| CTRI Number |
CTRI/2022/10/046574 [Registered on: 18/10/2022] Trial Registered Prospectively |
| Last Modified On: |
09/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study on the effectiveness of cryo massage and kneading on para spinal muscle spasm. |
|
Scientific Title of Study
|
A comparative study on the efficacy of cryo massage and kneading on para spinal muscle spasm. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JENI PATEL |
| Designation |
PG STUDENT |
| Affiliation |
Swarrnim Startup and Innovation University |
| Address |
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Gandhinagar
GUJARAT
382420
India |
| Phone |
7041110020 |
| Fax |
|
| Email |
jenipatel27.jp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind kumar |
| Designation |
Principal, Professor & PG Guide |
| Affiliation |
Swarrnim Startup and Innovation University |
| Address |
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Gandhinagar
GUJARAT
382420
India |
| Phone |
9784631151 |
| Fax |
|
| Email |
principal.physio@swarrnim.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
JENI PATEL |
| Designation |
PG STUDENT |
| Affiliation |
Swarrnim Startup and Innovation University |
| Address |
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Gandhinagar
GUJARAT
382420
India |
| Phone |
7041110020 |
| Fax |
|
| Email |
jenipatel27.jp@gmail.com |
|
|
Source of Monetary or Material Support
|
| VENUS INSTITUTE OF PHYSIOTHERAPY - SWARRNIM STARTUP & INNOVATION UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Arvind |
JENI PATEL |
Bhoyan Rathod, Opposite IFFCO, Near ONGC WSS, Adalaj Kalol Highway, Gandhinagar, Gujarat - 382420.
Gandhinagar
GUJARAT |
07041110020
jenipatel27.jp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Venus Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional |
Home advice is prescribed for intervention group. |
| Comparator Agent |
cryo massage |
For the study 20 subjects will be selected to full- fill the inclusion criteria. subjective evaluation of the subjects is to be carried out by assessment. Out of 20 subjects,10 subjects will receive cryo massage. |
| Comparator Agent |
Kneading |
For the study 20 subjects will be selected to full- fill the inclusion criteria. subjective evaluation of the subjects is to be carried out by assessment. Out of 20 subjects,10 subjects will receive kneading. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
Subjects with para spinal muscle spasm.
Age group 20 to 40 years.
The subjects having pain with vas score of more than 4 are to be included in the study.
Patient should be willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
• Presence of neurological condition or disorder of whole spine.
• Open wounds and skin infection over para spinal muscle.
• Patient’s other than the prescribed age limit
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vas score |
pretreatment and post treatment (after 15 days outcome will be assessed) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS Scale |
pretreatment and post treatment (after 15 days outcome will be assessed) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/11/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will compare the effect of cryo massage and kneading in the para spinal muscle spasm. There will be two groups, half of study group will receive cryo massage and half of study group will receive kneading technique. hypothesis of the study is there will be significant difference between the effect of cryo massage and kneading technique on para spinal muscle spasm. Null hypothesis of the study is there is no significant difference between the effect of cryo massage and kneading technique on para spinal muscle spasm. |