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

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.

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Key information

Conditions

Craniomandibular Dysfunction Facial Pain Neurologic Manifestations Orofacial Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Poliklinik für Zahnärztliche Prothetik

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grindcare

Device

Michigan-type occlusal splint

Device

Primary outcomes

Worst perceived pain

Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 24, 2013
Registry last updated: Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed