| CTRI Number |
CTRI/2023/09/057420 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effects of tool-based soft tissue mobilization and deep friction massage on pain and function in patients with plantar heel pain |
|
Scientific Title of Study
|
Effects of instrument-assisted soft tissue mobilization and deep friction massage on pain and function in patients with plantar heel pain: A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Agrawal |
| Designation |
Post graduate student |
| Affiliation |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy |
| Address |
First floor, department of musculoskeletal physiotherapy Sancheti institute for orthopaedics and rehabilitation college of physiotherapy thube park shivaji nagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9834150525 |
| Fax |
|
| Email |
harshitaagrawal192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sona Kolke PT |
| Designation |
Associate Professor |
| Affiliation |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy |
| Address |
First floor department of musculoskeletal physiotherapy at Sancheti institute for orthopaedics and rehabilitation college of physiotherapy thube park shivaji nagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sona Kolke PT |
| Designation |
Associate Professor |
| Affiliation |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy |
| Address |
First floor department of musculoskeletal physiotherapy at Sancheti institute for orthopaedics and rehabilitation college of physiotherapy thube park shivaji nagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| 11/12 Sancheti institute for orthopaedics and rehabilitation college of physiotherapy near thube park shivaji nagar pune |
|
|
Primary Sponsor
|
| Name |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy |
| Address |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy 11/12 thube park shivaji nagar Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Harshita Agrawal |
Sancheti institute for orthopaedics and rehabilitation college of physiotherapy |
First floor department of musculoskeletal physiotherapy at Sancheti institute for orthopaedics and rehabilitation college of physiotherapy thube park shivaji nagar Pune
Pune
MAHARASHTRA |
9834150525
harshitaagrawal192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti institute for orthopaedics and rehabilitation college of physiotherapy Institutional Ethical Committee |
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 |
| Comparator Agent |
Deep friction massage |
Deep friction to the plantar fascia will be applied using the thumb, the heel of the hand, or the index finger supported by the middle finger or the middle finger with two adjacent fingers supporting it provides the application of concentrated, repetitive
stroking or sweeping.
The sweeps are directed perpendicular to the fiber orientation of the
fibers of the plantar fascia in small to-and-fro sweeps in one particular
direction only.
Sufficient initial treatment will be applied till a point where analgesia
for approximately 2 – 3 mins and the response to the treatment will be
noted.
With the subsequent treatment sessions pressure applied will be advanced, total treatment duration will be approximately 4- 5 mins |
| Intervention |
Instrument-assisted soft tissue mobilization |
The initial scanning technique using the sharp edge of the Edge
Mobility Tool at an angle of 30 degrees to the surface will be done with
a sweeping motion in the proximal to distal direction with light
pressure.
The identification of the restrictions of superficial and deep fascia will
be based on the distinct vibrations felt and will guide the therapist to the
specific area in need of the treatment.
After the identified restrictions, using the beveled edge of the tool - at
30 - 60 degrees - a strumming technique will be used to break the
adhesions for 40 to 120 seconds (as per need) per restriction.total duration of intervention is 2 mins |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients of either gender, within the age group of 25 to 55 years.
b.Patients diagnosed with plantar fasciitis and with a positive windlass test.
c.Plantar heel pain with a VAS score between 4 and 8.
|
|
| ExclusionCriteria |
| Details |
a. Patients with ankle trauma
b. Any lower extremity surgery
c. Ankle ligament sprains.
d. Peripheral nerve injuries in lower limb
e. Ankle arthritis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain pressure algometer
Foot & ankle disability index |
At baseline & 3 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
At baseline & 3 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 aim of the study is to compare the effects of Instrument-assisted soft tissue mobilization and deep
friction massage on pain and function in patients with plantar heel pain. The need for the study is as follows manual therapy in terms of soft tissue mobilization is effective in reducing pain
and function in plantar heel pain. Instrument-assisted soft tissue mobilization
(IASTM) is a novel technique for connective tissue remodeling and repair that
can be effectively used to treat plantar heel pain which has effects that are
similar to deep friction massage (DFM); however, IASTM has the added
advantage of penetrating better depth at target tissue and is ergonomically
efficient. In the literature, there has been limited evidence for comparing the
efficacy of IASTM and deep friction massage in patients with Plantar heel
pain. There is also paucity in the literature on its effectiveness in the Indian
population. Thus the current study compares the effects of IASTM
and DFM on pain and function in patients with plantar heel pain.
The hypothesis for the current study is IASTM and DFM will have comparable effects on pain and function in patients
with plantar heel pain.
|