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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
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniomandibular Dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 17, 2013
Last Updated
December 2, 2014
Sponsor
Heidelberg University
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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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