| CTRI Number |
CTRI/2025/08/093892 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Auricular Vagus Nerve Stimulation and Manual Therapy to Reduce Pain and Improve Function in People with Neck Pain |
|
Scientific Title of Study
|
Cranio-Cervicomyofascial Release and Auricular Vagus Nerve Stimulation for Pain, Autonomic Modulation, and Function in Mechanical Neck Pain: A Randomized Controlled Trial |
| Trial Acronym |
NECK-RESET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Block 4. room no 105.
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Block 4. room no 105.
Kapurthala
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab, Block-4, room no 105, Lovely Professional University
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab, Block-4, room no 105, Lovely Professional University
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
rameshpatra2208@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Block-4, Lovely Professional University |
| Type of Sponsor |
Research institution |
|
|
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 Ramesh Chandra Patra |
Uni Hospital, Lovely Professional University Faculty of Applied Medical Sciences |
Lovely Professional University, Jalandhar-Delhi, G.T. Road, Block 3.
Kapurthala
PUNJAB |
09653174563
rameshpatra2208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Osteopathic Cranio-Cervicomyofascial Release (CCMR) |
Suboccipital release (bilateral), Cranial fascial release vault hold, frontalandtemporal decompression, sphenobasilar balance indirect technique 1–2 cycles each. Cervical myofascial release – anterior,posterior,lateral cervical fascia . i |
| Comparator Agent |
Traditional Physiotherapy |
Pot pack, Ultrasound therapy and exercise |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Mechanical neck pain with or without referred shoulder/upper-back pain more than 2 weeks, NPRS more than 3/10.
2. NDI more than 10/50.
3. Patient Able to attend 2 sessions per week for 4 weeks and follow home program.
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria were: radicular cervical syndrome; any kind of fracture or postoperative condition of the cervical spine; any utilization of medical intervention, physiotherapy intervention since past 4 weeks; history of whiplash injury; cervical radiculopathy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index (NDI, 0–50) |
4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain intensity: 11-point NPRS (current/avg last week).
2. Pain sensitivity: Pressure Pain Thresholds (PPT, kg/cm²) at: suboccipitals, upper trapezius, C5 paraspinals (bilateral); 3 trials/site.
3. Cervical ROM: flexion/extension, rotation, lateral flexion via inclinometer or CROM.
4. Posture: Craniovertebral angle (digital photogrammetry).
5. Autonomic modulation: HRV (5-min seated, ECG or validated HR monitor): time-domain RMSSD, freq-domain HF power (0.15–0.4 Hz), LF/HF.
6. Psychosocial: Pain Catastrophizing Scale (PCS), Tampa Kinesiophobia (TSK-11).
7. Sleep/Quality of life: PSQI, EQ-5D-5L.
8. Global Perceived Effect (GPE); Patient-Specific Functional Scale (PSFS).
9. Analgesic use (diary) and adverse events.
|
4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="0"
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
|
|
Brief Summary
|
Neck discomfort is a problem that can affect any of the tissues surrounding the neck and is caused by a variety of ailments or diseases. Objectives The aim of the study was to Evaluate whether Osteopathic Cranio-Cervicomyofascial Release (CCMR) combined with transcutaneous auricular vagus nerve stimulation (taVNS) improves disability at 4 weeks versus controls
|