CTRI Number |
CTRI/2023/03/050561 [Registered on: 10/03/2023] Trial Registered Prospectively |
Last Modified On: |
01/03/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Other |
Public Title of Study
|
Comparative study of two instrumental release on upper trapezitis- an experiemental study |
Scientific Title of Study
|
Effectiveness of Gua Sha Therapy versus Graston Release Technique among subjects with acute Trapezitis - a comparative study |
Trial Acronym |
|
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 |
Vice Principal & HOD |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC
Belgaum KARNATAKA 590010 India |
Phone |
9845271899 |
Fax |
|
Email |
vijaykage@yahoo.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vijay Kage |
Designation |
Vice Principal & HOD |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC Belgaum KARNATAKA 590010 India |
Phone |
9845271899 |
Fax |
|
Email |
vijaykage@yahoo.in |
|
Details of Contact Person Public Query
|
Name |
Sanket Amonker |
Designation |
Physiotherapy Intern |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC Belgaum KARNATAKA 590010 India |
Phone |
9922423828 |
Fax |
|
Email |
snkt.amonker@gmail.com |
|
Source of Monetary or Material Support
|
KLE Dr. Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi 590010 |
|
Primary Sponsor
|
Name |
Anuradha Paramshetti |
Address |
Advanced Physiotherapy Centre, Room no-39, Sagar Floor, KLE Dr. Prabhakar Kore Hospital and MRC |
Type of Sponsor |
Other [] |
|
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 |
Anuradha Paramshetti |
KLE Dr. Prabhakar Kore Hospital and MRC |
Advanced Physiotherapy No.39,
Orthopedic department room no.18 Belgaum KARNATAKA |
9686348038
anuradha.paramshetti@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Research and Ethical Comittee, KAHER Institute of Physiotherapy |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
trapezitis |
Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Graston release technique |
Graston release strokes for upper trapezius muscle 10 strokes at an angle of 45 degree on every alternate day for a week. |
Intervention |
Gua Sha Therapy |
Upper trapezius muscle 10 strokes will be given at an angle of 45 degrees on every alternate day for a week. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Individuals having mechanical neck pain
VAS score of more than 4
CVA angle: < than 48.8 degrees for males.
< than 47.6 degrees for females.
Acute upper trapezitis. |
|
ExclusionCriteria |
Details |
Any trauma around the neck and upper back
Open wounds around upper back
Surgery performed in last 6 months in cervical region
Primary carcinoma or metastasis present in the posterior neck or upper back
History of pulmonary embolism, thrombosis and venous deficiency
Skin rash and other skin condition
Diabetes mellitus |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
PAIN PRESSURE ALGOMETER
CVA ON PROCTRACTOR APP |
The subject will be assesed on the 1st day of the treatment i.e at the beginning of treatment and 5th day of treatment i.e last day of treatment |
|
Secondary Outcome
|
Outcome |
TimePoints |
UNIVERSAL GONIOMETER |
The subject will be assesed on the 1st day of the treatment i.e at the beginning of treatment and 5th day of treatment i.e last day of treatment |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
15/03/2023 |
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
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
We will be doing a comparative study of two techniques which is Gua Sha therapy and Graston release technique on upper trapezitis. The subjects will be divided into two groups equally on the basis of inclusion and exclusion criteria, and will be assesed pre treatment. Each group will be given one technique only along with conventional therapy which will be common to both the groups. Treatment will be given for a week on alternate days and will be assesed post treatment on the last day. |