| CTRI Number |
CTRI/2025/02/080266 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| 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
|
to observe and compare the effect of foam rolling and Instrument assistant soft tissue mobilization in patients with acute Plantar Fascities |
|
Scientific Title of Study
|
To compare effect of foam rolling versus Instrument assistant soft tissue mobilization in patients with acutre Plantar Fascities |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanket Parekh |
| Designation |
Assistant professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept no 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Savle |
| Designation |
PG student |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept no 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
shivanisavle110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Parekh |
| Designation |
Assistant professor |
| Affiliation |
k m Patel Institute of Physiotherapy |
| Address |
Dept no 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad
GUJARAT
388325
India |
| Phone |
09879352362 |
| Fax |
|
| Email |
sanketkp@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| K M Patel Institute of Physiotherapy Shree Krishna Hospital Gokalnagar Karamsad 388325 Gujarat India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 shivani savle |
K M Patel Institute of Physiotherapy |
Dept No 152 K M Patel Institute of Physiotherapy Shree Krishna Hospital Karamsad 388325 Gujarat India
Anand
GUJARAT |
09913898740
shivanisavle110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -2 Bhaikaka University Karamsad |
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 |
Foam rolling exercises |
For Planter Fascia the Patient were in standing position with the affected foot on foam roller and non affected foot on floor. The Participant were instructed to do back and forth motion from heel to toes of foot on foam roller while exerting pressure on foam roller. Frequency for foam rolling 30 sec hold 3 set. Time Duration 10 min.
Total duration for this session will be 30 mins.
There will be 4 sessions/week for 2 weeks, and 1 week home exercise program and follow up |
| Comparator Agent |
IASTM(instrument assisted soft tissue mobilization) technique along with conventional therapy |
The Graston tools were then used to mobilize the tissues of the plantar foot by passing the tools along the foot. A two-hand hold grip was used to ensure that the instrument require 30-60° angle to the treatment surface, Plantar fascia Soft tissue dysfunctions in the foot was detected using scanner and treated when manually applied brush strokes to the affected area and proceeded to use 2 cycles of 15-20 series of strokes one cycle of stokes in proximal to distal direction and vice versa over the area. During application one end of the instrument was stabilized, serving as a fulcrum of motion while the other end is moving, with the resistance at the end of the instrument that is moving. Force was directed deep enough to detect increased tissue restriction Duration will be 10 min. Total duration for this session will be 25 – 30 min.
There will be 4 sessions/week for 2 weeks, intervention and home exercise program for 1 week, and follow up |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
25 to 60 years age group
Gender Male and Female both
Presence of Unilateral or Bilateral Planter Fasciitis |
|
| ExclusionCriteria |
| Details |
Reported previous history of cancer, peripheral vascular diseases, lower extremity fractures Rheumatoid arthritis (or) osteoporosis.
Had a trauma or history of surgery to the foot or ankle.
Presence of skin infection
Diabetic neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS - Pain |
pre assessment before intervention
Post intervention that is after 2 weeks of intervention
follow up that is after 3 weeks after completing intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| foot function index |
pre assessment before intervention
Post intervention that is after 2 weeks of intervention
follow up that is after 3 weeks after completing intervention |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
17/02/2025 |
| 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 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
|
Several exercises are done to treat the affected fascia. Other instrumentation are also used like Foam rolling and IASTM both techniques are effective for reducing pain and functional activity in Planter fasciitis. This both techniques are for releasing fascia which getting tight in planter fasciitis. So we took up this study by comparing this two technique we get to know which technique is better. |