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

NCT01949064 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-12-03

No results posted yet for this study

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.

Conditions

  • Craniomandibular Dysfunction
  • Orofacial Pain

Interventions

DEVICE

Grindcare

DEVICE

Michigan-type occlusal splint

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc · Poliklinik für Zahnärztliche Prothetik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949064 on ClinicalTrials.gov