| CTRI Number |
CTRI/2026/03/106869 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| 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
|
Added effect of sole release with gua sha to conventional physiotherapy on pain, function and lumbopelvic rhythm in non specific low back pain |
|
Scientific Title of Study
|
Added effect of plantar fascia release with gua sha to conventional physiotherapy on pain, function and lumbopelvic rhythm in non specific low back pain: a randomized controlled 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 |
Dr Vijay Kage |
| Designation |
Dean and professor |
| Affiliation |
Kle institute of physiotherapy |
| Address |
Kle institute of physiotherapy
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Dean and professor |
| Affiliation |
Kle institute of physiotherapy |
| Address |
Kle institute of physiotherapy
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kage |
| Designation |
Dean and professor |
| Affiliation |
Kle institute of physiotherapy |
| Address |
Kle institute of physiotherapy
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore hospital, Nehrunagar Belagavi, Karnataka, India-590010 |
|
|
Primary Sponsor
|
| Name |
avantika dixit |
| Address |
kle institute of physiotherapy, nehru nagar, belagavi- 590010 |
| 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 |
| Avantika dixit |
KLEs Dr. Prabhakar Kore Hospital |
Room no. 39, physiotherapy OPD
Belgaum
KARNATAKA |
9518965520
avantikasdixit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy for low back pain |
standardised protocol for low back pain along with electrotherapeutic modalities like interferential current along with exercises for 3 days per week for 3 weeks lasting 50 minutes per session |
| Intervention |
Gua sha assisted plantar fascia release added with conventional physiotherapy |
intervention is 3 days per week with fascia release once a week for 3 weeks each session lasting for 50 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Chronic cases of non specific low back pain
VAS score more than 3
V sit and reach score in negative |
|
| ExclusionCriteria |
| Details |
Skin lesions or ulcers and open wounds over ankle or foot
Diagnosed case of heel pain, malignancy, epilepsy
Recent fractures
Pathologies related to peripheral nerves
Diabetic neuropathy
Metal implants in low back region
Specific causes of low back pain
Disc pathologies
Pregnancy
Obesity |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
At baseline
And then at 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Oswestry Disability Index |
At baseline
And then at 3 weeks |
| V sit & reach test |
At baseline
And then at 3 weeks |
| Modified modified schober’s test |
At baseline
And then at 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/04/2026 |
| 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
|
After obtaining ethical clearance, CTRI registration will be completed Participants will be recruited after screening and inclusion and exclusion criteria will be applied A written informed consent in participant’s vernacular language will be obtained Pre assessments will be done and recorded Experimental group will receive gua sha assisted plantar fascia release in addition to conventional physiotherapy Control group will receive conventional physiotherapy Intervention will be carried out for 3 weeks Post assessment will be done and recorded Statistician will be consulted and results will be drawn
|