| CTRI Number |
CTRI/2018/01/011073 [Registered on: 01/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2018 |
| 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
|
A clinical trial to compare the effects of two treatments, McKenzie approach and neck exercises on Forward Head Posture in adults of age 18-35. |
|
Scientific Title of Study
|
Effect of McKenzie approach and Neck exercises on Forward Head Posture in young adults. |
| Trial Acronym |
FHP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnupriya Deshpande |
| Designation |
Intern |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Physiotherapy OPD,
Krishna Hopsital,
Krishna Institute of Medical Sciences,
Malkapur,
Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9145332290 |
| Fax |
|
| Email |
vish.d@live.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishnupriya Deshpande |
| Designation |
Intern |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Physiotherapy OPD,
Krishna Hopsital,
Krishna Institute of Medical Sciences,
Malkapur,
Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9145332290 |
| Fax |
|
| Email |
vish.d@live.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishnupriya Deshpande |
| Designation |
Intern |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Physiotherapy OPD,
Krishna Hopsital,
Krishna Institute of Medical Sciences,
Malkapur,
Karad
Satara
MAHARASHTRA
415110
India |
| Phone |
9145332290 |
| Fax |
|
| Email |
vish.d@live.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of Medical Sciences Karad |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of Medical Sciences Karad |
| Address |
Krishna Institute of Medical Sciences,
Malkapur,
Karad- 415 110 |
| 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 |
| Vishnupriya Deshpande |
Krishna Hospital |
Krishna Physiotherapy OPD, Krishna Hospital,
Malkapur,
Karad- 415 110
Satara
MAHARASHTRA |
99145332290
vish.d@live.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Krishna Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Forward Head Posture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of McKenzie approach and neck exercises |
Retraction, retraction with extension, retraction with flexion, retraction with rotation, postural correction for 15 minutes,
Deep cervical flexors strengthening of 20 second hold, 10 times each, suboccipitals stretching of 30 second hold, 4 times each, 3 times a week for 4 weeks |
| Intervention |
McKenzie approach |
Retraction, retraction with extension, retraction with flexion, retraction with rotation, postural correction for 15 minutes, 3 times a week for 4 weeks |
| Comparator Agent |
Neck exercises |
Deep cervical flexors strengthening of 20 second hold, 10 times each.
Suboccipitals stretching of 30 second hold, 4 times each, 3 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Anterior weight bearing of 15mm or more in lateral view of Plain Radiography
Pectoralis Minor length test measurement of 2cm or less |
|
| ExclusionCriteria |
| Details |
History of Cervical spine surgery
Cervical spine fractures
Rheumatoid Arthritis
Cervical disc herniation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cranial Vertical Angle
Cranial Rotation Angle |
0, 2, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical Range of Motion
Craniocervical Flexion Test
Neck Disability Index |
0, 2, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2017 |
| Date of Study Completion (India) |
05/02/2018 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomized, parallel group, single blinded study comparing the effect of McKenzie approach and neck exercises on Forward Head Posture. The first group will receive McKenzie exercises 3 days per week for 4 weeks. The second group will receive deep cervical flexors strengthening and Suboccipitals stretching 3 days per week for 4 weeks. The third group will receive a combination of both the treatments. The outcome measurements are Cranial Vertical Angle, Cranial Rotation Angle, Neck Disability Index, Craniocervical flexion test and Cervical range of motion. These outcome measures will be taken at 0 weeks, 2 weeks and after 4 weeks of treatment. |