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Clinical Trials/CTRI/2025/09/094020
CTRI/2025/09/094020
Not yet recruiting
Not Applicable

Effects of a Multimodal Intervention Combining Cranio-Cervicomyofascial Release, Transcutaneous Auricular Vagus Nerve Stimulation, and Exercise on Pain, Oral Function, Oral Health–Related Quality of Life, and Headache in Patients With Temporomandibular Disorders

Lovely Professional University1 site in 1 country40 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
Pain intensity

Overview

Brief Summary

Temporomandibular disorders (TMD) affect 5–12% of the population and are a leading cause of chronic orofacial pain, impaired jaw function, and reduced oral health–related quality of life (OHRQoL). TMD is often associated with cervicogenic headache, neck dysfunction, and psychosocial distress, making management complex.

Conservative treatments, including manual therapy, exercise, and behavioral interventions, are recommended as first-line care. However, emerging therapies such as cranio-cervicomyofascial release (CCMR) and transcutaneous auricular vagus nerve stimulation (taVNS) show promise for pain modulation, autonomic regulation, and functional recovery.

To date, no study has examined the combined effects of CCMR, taVNS, and exercise as a multimodal intervention for TMD. This study addresses that gap by testing an integrated approach targeting musculoskeletal, neurological, and functional components of TMD.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed with TMD per TMD criteria.
  • Reported pain for more than 3 months.
  • Willingness to attend all treatment sessions.

Exclusion Criteria

  • History of major jaw surgery, fractures, or inflammatory joint disease any Neurological disorders contraindicating vagus nerve stimulation and Pregnancy or other medical contraindications.

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Baseline, Post, 3 months

Secondary Outcomes

  • Oral function, OHRQoL, OHRQoL, Headache severity/frequency(Baseline, Post, 3 months)

Investigators

Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ramesh Chandra Patra

Lovely Professional University Faculty of Applied Medical Sciences

Study Sites (1)

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