| CTRI Number |
CTRI/2025/11/097929 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| 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
|
MENT Physiotherapy protocol to relieve Neck pain and improve Strength and Function |
|
Scientific Title of Study
|
The MENT Protocol: A Multimodal Intervention
Strategy for the Management of Cervical Radiculopathy |
| Trial Acronym |
The MENT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanya Kapoor |
| Designation |
student |
| Affiliation |
AIPT , AIHAS |
| Address |
amity university , noida sector 125 , uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9971172920 |
| Fax |
|
| Email |
Sanyapsk2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandan Kumar |
| Designation |
Professor |
| Affiliation |
AIPT,AIHAS |
| Address |
amity university , noida sector 125 , uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ckumar1@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandan Kumar |
| Designation |
Professor |
| Affiliation |
AIPT,AIHAS |
| Address |
amity university , noida sector 125 , uttar pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ckumar1@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Physiotherapy OPD gate 1 Sector-125, Noida, Uttar Pradesh, 201313, India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy, AIHAS, Amity University |
| Address |
Sector-125, Noida, Uttar Pradesh, 201313, India |
| Type of Sponsor |
Other [Educational University] |
|
|
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 Chandan Kumar |
Physiotherapy OPD |
Gate No 1, Sector-125, Amity University, Noida-201313
Gautam Buddha Nagar
UTTAR PRADESH |
7773923831
ckumar1@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MENT Protocol |
TENS + Hot Pack
Moist heat is applied over the cervical region to relax muscles and improve circulation, followed by transcutaneous electrical nerve stimulation (TENS) using surface electrodes over the affected dermatomes. The technique delivers low-intensity electrical impulses to modulate pain through sensory gating and enhance tissue healing.
CCFT with Pressure Biofeedback (PBU)
The stabilizer pressure biofeedback unit is positioned under the cervical spine while the patient performs gentle head-nodding movements to activate deep neck flexors. The biofeedback device assists in maintaining correct muscle activation and posture control throughout the movement.
Cervical Bracing
The patient performs controlled cervical stabilization in different functional postures such as supine, prone, quadruped, and standing. The chin tuck position is maintained while engaging deep cervical and postural muscles to improve neck stability and alignment.
Neural Mobilization (Median, Radial, and Ulnar Nerves)
Gentle nerve gliding movements are performed in supine position through controlled limb and neck motions specific to each nerve pathway. The mobilization helps restore neural mobility, reduce intraneural tension, and relieve radiating symptoms.
Cervical Isometric Exercises
Manual or elastic resistance is applied in multiple directions (flexion, extension, and lateral movements) while the patient resists without producing actual neck motion. This enhances activation of the cervical stabilizers while maintaining neutral spine posture.
Postural Education and Home Integration
Patients are instructed in ergonomic correction techniques, including maintaining neutral neck posture, adjusting workstation setup, and performing posture-corrective movements like chin tucks and scapular retraction as part of daily activities to prevent symptom recurrence. |
| Comparator Agent |
Standard Exercise protocol |
Heat
Moist hot pack therapy is applied over the cervical and upper shoulder region to relieve muscle spasm, reduce stiffness, and improve tissue extensibility. The gentle warmth promotes relaxation and prepares the cervical musculature for subsequent therapeutic exercises.
Isometric Neck Exercises
The patient performs gentle static contractions of the neck muscles in multiple directions—forward, backward, and sideways—without actual head movement. This technique helps activate and strengthen the cervical stabilizers while maintaining a neutral spine posture.
Cervical Retraction and Scapular Squeezes
The patient is guided to perform chin tuck movements by gently drawing the head backward to align the ears with the shoulders, combined with scapular retraction to squeeze the shoulder blades together. This facilitates postural correction and promotes coordinated cervical-scapular stabilization.
Gentle Range of Motion (ROM)
Active pain-free movements of the neck are performed in all planes—flexion, extension, rotation, and lateral bending—to maintain joint mobility and prevent stiffness. The movements are slow and controlled, avoiding any increase in symptoms
Stretching
Gentle stretching of tight cervical and upper shoulder muscles, such as the upper trapezius, levator scapulae, and sternocleidomastoid, is performed within pain-free limits. The technique aims to restore muscle flexibility and reduce postural tension.
Posture Guidance
Patients receive individualized instruction on maintaining optimal neck and shoulder alignment during sitting, working, and sleeping. Education includes ergonomic advice on workstation setup and activity modification to reduce mechanical strain on the cervical spine.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cervical radiculopathy confirmed by at least two of the following clinical tests
Spurling’s Compression Test
Upper Limb Tension Test
Cervical Distraction Test - Cervical rotation restricted to less than 60 degree toward the symptomatic side
(Optional) Radiological evidence (X-ray or MRI) indicating disc pathology or foraminal narrowing
2.Age range between 25 and 55 years
3.Pain localized to the neck with radiating symptoms to the unilateral upper limb
4. Demonstrated functional limitations such as:
Decreased grip strength
Altered posture
Restricted and painful cervical movement
5.A patient specific functional scale score reflecting mild to moderate functional disability
6. Ability to comprehend and follow instructions, and willingness to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Individuals were excluded if any of them presents
Bilateral upper extremity symptoms
Cervical spine instability
Central cord compression
Spinal tumours or infections
Any history of cervical fractures trauma or surgical intervention
Complaints of dizziness or vertigo
Diagnosed malignancies near the cervical region
Whiplash injuries
2. Severe or progressive neurological deficits such as
Significant motor weakness
Loss of deep tendon reflexes
Bladder or bowel dysfunction
3.Contraindications to TENS therapy, including:
Presence of a cardiac pacemaker or defibrillator
History of epilepsy
Hypersensitivity or skin lesions at electrode site
4.Ongoing participation in any other physiotherapy or interventional rehabilitation program
5.Pregnancy due to precautionary limitations regarding electrical stimulation and neural mobilization techniques
Inability to follow protocol instructions due to language, cognitive, or psychological limitations
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain thershold,
Grip strength
Functional disability |
Baseline & 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grip strength |
Baseline & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
06/12/2025 |
| 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="4"
Days="15" |
|
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
|
|
Brief Summary
|
A common neuromuscular condition called cervical radiculopathy is typified by radiating pain in the arms and neck, frequently accompanied by motor weakness, sensory deficiencies, and functional impairment. Although general exercises and modalities are frequently used in conventional physiotherapy to address symptoms, many patients still suffer from residual disability because of untreated motor control deficits, postural dysfunction, and nerve mechanosensitivity. According to recent research, neurostimulation, motor control training, nerve mobilisation, and ergonomic techniques are all beneficial when used separately to treat cervical radiculopathy. Nevertheless, there is a dearth of strong data examining the combined, protocol-driven effects of these interventions. This research seeks to address that deficiency by presenting and substantiating an innovative, evidence-based, multi-dimensional intervention protocol aimed at critical areas of dysfunction in cardiac rehabilitation patients. Utilising objective outcome measures like the CRIS scale, NPRS, and hand-held dynamometer, this study aims to develop a standardised, quantifiable, and clinically relevant intervention, which may enhance rehabilitation protocols and long-term results for cervical radiculopathy. |