Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

Orofacial Pain Clinical Trial

Official title:

Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949064
• Other study ID #: BioGC1UHeidelberg
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2013
• Last updated: December 2, 2014
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.

Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent form

• Age between 18 and 70 years

• Non-chronic painful CMD with/without mandibular movement restriction

• Female

Exclusion Criteria:

• Pregnancy or breastfeeding

• Chronic Pain Status higher than 2

• Known allergic reaction against the gel pads

• Electronic implants (pacemaker, defibrilator, insulin pump)

• Facial pain of dental or neuropathic etiology

• Traumatic injuries of the face / operations

• Dental treatment need

• Problems with swallowing reflex

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniomandibular Disorders
• Craniomandibular Dysfunction
• Orofacial Pain

Intervention

Device:
• Grindcare

• Michigan-type occlusal splint

Locations

Country	Name	City	State
Germany	Poliklinik für Zahnärztliche Prothetik	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst perceived pain		1 week	No