| CTRI Number |
CTRI/2024/04/065070 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
EFFECTIVENESS OF DRY CUPPING WITH EXERCISES ON FORWARD HEAD POSTURE |
|
Scientific Title of Study
|
Efficacy of dry cupping with exercises on forward head posture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravinder kumar |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9817226881 |
| Fax |
|
| Email |
dararavinder6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravinder kumar BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
HISAR,HARYANA |
| Type of Sponsor |
Research institution |
|
|
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 Ravinder kumar |
Guru Jambheshwar University of Science and Technology |
Room no .5 OPD
Department of physiotherapy Guru Jambheshwar university of Science and Technology Hisar
Hisar
HARYANA |
9817226881
dararavinder6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of dry cupping with exercises on forward head posture |
In this group patients will perform only exercises 3 times per week for 6 weeks and then all measurements will be taken |
| Intervention |
Efficacy of dry cupping with exercises on forward head posture |
Patient in this group will perform exercises with dry cupping .Dry cupping once per week and exercises 3 session per week for total 6 weeks .All measurements will be taken at basement after 3 weeks and after 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients of neck pain with forward head posture |
|
| ExclusionCriteria |
| Details |
1. Orthopedic conditions like fracture ,acute neck injury etc.
2. Already had participated in regular exercise program.
3. Uncooperated subject.
4. Neurological problems like peripheral neuropathy,stroke etc.
5. Being older than 30 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.CVA
2.VAS
2.NDI
4.Cervical ROM
5.OVERALL PHYSICAL AND MENTAL STATUS
|
The outcome will be measured for three times which is
1.At baseline
2 After three weeks and
3.After six weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CVA
2. NDI
3. VAS
4. CERVICAL ROM
5. OVERALL PHYSICAL AND
MENTAL HEALTH STATUS
4 . PHYSICAL AND MENTAL STATUS (DUE TO FHP) |
MEASUREMENT WILL BE TAKEN AT
1. AT BASELINE
2. AFTER 3 WEEKS
3. AFTER SIX WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
10/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/09/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
It is a randomized control trial with a duration of 6 weeks and involving 62 patients that will be divided into 2 groups based on lottery method . Its intervention involves dry cupping with exercises on first group and exercise on other group .The patients will be informed about the study and written consent will be taken . First patient data collected from baseline then after three weeks and post intervention will be taken after 6 weeks . Data involves CVA, Cervical ROM ,VAS , NDI, and Physical and mental health status. These data will be collected at baseline ,after 3 weeks and after 6 weeks . CVA angle will be measured before and after the treatment protocol. |