| CTRI Number |
CTRI/2025/07/090807 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Improving Neck Posture and Reducing Pain Using Muscle Feedback Training |
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Scientific Title of Study
|
Effect of Electromyography Biofeedback Training to Deep Neck Flexor in Mechanical Neck Pain Patients with Forward Head Posture
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rabia Aziz |
| Designation |
Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room number 522, Department of Physiotherapy, School of Nursing Sciences and Allied Health, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
9213136786 |
| Fax |
|
| Email |
rabiaaziz_sch@jamiahamdard.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Irshad Ahmad |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Research Lab, Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana
Faridabad HARYANA 121004 India |
| Phone |
8178071369 |
| Fax |
|
| Email |
kkut84440@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Irshad Ahmad |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Research Lab, Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana
Faridabad HARYANA 121004 India |
| Phone |
8178071369 |
| Fax |
|
| Email |
kkut84440@gmail.com |
|
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Source of Monetary or Material Support
|
| Research Laboratory, Department of Physiotehrapy, facult of Allied Hea;th Sciences, Manav Rachna International Institute of Research and Studies, sector-43, Delhi Surajkund Road, Faridabad, Haryana, 121004 |
|
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Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies, sector 43, Delhi Surajkund Road, Faridabad, Haryana, 121004 |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
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|
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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 Irshad Ahmad |
Manav Rachna International Institute of Research and Studies |
Research Laboratory, Department of Physiotherapy,Faculty of Allied Health Sciences, Manav Rachna International Institute of Research and StudiesSector-43, Faridabad, Delhi Surajkund road, Haryana 121004 Faridabad HARYANA |
8178071369
kkut84440@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna International Institute of Research and Studies Ethical Committee |
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: Z682||Body mass index (BMI) 20-29, adult, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional DCF Training Without Biofeedback |
Exercise Type: Deep cervical flexor training using chin tuck maneuver
Position: Same as experimental group (sitting upright without back support)
Instructions:
Participants are instructed to perform chin tuck exercises with verbal cues only.
No feedback device is provided; focus is on patient effort and therapist guidance.
Monitoring:
Verbal and tactile cues are used by the therapist to correct technique.
No EMG electrodes or visual/auditory feedback is used.
Repetitions: 10 repetitions per session
Hold Time: 15 seconds per repetition
Rest Between Reps: 10 seconds
Frequency: 1 session per day for 14 consecutive days
Supervision: Exercises performed under therapist supervision to ensure consistency and avoid compensatory movements. |
| Intervention |
EMG Biofeedback-Assisted DCF Training |
Exercise Type: Deep cervical flexor training via chin tuck maneuver
Position: Sitting upright on a stool with back unsupported, feet flat on floor
Instructions:
The participant is instructed to gently draw the chin inward (like making a double chin) without cervical flexion or shoulder movement.
Emphasis is placed on isolating deep neck flexor activation without activating the sternocleidomastoid or superficial muscles.
EMG Biofeedback Setup:
Device: Portable EMG biofeedback unit with visual display and auditory signal
Electrode Placement:
Longus colli: Over anterior neck, medial to sternocleidomastoid
Upper trapezius: Over midpoint between acromion and C7 (for monitoring compensatory overuse)
The screen provides real-time graphical feedback showing DCF activity and alerts when upper trapezius activity increases.
Repetitions: 10 repetitions per session
Hold Time: 15 seconds per repetition
Rest Between Reps: 10 seconds
Frequency: 1 session per day for 14 consecutive days
Supervision: Exercises were performed under therapist supervision during sessions to ensure proper electrode placement and technique adherence. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
aged 20 to 50 years with mechanical neck pain and CVA more than 50 degrees were recruited |
|
| ExclusionCriteria |
| Details |
Psychiatric disorder, Metabolic disorder, Hormonal disorder |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| CVA (using digital photography and goniometry), VAS for pain, NDI for functional disability, and cervical active range of motion (AROM) |
Baseline, after 2 weeks, After 4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life (SF-12) |
At baseline, after week 2, after week 4 |
|
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Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
30/07/2025 |
| 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) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kkut84440@gmail.com].
- For how long will this data be available start date provided 12-12-2025 and end date provided 12-01-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Effect of Electromyography Biofeedback Training to Deep Neck Flexor in Mechanical Neck Pain Patients with Forward Head Posture – A Prospective Interventional Study
Background & Rationale: Mechanical neck pain and forward head posture (FHP) are increasingly common among individuals with sedentary lifestyles, especially those engaged in prolonged screen-based activities. FHP alters cervical spine mechanics, weakens deep cervical flexors (DCF), and leads to muscle imbalances and chronic pain. While chin tuck exercises are standard in rehabilitation, many patients struggle with proprioceptive awareness, limiting the effectiveness of conventional training. Electromyography (EMG) biofeedback offers real-time visual and auditory cues to enhance muscle activation and motor control, potentially improving postural correction and reducing symptoms.
Objective: To assess the clinical efficacy of EMG biofeedback-assisted Deep Cervical Flexors (DCF) training versus conventional Deep Cervical Flexion exercises in individuals with mechanical neck pain and FHP.
Methodology: Patients aged 20–50 years with diagnosed mechanical neck pain and CVA <50° will be recruited and randomly allocated to either an EMG biofeedback group or a control group. Both groups will perform identical DCF exercises daily for four weeks. Outcome measures will include Craniovertebral Angle (CVA), Visual Analog Scale (VAS) for pain, Neck Disability Index (NDI), and cervical Active Range of Motion (AROM), assessed pre and post-intervention.
Clinical Significance: This study aims to generate evidence for the integration of EMG biofeedback into routine physiotherapy practice. If proven effective, it can offer a low-risk, accessible, and efficient intervention to improve posture, alleviate pain, and restore function in patients with cervical dysfunctions, particularly FHP. Findings from this study may inform future guidelines on cervical rehabilitation protocols.
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