| CTRI Number |
CTRI/2025/09/095001 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| 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
|
Effect of Ear Electrical Dry Needling and Face/Neck Manual Therapy on Headache and Jaw Pain in Adults |
|
Scientific Title of Study
|
Investigating the Efficacy of Electrical Dry Needling for Auricular Vagus Nerve Stimulation Combined with Craniofacial Manual Therapy in the Management of Cervicogenic Headache and Temporomandibular Disorders: A Randomized Controlled Trial |
| Trial Acronym |
NILL |
|
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 |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara.
Jalandhar
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
A Yashudas |
| Designation |
PG Student |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara.
Kapurthala
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
dr.anthoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University Faculty of Applied Medical Sciences |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara.
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Uni-Hospital, Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. PIN:144411 |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Chandra Patra |
| Address |
Block 4, Room no 105, department of Physiotherapy, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara. Punjab, India. PIN-144411 |
| 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 Ramesh Chandra Patra |
Lovely Professional University Faculty of Applied Medical Sciences |
Uni-Hospital, Block 4, Room no 105, department of Physiotherapy, Lovely Professional University.
Jalandhar
PUNJAB |
09653174563
ramesh.19500@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University, Punjab |
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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Craniofacial Manual Therapy (CFMT) alone |
Participants in the comparator (control) group will receive Craniofacial Manual Therapy (CFMT) alone for 6 weeks. This treatment will consist of myofascial release techniques aimed at relieving muscle tension and improving soft tissue mobility in the craniofacial and cervical regions, along with graded joint mobilizations of the temporomandibular joint (TMJ) and cervical spine to enhance joint function and reduce pain. Each CFMT session will last for 30 minutes and will be delivered twice weekly over a period of six weeks, totaling 12 sessions per participant. No electrical dry needling or auricular vagus nerve stimulation will be administered in this group. The purpose of providing only CFMT in the comparator group is to evaluate the additional therapeutic effect of adding Electrical Dry Needling Auricular Vagus Nerve Stimulation (eDN-aVNS) to standard manual therapy, by comparing outcomes such as headache intensity, temporomandibular function, and quality of life between the two groups. |
| Intervention |
Electrical Dry Needling Auricular Vagus Nerve Stimulation (eDN-aVNS) and Craniofacial Manual Therapy |
Total Duration of the treatment is 6 weeks. Participants in the experimental group will receive a combination of Electrical Dry Needling Auricular Vagus Nerve Stimulation (eDN-aVNS) and Craniofacial Manual Therapy (CFMT). For the eDN-aVNS intervention, sterile acupuncture needles will be inserted at specific auricular points corresponding to the auricular branch of the vagus nerve, primarily targeting the cymba conchae region of the ear. Once properly placed, electrical stimulation will be applied using a low-frequency electrical stimulator set to a frequency of 2 Hz and an intensity of 0.5 to 1 mA, providing mild but perceptible stimulation. Each stimulation session will last for 20 minutes. The eDN-aVNS procedure will be administered twice a week over a period of six weeks.
In addition to the electrical stimulation, participants will receive Craniofacial Manual Therapy (CFMT), designed to address musculoskeletal dysfunction contributing to symptoms. The CFMT intervention will consist of myofascial release techniques targeting tight and dysfunctional muscles in the craniofacial and cervical regions, along with graded joint mobilizations of the temporomandibular joint (TMJ) and cervical spine to improve joint mobility and reduce pain. Each CFMT session will last 30 minutes, and will also be administered twice weekly for six weeks, in parallel with the eDN-aVNS sessions.
This multimodal approach is designed to synergistically combine neuromodulation via auricular vagus nerve stimulation with mechanical correction and soft tissue release, aiming to improve pain, functional outcomes, and autonomic regulation in patients suffering from cervicogenic headache and temporomandibular disorders. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants eligible for the study must have a confirmed diagnosis of cervicogenic headache according to the International Classification of Headache Disorders criteria, as well as a diagnosis of temporomandibular disorders based on the DC/TMD criteria. They must have experienced chronic symptoms for at least three months and provided written informed consent to participate. |
|
| ExclusionCriteria |
| Details |
Individuals will be excluded if they have known contraindications to dry needling or manual therapy, suffer from severe systemic illness, are pregnant or lactating, have psychiatric disorders that may interfere with participation, or have experienced recent trauma or surgery in the craniofacial region within the last six months. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache Intensity
Measured using the Visual Analog Scale (VAS), assessed before and after the intervention to quantify the subjective intensity of cervicogenic headache.
Headache Frequency
Number of headache days per month, recorded using a headache diary, compared pre- and post-intervention.
Temporomandibular Joint Dysfunction
Assessed using the Helkimo Clinical Dysfunction Index, which evaluates TMJ function, joint sounds, range of motion, and pain.
Jaw Pain Intensity
Measured using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain possible), recorded pre- and post-intervention to assess changes in TMD-related pain.
Mouth Function
Assessed by the Mandibular Functional Impairment Questionnaire (MFIQ), which evaluates difficulty in performing functional activities such as chewing, speaking, yawning, and mouth opening. |
Baseline, 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pressure Pain Threshold (PPT)
Measured using an algometer at standardized points in the craniofacial and cervical regions to objectively quantify sensitivity and mechanical pain thresholds.
Autonomic Nervous System Balance
Evaluated via Heart Rate Variability (HRV) parameters, specifically SDNN (Standard Deviation of NN intervals) and RMSSD (Root Mean Square of Successive Differences), to assess vagal tone and autonomic function.
Quality of Life
Assessed using the SF-36 questionnaire, measuring overall physical and mental health status. |
Baseline, 6 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized controlled trial to evaluate the efficacy of combining electrical dry needling targeting the auricular branch of the vagus nerve with craniofacial manual therapy for the management of cervicogenic headache and temporomandibular disorders. Sixty adults aged 18 to 65 years diagnosed with both conditions will be randomly assigned to either an experimental group receiving combined therapy or a control group receiving craniofacial manual therapy alone. The intervention will be administered twice weekly for six weeks. Primary outcomes include headache intensity measured by visual analog scale, headache frequency, temporomandibular joint dysfunction assessed by the Helkimo index, jaw pain intensity, and mouth function assessed by the mandibular functional impairment questionnaire. Secondary outcomes include pressure pain threshold, autonomic nervous system balance assessed by heart rate variability parameters, and quality of life measured by SF36 questionnaire. Assessments will be conducted at baseline, after six weeks of intervention, and at twelve weeks follow-up to evaluate both immediate and long term effects. The study aims to determine whether the combined intervention provides superior outcomes compared to manual therapy alone. |