| CTRI Number |
CTRI/2015/02/005572 [Registered on: 24/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
23/02/2015 |
| 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
|
A comparative study to find out the effects of muscle energy technique and passive stretching in subjects with mechanical neck pain. |
|
Scientific Title of Study
|
Effects of muscle energy technique and passive stretching on pain and functional status in subjects with mechanical neck pain: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 |
APOORVA PHADKE |
| Designation |
PG STUDENT |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY
THUBE PARK,SHIVAJI NAGAR
Pune
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
apoorva.phadke07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima Bedekar |
| Designation |
Professor and Principal |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY
THUBE PARK, SHIVAJI NAGAR
Pune
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
APOORVA PHADKE |
| Designation |
PG STUDENT |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY
THUBE PARK, SHIVAJI NAGAR
Pune
MAHARASHTRA
411005
India |
| Phone |
|
| Fax |
|
| Email |
apoorva.phadke07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
SANCHETI INSTITUTE OF ORTHOPEDIC AND REHABILITATION |
| Address |
SANCHETI HOSPITAL
SHIVAJINAGAR, PUNE-411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nilima Bedekar |
SANCHETI INSTITUTE COLLEGE OF PHYSIOTHERAPY |
SANCHETI HEALTHCARE ACADEMY
THUBE PARK
SHIVAJI NAGAR
Pune
MAHARASHTRA |
02025539393
nilimabedekar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti institute for orthopedics and rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mechanical neck pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle energy technique |
Post isometric relaxation technique to upper trapezius and levator scapulae with7 sec hold for 5 repetitions, once in a day for 7 days |
| Intervention |
Passive stretching |
Passive stretching to upper trapezius and levator scapulae with 20 sec hold for 5 repetitions,once in a day for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
• Age 18-52 years
• Both males and females
• Neck pain on VAS 4-8 [moderate cases].
• Sub-acute or chronic cases [4-12 weeks}.
|
|
| ExclusionCriteria |
| Details |
•Signs of serious pathology (e.g. malignancy, inflammatory disorder, infection)
•History of cervical spine surgery in previous 12 months
•History of trauma or fractures in cervical spine
•Signs of Cervical radiculopathy or myelopathy
•Vascular syndromes such as basilar insufficiency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PAIN ON VISUAL ANALOGUE SCALE(VAS)
|
o no pain
10 maximum pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disabiliy index (NDI) |
o no disability
5 maximum disability |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2013 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of this study was to find out the effectiveness of Muscle energy technique when compared with passive stretching(static) on pain and functional status in subjects with mechanical neck pain. It concluded that the MET is better than stretching.
|