension in the plantar fascia with the contralateral hand while performing the stretching.
Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.
The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Males and females between age group 30-50 years,
Subjects having pain for more than 3 months over the heel,
Pain with first steps upon walking (greater than or equal to 3 on a 0 to 10 VAS scale),
Pain that is worse in the morning during the initial steps, but which decreases after walking continues. |
|
| ExclusionCriteria |
| Details |
Persons who are undergoing corticosteroids injection, receiving plantar non- steroidal anti- inflammatory medications within the previous 3 week,
Any known radiating pain (lower limb),
Any other lower extremity injury during the previous 6 months,
Currently engaging in any Physical therapy within previous 1 week ,
Calcaneal fracture |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale
Foot and Ankle Ability Measure - Activities of Daily Living Subscale
Foot Function Index - Pain Subscale |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
1 week |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
40 participants will be randomly divided into two groups. In Group A: All 20 patients will be treated with Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy and in Group B: All 20 patients will be treated with stretching along with conventional physiotherapy. All participants will be assessed for plantar fasciitis pain, function and activities of daily living with a Visual Analogue Scale (VAS) , Foot Function Index Pain Subscale (FFI) and the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale . The study will be of 2 weeks. 6 sessions will be taken in a week for both the groups. All variables will be measured at baseline, at the end of 1st week and at the end of 2nd week of the study. . Group A (Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy)
The patient will do 5-minute warm-up exercise to warm-up the tissues(Prior to IASTM ).Each participant will then receive 2 minutes of IASTM (Instrument assisted soft tissue mobilization) over each area of restriction using Edge mobility tool after scanning the area. Cream/lubricant will be applied on calf and plantar region of foot as it will assist in reducing friction on skin and then the Edge mobility tool will be used in mobilizing the tissues on triceps surae (gastrocnemius and soleus) and plantar region of foot by pressing the tool along the leg and the foot. Ice will be offered after each session for pain management (as needed) .
Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.
The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each.
Group B (Stretching along with conventional physiotherapy)
Gastrocnemius muscle stretch: 3 repetitions for 30 sec hold The patient will lie prone with the feet extended off at the end of the examination table so that the knee remains straight as the examiner applies firm pressure to the ball of the foot to take up slack while dorsiflexing the foot at the ankle.
Soleus muscle stretch: 3 repetitions for 30 sec hold The patient will lie prone with the knee flexed and the ankle passively dorsiflexed. Increased pressure is gradually applied to dorsiflex the foot fully. The stretching for each muscle gastrocnemius and soleus will be held with moderate pressure to feel stretch pressure without causing any stretch pain.
Plantar Fascia Stretch: 3 repetitions for 30 sec hold Position of the subject will be sitting with affected leg cross over the contralateral leg .Technique is while using the hand on the affected side, the fingers will be placed across the base of the toes on the bottom of the foot and pull the toes back toward the shin until they feel a stretch in the arch of the foot. This will confirm that the stretching is correct by palpating the tension in the plantar fascia with the contralateral hand while performing the stretching.
Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.
The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each. |