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

Phase 2

Completed

• Conditions: Craniomandibular Dysfunction; Orofacial Pain
• Interventions: Device: Michigan-type occlusal splint; Device: Grindcare

• Registration Number: NCT01949064
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Michigan-type occlusal splint	Michigan-type occlusal splint	Occlusal splint, Michigan-type
Grindcare	Grindcare	Biofeedback device

Primary Outcome Measures

Name	Time	Method
Worst perceived pain	1 week

Trial Locations

Locations (1)

Poliklinik für Zahnärztliche Prothetik; 🇩🇪 Heidelberg, Germany