| CTRI Number |
CTRI/2020/10/028591 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
10/04/2021 |
| 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 Of Gua Sha, Cryostretch And Positional Release Technique In Subjects With Plantar Fasciitis
|
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Scientific Title of Study
|
To Study And Compare The Effectiveness Of Gua Sha, Cryostretch And Positional Release Technique On Pain And Function In Subjects With Plantar Fasciitis: A Randomised Clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Peeyoosha Gurudat |
| Designation |
Associate Professor, KAHER Institute of Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Department of Orthopaedic Physiotherapy, KAHER Institute Of Physiotherapy Nehru Nagar, Belagavi,
Karnataka. KAHER Institute Of Physiotherapy Nehru Nagar,
Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha Gurudat |
| Designation |
Associate Professor, KAHER Institute of Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Department of Orthopaedic Physiotherapy, KAHER Institute Of Physiotherapy Nehru Nagar, Belagavi,
Karnataka. KAHER Institute Of Physiotherapy Nehru Nagar,
Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Jadhav |
| Designation |
MPT Student, KAHER Institute of Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Department of Orthopaedic Physiotherapy, KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
09172840088 |
| Fax |
|
| Email |
aditijadhav1115@gmail.com |
|
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Source of Monetary or Material Support
|
| KLES Dr.Prabhakar Kore Hospital And Research Centre Nehru Nagar Belagavi Karnataka. |
|
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Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy Nehru Nagar, Belagavi,
Karnataka. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Peeyoosha Gurudat |
Peeyoosha Gurudut |
Department of Orthopaedic Physiotherapy,KAHER Institute Of Physiotherapy, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA |
9844821355
peeyoo123@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethical Committee KAHER Institute Of Physiotherapy |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cryostretch Technique |
This technique will be administered for alternate days i.e the 1st, 3rd, and 5th day of the week along with exercises.
Pre and post test results will be assessed on the 7th day. |
| Intervention |
Gua Sha Technique |
There will be sequential press stroking along the orientation of the fascia for 15 minutes.
This technique will be administered once i.e on the first day of the intervention. Remaining 6 days will be continued with the exercises. |
| Comparator Agent |
Positional Release Technique |
The pressure and the position is held for 90 secs with 3 repetitions.
The subjects will receive this treatment for 7 sessions over a period of 7 days along with the exercises. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of all genders clinically diagnosed with plantar fasciitis between the age group of 20-60 years
Presence of any one of the following criteria:
Painful first step in morning
Calcaneal soreness on palpation
Pain on palpation along the proximal plantar fascia1
Subjects willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Subjects with recent history of fracture or surgery in and around the ankle joint
Congenital deformity of foot
Subjects with open wounds, infections
Bone malignancy
Sensory impairment
Skin hypersensitivity |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale
Foot function scale |
Baseline and post 1 week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure algometer |
Baseline and post 1 week of intervention |
|
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Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/10/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The aim of this study is to compare the effectiveness of Gua Sha, Cryostretch and Positional release technique in subjects with Plantar fasciitis in terms of pain intensity, pain threshold and function. The ethical clearance is obtained from institutional ethical committee. Group 1 will receive Gua Sha Technique along with other exercises. Group 2 will receive Cryostretch Technique along with other exercises. Group 3 will receive Positional release Technique along with other exercises. Statistical analysis will be done using appropriate software. |