Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 3, 2014
December 1, 2014
2.5 years
September 17, 2013
December 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Worst perceived pain
1 week
Study Arms (2)
Michigan-type occlusal splint
ACTIVE COMPARATOROcclusal splint, Michigan-type
Grindcare
ACTIVE COMPARATORBiofeedback device
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent form
- Age between 18 and 70 years
- Non-chronic painful CMD with/without mandibular movement restriction
- Female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poliklinik für Zahnärztliche Prothetik
Heidelberg, 69120, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc
Poliklinik für Zahnärztliche Prothetik
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med.dent., M.Sc.
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 24, 2013
Study Start
July 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12