| CTRI Number |
CTRI/2024/11/076846 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Combination Of Two Different Physiotherapy Techniques In University Students With Forward Head Posture |
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Scientific Title of Study
|
A Combined Approach Of Deep Cervical Flexor Training And Post Isometric Relaxation Technique On Physiotherapeutic Outcomes In University Students With Forward Head Posture: A Randomised Controlled Trial |
| 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 Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No- 104, 1st Floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India
South DELHI 110025 India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No- 104, 1st floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India
South DELHI 110025 India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Ms Tasmia Siddiqui |
| Designation |
Post Graduate Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No- 207, 1st Floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India
South DELHI 110025 India |
| Phone |
9958324512 |
| Fax |
|
| Email |
tsiddiqui6217@gmail.com |
|
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Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Nagar, Okhla, South Delhi-110025, India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences,Jamia nagar, New Delhi-110025 |
| Type of Sponsor |
Other [University funded by centeral goverment ] |
|
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Details of Secondary Sponsor
|
|
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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 |
| Dr Saurabh Sharma |
Room no. 201, Human performance lab, Centre for Physiotherapy and Rehabilitation Sciences |
Room no-104 ,Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana md Ali Jauhar Marg, New Delhi-110025 South DELHI |
9899214134
ssharma@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA |
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: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Static stretching exercises for upper trapezius and sternocleidomastoid muscle, 3 days per week for 4 weeks in addition to strengthening exercise of deep cervical flexors and scapular retractor muscles 3 sets of 12 repetitions with 6 seconds hold, total duration of each session will be 15 minutes. |
| Intervention |
Deep cervical flexor training |
Deep cervical flexor training will be given using pressure biofeedback which will be placed over the suboccipital part and the patient is asked to do light nodding which will be started at 20 mmHg and 2mmHg pressure will be increased at every stage until 30mmHg pressure is reached. A total of 3 sets will be performed; one set will consist of repeating the motion 10 times for 10 seconds. The break time will be 5 seconds per movement for 4 weeks, 3 days a week, total duration of single session will be 15 minutes. In total 12 sessions will be given. Additionally 15 min hot pack will be given before the intervention. |
| Intervention |
Post isometric relaxation technique |
post isometric relaxation technique for 4 weeks, 3days/week, total duration for a single session will be 15 minutes. In total 12 sessions will be given. The treatment will be directed towards relaxation for upper trapezius, Sternocleidomastoid muscle, and pectoralis minor muscle for 3 repetitions. Additionally a 15 min hot pack will be given before the intervention. |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
subjects with CVA between 45-50 degrees
NDI value between 5- 24 (mild to moderate disability scores on NDI)
NPRS value between 3 -7
Both males and female between 19 to 28 years of age |
|
| ExclusionCriteria |
| Details |
Patients with cervical spine and spinal deformities, congenital upper extremities
disorders.
No history of neck and shoulder surgery within the past three months
History of surgical or neurologic disorders. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
craniovertebral angle
muscle activation
posture analysis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disability
Pain
Range of Motion |
4 weeks |
|
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
24/11/2024 |
| 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
|
Introduction: Forward head posture (FHP) is characterized by excessive anterior positioning of the head about a vertical reference line, increased lower cervical spine lordosis (head forward, middle cervical spine extended, lower cervical spine flexed), rounded shoulders, and thoracic kyphosis. This can occur while sitting or standing. (Franke et al., 2015; Frey, G. 2011) .In a study conducted by Kim et al on the correlation between the degree of the FHP according to the craniovertebral angle (CVA) and the neck disability indices, it was found that the degree of the Forward Head Posture according to the CVA can be used as an important index in determining the resulting functional disability of the neck.(Nemmers et al., 2009). Post-isometric relaxation is a muscle energy technique (MET) that involves moving the patient’s muscles in a certain direction against the therapist’s counterforce. This is accomplished by the Golgi tendon organ (GTO) when the muscle contracts isometrically. The Golgi Tendon Organ activates and responds by inhibiting reflexes and contracting antagonist muscles through submaximal contractions and stretching. It manages musculoskeletal disorders by restoring biomechanics, eliminating mobility restrictions, and relieving discomfort. (Scoppa, F. 2012)
Objective: To investigate the effect of deep cervical flexor training (DCFT) and post- isometric relaxation technique (PIR) on CVA in university students with forward head posture. Significance of the study: The present study will elucidate the combined effect of post-isometric relaxation (PIR) technique and deep cervical flexor training on forward head posture. It will add information to the existing gap in knowledge by unraveling the combined effects of PIRT and DCFT on any alteration in the activation pattern of these muscles in university students with forward head posture and to incorporate in the rehabilitation of forward head posture patients.
Moreover, other studies have used photographic methods to analyze posture. Our study will use more reliable and valid software for posture analysis.
By comprehensively assessing multiple outcome measures, including Craniovertebral angle, posture, disability, pain intensity, Range of motion, and muscle activity, this study aims to provide a holistic understanding of the therapeutic potential of Deep Flexor Cervical Training and Post Isometric Relaxation Technique in managing Forward Head Posture. The result of the study can be directly used by clinicians to achieve improvements in patients with FHP.
NULL HYPOTHESIS: • There will be no significant effect of deep cervical flexor training and post-isometric relaxation technique on a craniovertebral angle, EMG, posture, pain, disability, and ROM in university students with forward head posture EXPERIMENTAL HYPOTHESIS: There will be a significant effect of deep cervical flexor training and post-isometric relaxation technique on a craniovertebral angle, EMG, posture, pain, disability, and ROM in university students with forward head posture.
Methods: Before initiating the study, subjects will be asked to fill NDI questionnaire as well as NPRS, following which their CVA, posture, range of motion, and muscle activation will be assessed. The pre-intervention evaluation will involve assessing the EMG % MVIC of specific muscles including the serratus anterior, sternocleidomastoid, and upper trapezius. After the initial assessment, the participating athletes will be randomly divided into Two groups. Group 1 will receive Post isometric relaxation technique along with DCFT, while Group 2 will receive a conventional physiotherapy treatment. Both groups will receive a hot pack for 15 min before exercise. Patients will be asked to perform the exercises 3 times a week for 4 weeks. Outcome measures will be assessed at baseline after 4 weeks of training and after 6 weeks of follow-up. DCFT will be done using pressure biofeedback which will be placed over the suboccipital part and the patient is asked to do light nodding which will be started at 20 mmHg and 2mmHg pressure will be increased at every stage until 30mmHg pressure is reached A total= of 3 sets will be performed; one set will consist of repeating the motion 10 times for 10 seconds. The break time will be 5 seconds per movement for 4 weeks. (Juchul et al., 2018). When the performance was correctly conducted in each stage without reward mobility, the pressure was increased in the next stage. (Fernandez et al., 2007) PIRT for Upper trapezius, Sternocleidomastoid muscle, and pectoralis minor muscle, each muscle received 3 repetitions, 3 sessions per week over 4 weeks. (Haytham et al., 2023). For pectoralis minor: the patient is asked to apply approximately 20% of his strength to protract the shoulder girdle in the supine position or asked to match the therapist’s strength. The isometric contraction will be maintained for 7 seconds while holding the breath and then the patient was asked to relax and exhale. During the period of relaxation, the therapist will stretch the pectoralis minor muscle to its new length and the stretch force will be maintained for 10 seconds (Prerana & Amarnatha, 2019). For upper trapezius and sternocleidomastoid muscles are stretched by the therapist moving the subject’s head into the appropriate position. Once resistance or a barrier is felt, the position is maintained, and the subjects will be instructed to isometrically contract the target muscle for 5 seconds at 20% of their maximum contraction against light resistance from the therapist. Then, the subjects are instructed to relax for 5 seconds before passively stretching for 30 seconds until reaching a new barrier. (Haytham et al., 2023) After every 10 sessions, examine the CVA, if there is an increase of 1 degree then progress to the next stage otherwise the patient will remain in the same stage. Control group: will receive conventional treatment as, static stretching exercise for upper trapezius and sternocleidomastoid. 3 days/week throughout 4 weeks, in addition to strengthening exercises of deep cervical flexors and scapular retractor muscles, 3 sets of 12 repetitions with 6-sec hold in addition to postural advice. ( Haytham et al., 2023)
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