| CTRI Number |
CTRI/2024/11/076471 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| 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
|
Efficacy of MET and static stretching with conventional physiotherapy in neck pain |
|
Scientific Title of Study
|
To Compare The Efficacy Of Muscle Energy Technique Versus Static Stretching With Conventional Physiotherapy Protocol In Young Adults With Mechanical Neck Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aanchal Pancholi |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology,RIICO Institutional area, sitapura, tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9352928493 |
| Fax |
|
| Email |
aanchal1976@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Room No 14, Physiotherapy OPD, Basement,Mahatma Gandhi Hospital, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area,Sitapura tonk road Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology Jaipur |
| Address |
Room No 14, Physiotherapy OPD, Basement,Mahatma Gandhi Hospital, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area,Sitapura tonk road Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area,Sitapura tonk road Jaipur, Rajasthan, India, 302022 |
|
|
Primary Sponsor
|
| Name |
Aanchal Pancholi |
| Address |
16, Pancholi house, Pratap Nagar 2, Gali no 8, Barkat Nagar, Tonk Phatak Jaipur, Rajasthan, India,302015 |
| 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 Saleem Akhtar Naqvi |
Mahatma Gandhi Hospital, Jaipur |
Room No 14, Physiotherapy OPD, Basement,Mahatma Gandhi Hospital, Jaipur
Jaipur
RAJASTHAN |
9680154007
physio.sallu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
– Static stretching with Conventional Therapy |
Static stretching will be given for 6 session total (3 session per week).
Static Stretching for 3-5 repetitions for 20-30 sec hold.
Conventional therapy protocol on daily basis for 2 weeks with application of 15-20 min hot
pack to neck region along with postural advice |
| Intervention |
Muscle energy technique (MET) with Conventional Therapy |
Muscle energy technique will be given for total 6 sessions (3 session per week) for upper
trapezius and levator scapulae muscles.
Muscle energy technique for 3-5 repetitions |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with 4-12 weeks with mechanical neck pain
2. VAS score more than 4 and less than 7
3. Subjects with tightness and weakness of upper trapezius and levator scapulae muscle |
|
| ExclusionCriteria |
| Details |
1.Subjects with less than 4 weeks and more than 12 weeks
2.signs of serious pathology (e.g., malignancy, inflammatory disorder, infection)
3.neck pain with radiation into arms or upper extremity
4.history of cervical spine surgery in previous 12 months
5.history of trauma or fractures in cervical spine
6.Cervicogenic headache
7. Whisplash associated disorders
8. Osteoporosis
9. Any deformity (e.g., Torticollis, Sprengel’s deformity, scoliosis) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Neck Disability Index (NDI)
Goniometry |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Neck Disability Index (NDI)
Goniometry |
1 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Group A – Muscle energy technique (MET) with Conventional Therapy protocol
(strengthening exercises and moist hot pack)
Muscle energy technique will be given for total 6 sessions (3 session per week) for upper
trapezius and levator scapulae muscles.
Muscle energy technique for 3-5 repetitions Group B – Static stretching with Conventional Therapy protocol
(strengthening exercises and hot pack)
Static stretching will be given for 6 session total (3 session per week).
Static Stretching for 3-5 repetitions for 20-30 sec hold.
Conventional therapy protocol on daily basis for 2 weeks with application of 15-20 min hot
pack to neck region along with postural advice.
Treatment would be done under supervision with informed consent. |