| CTRI Number |
CTRI/2024/10/075822 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| 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
|
postural corrective exercise program with therapeutic ultrasound vs isometric cervical exercises and intermittent cervical traction in forward head posture |
|
Scientific Title of Study
|
Efficacy of postural corrective exercise program with therapeutic ultrasound vs isometric cervical exercises and intermittent cervical traction on pain and function in forward head posture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nuresan Naznin |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of medical sciences and technology |
| 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 |
8058186616 |
| Fax |
|
| Email |
nuresan1989@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Goswami |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of medical sciences and technology |
| Address |
Orthopaedic Physiotherapy Lab,
Mahatma Gandhi Physiotherapy college ,Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, Sitapura ,Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8058186616 |
| Fax |
|
| Email |
drmeghamunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Goswami |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of medical sciences and technology |
| Address |
Orthopaedic Physiotherapy Lab,
Mahatma Gandhi Physiotherapy college ,Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, Sitapura ,Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8058186616 |
| Fax |
|
| Email |
drmeghamunshi@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 |
Nuresan Naznin |
| Address |
34/A, Baburukhalifa Lane ,PO Berhampore, Berhampore(wb),Murshidabad, West Bengal , 742101 |
| 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 Megha Goswami |
Mahatma Gandhi Hospital,Jaipur |
Room no 14
Physiotherapy OPD
Basement
Jaipur
RAJASTHAN |
8058186616
drmeghamunshi@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: R293||Abnormal posture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intermittent Cervical Traction followed by Isometric Cervical Exercises |
1.Isometric Cervical Exercise,Hold for 10 seconds. Relax. Repeat 5 times.Do the exercise on the 4 side of head,Repeat 5 times for 4 weeks.
2.Cervical Traction parameters, 15â° of cervical flexion,60sec hold time and 20sec relaxation,total time of treatment 15 min. |
| Intervention |
Ultrasound Therapy followed by Postural Corrective Exercises Programme |
1.A.Strengthening Cervical Flexors(Chin Tuck),hold it for 6 seconds and relax, then repeat 10 times for 4 weeks.
B.Strengthening of Shoulder Retractor hold for 6 seconds and then relax repeat 10 times for 4 weeks.
C. Stretching of pectoral,(with theraband)hold the position for 15-30 sec,repeat 3 times for 4 weeks.
D.Stretching of Sternocleidomastoid,Hold for 30 seconds then relax and repeat 3 times, repeat for the opposite side for 4 weeks
2.Ultrasound therapy parameter 1 MHz pulsed ultrasound with 1.0 watts/cm2 intensity was given on the suboccipital region for 4 minutes
duration for 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Neck pain within the last 3 month
2.Patients with rounded shoulder
3.Patients with Craniovertebral Angle less than 49 degree
4.Pain intensity equal to or greater than 2 points in the numerical pain rating scale (NPRS)
5.Cervical radiculopathy
6.Patients willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Anxious about being restrained or claustrophobic
2.History of spine surgery
3.Pregnancy
4.Osteoporosis
5.History of fracture in neck or shoulder region
6.Patient with cervical rib , disc pathology
7.Any neurological or vascular diseases
8.Patient unwilling to participate
|
|
|
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 |
1.Functional disability scale by NDI( neck disability index)
2.Pain scale by NPRS(Numeric Pain Rating Scale)
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional disability scale by NDI( neck disability index)
2.Pain scale by NPRS(Numeric Pain Rating Scale)
|
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| 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:This group of subject will receive ultrasound therapy followed by Postural
Corrective exercises programme.
Ultrasound therapy
parameter 1 MHz pulsed ultrasound with 1.0 watts/cm2 intensity was given on the
sub-occipital region for 4 minutes
duration.
Postural Corrective Exercises: Postural corrective exercises consist 2 strengthening and 2 stretching
exercises
|
Exercises
|
Description
|
|
Strengthening Cervical Flexors(Chin Tuck)
|
The participant is asked to chin tuck in the supine position with the
head in contact with the floor, keep the head straight and hold it for 6
seconds and relax, then repeat the exercise. This exercise improves the
function of deep flexor muscles of the upper cervical region.
|
|
Strengthening of Shoulder Retractor
|
This exercise is done in the standing position by using a thera-band
pulling the shoulders back. The participant is instructed to retract and
pinch scapula together without elevation or extension in the shoulders and
hold this position for 6 seconds and then relax.
|
|
Exercises
|
Description
|
|
Stretching of pectoral
|
Asked the subject to stand and hold a theraband behind their back and
gently pull their shoulder into extension they will feel a stretch in the
chest. hold the position for 15-30 sec. repeat 3 times
|
|
Stretching of Sternocleidomastoid
|
The subject is in sitting and asked to place left arm behind the body
and depress the shoulder, tuck chin and slowly draw her right ear to the
right shoulder, also is asked to rotate her neck upward toward the ceiling a
slight stretch will be felt on the left side. Hold this position for 30
seconds then relax and repeat it for the opposite side.
|
Group B: This group of subject
will receive Intermittent Cervical Traction followed by Isometric Cervical
Exercises Traction parameters: patient
supine, 15â° of cervical flexion, traction force 10% of weight of body of the
patient, with a 60s hold time and 20s relaxation, and the relaxation force of
50% of the pull force for a total time of treatment 15 min. The
10% weight administered was the minimum weight; this was increased gradually
according to the tolerance of each patient to the extent to which there was a
desired pull at the cervical region.
Isometric
Cervical Exercise:
|
Exercises
|
Description
|
|
Neck
Isometric strengthening
|
The
exercise is done in a sitting position, shoulders and head will be relax
using a chair with arms. Therapist Press their palm against subjects forehead
and ask to Resist with his/her neck muscles. Hold for 10 seconds. Relax. Repeat
5 times. Do the exercise on the 4 side
of head. Repeat 5 times.
|
|