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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01949064
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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.
Study Start Date : July 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Michigan-type occlusal splint
Occlusal splint, Michigan-type
Device: Michigan-type occlusal splint
Active Comparator: Grindcare
Biofeedback device
Device: Grindcare

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01949064

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

Responsible Party: Giannakopoulos Nikolaos,, M.Sc., Heidelberg University Identifier: NCT01949064     History of Changes
Other Study ID Numbers: BioGC1UHeidelberg
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 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