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Effect of Ear Electrical Dry Needling and Face/Neck Manual Therapy on Headache and Jaw Pain in Adults

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 - NILL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095001
Enrollment
60
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: 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

Sponsors

Dr Ramesh Chandra Patra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline, 6 weeks and 12 weeks

Secondary

MeasureTime frame
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.Timepoint: Baseline, 6 weeks and 12 weeks

Countries

India

Contacts

Public ContactDr Ramesh Chandra Patra

Lovely Professional University Faculty of Applied Medical Sciences

dr.anthoni@gmail.com09653174563

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026