| CTRI Number |
CTRI/2020/05/025414 [Registered on: 28/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2020 |
| 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
|
Effect of Gua Sha and Cyrostretch techniques on Plantar fasciitis |
|
Scientific Title of Study
|
Effect of Gua Sha v/s Cryostretch technique on pain and function 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 |
Dr Peeyoosha Gurudut |
| Designation |
Associate professor, Department of Orthopaedic Physiotherapy, KIPT. |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Department of Orthopaedic Physiotherapy, KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
0831-247427 |
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Associate professor, Department of Orthopaedic Physiotherapy, KIPT. |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Department of Orthopaedic Physiotherapy, KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Jadhav |
| Designation |
Bpt |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Department of Orthopaedic Physiotherapy, KlE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belgaum
Anand Smruti , Behind Patteds Hospital, Ayodhya Nagar, Belagavi.
Belgaum
KARNATAKA
590006
India |
| Phone |
09172840088 |
| Fax |
|
| Email |
aditijadhav1115@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Aditi Jadhav |
| Address |
KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belgaum |
| 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 Peeyoosha Gurudut |
KLE Institute of Physiotherapy |
KLE Institute of
Physiotherapy, JNMC
campus Nehru Nagar,
Belgaum
Belgaum
KARNATAKA |
9844821355
peeoo123@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee, KLEU Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M624||Contracture of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
1) Interferential therapy- 7 days along with other interventions for 15 mins.
2) Plantar fasciitis exercises |
| Intervention |
Gua sha technique and Cyrostretch technique |
Gua Sha technique- Only on first day of intervention for 15 mins(1 week intervention)
Cryostretch technique- 30 reps on 1st, 3rd and 5th day of the week(1 week intervention) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of any one of the following criteria:
Painful first step in morning.
Calcaneal soreness on palpation.
Pain on palpation along the proximal plantar fascia.
|
|
| 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. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale
Foot function index |
Baseline and post 1 week of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure algometer |
Baseline and post 1 week of 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/05/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of my study is to study and compare the effectiveness of gua sha and cyrostretch technique on subjects with plantar fascitis. There will be 40 participants divided into two groups of 20 subjects in each group. They will recieve the treatment with other conservative treatment for plantar fasciitis. |