| CTRI Number |
CTRI/2021/11/037982 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of strengthening and stretching and contract relax and antagonist contract for pain, function and movement in patient with mechanical neck pain |
|
Scientific Title of Study
|
COMPARING THE EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE (MET) AND PROPRIORECEPTIVE NEUROMUSCULAR FACILITATION (PNF) EXERCISE ON PAIN, FUNCTION AND MOVEMENT IN PATIENT WITH MECHANICAL NECK PAIN |
| Trial Acronym |
MNP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma kc |
| Designation |
UG student |
| Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
| Address |
Laxmi Memorial College of Physiotherapy, Balmatta, Mangalore, Department of physiotherapy, 1st floor, Aj tower
Balmatta, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7975160273 |
| Fax |
2218969 |
| Email |
susmakc002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
| Address |
Laxmi Memorial College of Physiotherapy, Balmatta, Mangalore, Department of physiotherapy, Aj tower, 1st floor
Balmatta, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9449729147 |
| Fax |
2218969 |
| Email |
priya.sv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
LAXMI MEMORIAL COLLEGE OF PHYSIOTHERAPY |
| Address |
Laxmi Memorial College of Physiotherapy, Balmatta, Mangalore,Department of physiotherapy, Aj tower , 1st floor
Balmatta, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9449729147 |
| Fax |
2218969 |
| Email |
priya.sv1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aj Institute of Medical Science and Research centre |
|
|
Primary Sponsor
|
| Name |
SUSHMA KC |
| Address |
Laxmi Memorial College of Physiotherapy, Balmatta, Mangalore |
| 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 |
| SUSHMA KC |
AJ INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
OPD, Department of physiotherapy, ground floor,Kuntikana, Mangalore
Dakshina Kannada
KARNATAKA |
7975160273
2218969
susmakc002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJ INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle Energy Technique (MET) and Proprioreceptive Neuromuscular Facilitation (PNF) |
MET is stretching of tightened muscles and strengthening the weakend one and PNF is neuromuscular technique which includes contract relax and antagonist contract given for mechanical neck pain. Both the treatment will be given for duration of 4 weeks |
| Intervention |
Muscle Energy Technique (MET) and Proprioreceptive Neuromuscular Facilitation (PNF) |
MET is stretching of tightened muscles and strengthening the weakend one and PNF is neuromuscular technique which includes contract relax and antagonist contract given for mechanical neck pain. This treatment will be given for the duration of four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
college going students
Neck pain of minimum duration of 1 week
Both males and females
Tightness of upper trapezius, levator scapulae, scalene muscle on painful side
|
|
| ExclusionCriteria |
| Details |
Inflammatory conditions
Malignant and neurological conditions
Metabolic disease neck pain radiating into arms and upper extremity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Universal Goniometer for movement, Visual Analogue Scale(VAS) for pain and Neck Disability Scale (NDI) for function |
Will be assessed at baseline and after 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometer for neck movement, VAS for pain and NDI for neck functions |
4 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
20/11/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
None
|