Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265636
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-16
Brief Title:
Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders
Sponsor:
OrigenKinesis fisioterapia
Organization:
OrigenKinesis fisioterapia
Study Overview
Official Title:
Transcutaneous Mandibular Nerve Electrical Stimulation for the Management of Pain and Function in Patients With Temporomandibular Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Origenkine
Brief Summary:
Temporomandibular disorders TMD encompass dysfunction and pain of the masticatory muscles and temporomandibular joint TMJ Pain in the TMJ restricted jaw movement and joint sounds are common conditions in this disorder This can impact patients ability to perform daily activities such as eating speaking laughing or yawning significantly affecting their quality of life
The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve V3 a branch of the trigeminal nerve An estimated 60 to 70 of the population shows signs of TMD of which up to 12 report intense symptoms requiring treatment
Percutaneous electrical nerve stimulation PENS could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy To our knowledge there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve
The projects objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition
The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve V3 a branch of the trigeminal nerve An estimated 60 to 70 of the population shows signs of TMD of which up to 12 report intense symptoms requiring treatment
Percutaneous electrical nerve stimulation PENS could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy To our knowledge there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve
The projects objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition
Detailed Description:
Pain is the most common and limiting feature of Temporomandibular Disorders TMD affecting approximately 75 of the population at some point in life These disorders involve dysfunction and pain in the masticatory muscles and temporomandibular joint impacting patients quality of life An estimated 60-70 of the population shows signs of TMD with up to 12 requiring treatment The peak incidence occurs between 20 and 40 years predominantly affecting women 81 compared to men
Temporomandibular Disorder often coexists with other medical conditions such as headaches The most common diagnoses are myofascial pain followed by disc displacement with reduction and arthralgia Prevalence ranges from 3 to 15 with new case rates between 2 and 4 Prognosis for myofascial TMD varies with studies indicating persistence remission and relapse
The economic cost associated with TMD is significant with studies revealing considerable expenses on treatments The multifactorial pathophysiology of myofascial pain is influenced by bruxism stress psychological conditions and fibromyalgia Risk factors include genetics psychological stress and parafunctional habits Clinical manifestations include pain decreased jaw mobility and additional symptoms in the head and neck Diagnosis involves physical examination palpation of muscles and joints and imaging tests such as magnetic resonance imaging Specific diagnostic criteria have been proposed
Conservative treatment including physiotherapy manual therapy exercises splints and pharmacological modalities is the primary option However there are limitations in the effectiveness of some approaches Physiotherapy is considered effective by 72 of respondents in the United Kingdom
The musculoskeletal system related to the temporomandibular joint TMJ consists of masticatory facial expression and neck muscles playing specific roles in jaw movement Elevator muscles masseter temporal and medial pterygoid close the mouth depressors digastric and lateral pterygoid open it protractors temporal and lateral pterygoid move it forward and retractors masseter and medial pterygoid move it backward Facial expression and neck muscles contribute to additional functions
Motor innervation of the TMJ comes from the trigeminal nerve specifically its mandibular branch V3 which also innervates masticatory muscles This nerve divides into branches such as the ophthalmic maxillary and mandibular providing sensitivity to different areas of the face mouth and jaw
Blood supply to the TMJ occurs through the superficial temporal artery and the mandibular artery supplying blood to the skin muscles and surrounding joint structures
Regarding the biomechanics and functionality of the TMJ its complexity and crucial role in jaw movements such as chewing speaking and yawning are emphasized
Manual therapy specifically cervico-mandibular therapy has shown significant improvements in disability related to temporomandibular disorders TMD The combination of manual therapy for the orofacial region and the cervical spine has proven to be more effective than home exercises or cervical treatment alone
Therapeutic exercise in the TMJ has demonstrated moderate short-term effects and variable long-term effects in reducing pain and improving range of motion in patients with TMJ dysfunction Passive and active stretches as well as postural exercises are useful for increasing range of motion and reducing pain
Percutaneous electrical nerve stimulation PENS emerges as a relevant option for managing pain in TMD patients PENS applied through ultrasound-guided needles can influence orofacial pain and jaw movement offering analgesic benefits through peripheral and central mechanisms PENS is considered a minimally invasive intervention and has been successfully used in chronic pain treatment
In summary a detailed understanding of the anatomy function innervation and vascularization of the TMJ combined with therapeutic approaches such as manual therapy exercise and PENS is essential for comprehending and effectively addressing temporomandibular disorders
Temporomandibular Disorder often coexists with other medical conditions such as headaches The most common diagnoses are myofascial pain followed by disc displacement with reduction and arthralgia Prevalence ranges from 3 to 15 with new case rates between 2 and 4 Prognosis for myofascial TMD varies with studies indicating persistence remission and relapse
The economic cost associated with TMD is significant with studies revealing considerable expenses on treatments The multifactorial pathophysiology of myofascial pain is influenced by bruxism stress psychological conditions and fibromyalgia Risk factors include genetics psychological stress and parafunctional habits Clinical manifestations include pain decreased jaw mobility and additional symptoms in the head and neck Diagnosis involves physical examination palpation of muscles and joints and imaging tests such as magnetic resonance imaging Specific diagnostic criteria have been proposed
Conservative treatment including physiotherapy manual therapy exercises splints and pharmacological modalities is the primary option However there are limitations in the effectiveness of some approaches Physiotherapy is considered effective by 72 of respondents in the United Kingdom
The musculoskeletal system related to the temporomandibular joint TMJ consists of masticatory facial expression and neck muscles playing specific roles in jaw movement Elevator muscles masseter temporal and medial pterygoid close the mouth depressors digastric and lateral pterygoid open it protractors temporal and lateral pterygoid move it forward and retractors masseter and medial pterygoid move it backward Facial expression and neck muscles contribute to additional functions
Motor innervation of the TMJ comes from the trigeminal nerve specifically its mandibular branch V3 which also innervates masticatory muscles This nerve divides into branches such as the ophthalmic maxillary and mandibular providing sensitivity to different areas of the face mouth and jaw
Blood supply to the TMJ occurs through the superficial temporal artery and the mandibular artery supplying blood to the skin muscles and surrounding joint structures
Regarding the biomechanics and functionality of the TMJ its complexity and crucial role in jaw movements such as chewing speaking and yawning are emphasized
Manual therapy specifically cervico-mandibular therapy has shown significant improvements in disability related to temporomandibular disorders TMD The combination of manual therapy for the orofacial region and the cervical spine has proven to be more effective than home exercises or cervical treatment alone
Therapeutic exercise in the TMJ has demonstrated moderate short-term effects and variable long-term effects in reducing pain and improving range of motion in patients with TMJ dysfunction Passive and active stretches as well as postural exercises are useful for increasing range of motion and reducing pain
Percutaneous electrical nerve stimulation PENS emerges as a relevant option for managing pain in TMD patients PENS applied through ultrasound-guided needles can influence orofacial pain and jaw movement offering analgesic benefits through peripheral and central mechanisms PENS is considered a minimally invasive intervention and has been successfully used in chronic pain treatment
In summary a detailed understanding of the anatomy function innervation and vascularization of the TMJ combined with therapeutic approaches such as manual therapy exercise and PENS is essential for comprehending and effectively addressing temporomandibular disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None