| CTRI Number |
CTRI/2025/03/082047 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
comparing effect of mckenzie exercise and traditional therapy on pain, neck disability and forward neck posture among school students with upper cross syndrome |
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Scientific Title of Study
|
comparative effectiveness of mckenzie exercises and conventional therapy on pain, disability and craniovertebral angle among school students with upper cross syndrome”
|
| Trial Acronym |
nil
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Nandi Abirami |
| Designation |
PG student |
| Affiliation |
RV college of physiotherapy |
| Address |
RV College of Physiotherapy
Department of Musculoskeletal Sciences
Room number 08
No.CA 2 83 9th main 4th block jayanagar bengaluru karnataka 560011
Bangalore
KARNATAKA
560076
India |
| Phone |
7013412910 |
| Fax |
|
| Email |
abiraminandyalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paul Daniel Vk |
| Designation |
Professor |
| Affiliation |
RV college of physiotherapy |
| Address |
RV College of Physiotherapy
Department of Musculoskeletal Sciences
Room number 08
Bangalore
KARNATAKA
560011
India |
| Phone |
9008173167 |
| Fax |
|
| Email |
pauldanielvk.rvcp@rvei.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paul Daniel Vk |
| Designation |
Professor |
| Affiliation |
RV college of physiotherapy |
| Address |
RV College of Physiotherapy
Department of Musculoskeletal Sciences
Room number 08
No.CA 2 83 9th main 4th block jayanagar bengaluru karnataka 560011
KARNATAKA
560011
India |
| Phone |
9008173167 |
| Fax |
|
| Email |
pauldanielvk.rvcp@rvei.edu.in |
|
|
Source of Monetary or Material Support
|
| RV College of Physiotherapy No.CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar India Bengaluru Karnataka 560011 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nandi Abirami |
RV public school |
Rashtriya Vidyalaya Rd, Upparahalli, Mavalli, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA |
7013412910
abiraminandyalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| RV institution ethical commitie |
Approved |
| RV institution ethical commitie |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (3) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
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|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional therapy |
The 8-week therapy program is designed to progressively address muscle imbalances and improve mobility, flexibility, and strength, focusing on the cervical and upper back regions. During weeks 1-2, the program starts with myofascial release targeting the upper trapezius, sternocleidomastoid, and levator scapulae. The pressure is applied to tender areas and held for 30 seconds, with 1-3 sets based on individual tolerance. In weeks 3-4, stretching exercises are introduced, including the sternocleidomastoid, levator scapulae, upper trapezius, and standing pectoral stretches. These stretches are performed for 1-3 sets, with 10 to 15 repetitions per stretch. In weeks 4-6, strengthening exercises are added to the routine, including chin tucks, resisted cervical posterior translation, floor prone scaption, and quadruped ball chin tucks, with 1-2 sets of 10 to 15 repetitions. The intensity increases in weeks 7-8, with the same exercises performed for 3-4 sets of 10 to 15 repetitions, focusing on building strength and stability. This gradual progression helps improve posture, reduce muscle tension, and strengthen the cervical and upper back muscles |
| Intervention |
McKenzie exercises |
The McKenzie Method exercise program, designed for three sessions per week over 8 weeks, aims to improve cervical spine mobility, neck strength, and shoulder stabilization. It includes cervical protrusion and cervical retraction, where repeated movements centralize symptoms by focusing on retraction and extension at the end range. Prone scapular stabilization is an isometric exercise where the patient lies face down, tucks the chin, rolls the shoulders back, and squeezes the shoulder blades together, holding for 15-30 seconds, repeated 8-15 times. Deep neck flexor (chin tucks) involves standing with the back against the wall, activating the front neck muscles and holding the position for 5 seconds, repeated 10 times. Shoulder shrug McKenzie exercises involve a chin tuck while elevating the shoulders, holding briefly before returning to normal, with 10 repetitions done three times a day. Repeated shoulder flexion includes flexing the shoulder and holding the position for 15-30 seconds, repeating 2-4 times daily. Neck flexion McKenzie exercises involve dropping the head toward the chest, interlocking the fingers behind the head, and pointing the elbows downward, to stretch and strengthen the neck. These exercises target pain reduction, improved posture, and strengthening of the neck and shoulder muscles. |
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Parents /legal guardians of the students voluntarily willing their ward to be the part of the study and have signed consent form and parents assent form
Subjects with craniovertebtal angle less than 48
Neck disability index at least score of 10 (mild to moderate)
Tightness test for pectoralis major and minor muscle and upper trapezius
Subjects of age group 10 to 16 years |
|
| ExclusionCriteria |
| Details |
Subjects with recent fractures in cervical or vertebra and shoulder
Subjects with congenital shoulder deformities
Subjects with malignancy condition
Subjects with spinal cord deformities |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale
Neck disability index
Craniovertebtal angle
|
baseline
8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
18/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Upper cross syndrome is characterized by tightness of the upper trapezius and levator scapulae on the dorsal side , weakening of the deep cervical flexors centrally, and weakness of the middle and lower trapezius Upper cross syndrome presents with forward neck posture , thoracic spine hunching , elevated and protected shoulder Upper cross syndrome effects around 24% of school aged students, resulting in postural problems , muscle weakness and stiffness. Children often develop postural anomalies due to poor posture caused by modern life style habits .The problem of extended for roughly 5 to 10 hour’s, classroom furniture can cause rounded upper back, and tension from carrying a backpack can lead to forward neck posture and trunk position Upper cross syndrome is assessed by specific test which involves to evaluate the muscle tightness and weakness of the muscles and check for craniovertebtal angle for forward neck posture Studies have been proving the effectiveness of McKenzie exercise and conventional therapy on upper cross syndrome, improving neck disability, forward neck posture , and pain in adults population but there is no study to compare the effect of McKenzie exercise and conventional therapy on pain , neck disability and craniovertebtal angle among school students with upper cross syndrome The outcome measures will be using , neck disability index, visual analogue scale, tightness and weakness muscle test and measure craniovertebtal angle. The time period is 8 Week’s of protocol
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