Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Primary Purpose
Craniomandibular Dysfunction, Orofacial Pain
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Grindcare
Michigan-type occlusal splint
Sponsored by
About this trial
This is an interventional treatment trial for Craniomandibular Dysfunction
Eligibility 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
Sites / Locations
- Poliklinik für Zahnärztliche Prothetik
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Michigan-type occlusal splint
Grindcare
Arm Description
Occlusal splint, Michigan-type
Biofeedback device
Outcomes
Primary Outcome Measures
Worst perceived pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01949064
First Posted
September 17, 2013
Last Updated
December 2, 2014
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01949064
Brief Title
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Official Title
Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniomandibular Dysfunction, Orofacial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Michigan-type occlusal splint
Arm Type
Active Comparator
Arm Description
Occlusal splint, Michigan-type
Arm Title
Grindcare
Arm Type
Active Comparator
Arm Description
Biofeedback device
Intervention Type
Device
Intervention Name(s)
Grindcare
Intervention Type
Device
Intervention Name(s)
Michigan-type occlusal splint
Primary Outcome Measure Information:
Title
Worst perceived pain
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc
Organizational Affiliation
Poliklinik für Zahnärztliche Prothetik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinik für Zahnärztliche Prothetik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
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