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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01949064
First received: September 17, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Heidelberg University:

Primary Outcome Measures:
  • Worst perceived pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949064

Contacts
Contact: Nikolaos Nikitas Giannakopoulos, Dr.med.dent., M.Sc. nik.giannakopoulos@med.uni-heidelberg.de

Locations
Germany
Poliklinik für Zahnärztliche Prothetik Recruiting
Heidelberg, Germany, 69120
Contact: Nikolaos Giannakopoulos       nik.giannakopoulos@med.uni-heidelberg.de   
Contact: , Deutschland         
Sub-Investigator: Lydia Eberhard, Dr.med.dent.         
Sub-Investigator: Marc Schmitter, Professor, Dr.med.dent.         
Sub-Investigator: Michael Leckel, Dr.med.dent.         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Nikolaos Nikitas Giannakopoulos, 'Dr.med.dent., M.Sc. Poliklinik für Zahnärztliche Prothetik
  More Information

No publications provided

Responsible Party: Giannakopoulos Nikolaos, Dr.med.dent., M.Sc., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01949064     History of Changes
Other Study ID Numbers: BioGC1UHeidelberg
Study First Received: September 17, 2013
Last Updated: September 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Mandibular Diseases
Craniomandibular Disorders
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014