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

This study has been completed.
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, Heidelberg University Identifier:
First received: September 17, 2013
Last updated: December 2, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Craniomandibular Dysfunction Orofacial Pain Device: Grindcare Device: Michigan-type occlusal splint Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.

Resource links provided by NLM:

Further study details as provided by Giannakopoulos Nikolaos, Heidelberg University:

Primary Outcome Measures:
  • Worst perceived pain [ Time Frame: 1 week ]

Enrollment: 44
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Michigan-type occlusal splint
Occlusal splint, Michigan-type
Device: Michigan-type occlusal splint
Active Comparator: Grindcare
Biofeedback device
Device: Grindcare


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01949064

Poliklinik für Zahnärztliche Prothetik
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Nikolaos Nikitas Giannakopoulos,,M.Sc Poliklinik für Zahnärztliche Prothetik
  More Information

Responsible Party: Giannakopoulos Nikolaos,, M.Sc., Heidelberg University Identifier: NCT01949064     History of Changes
Other Study ID Numbers: BioGC1UHeidelberg
Study First Received: September 17, 2013
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Facial Pain
Craniomandibular Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents processed this record on September 21, 2017