Use of Electromyography With Bio-Feedback for the Treatme... | NCT01949064

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

NCT01949064

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

44Actual

Phase

Phase 2

Conditions

Craniomandibular Dysfunction
Orofacial Pain

Interventions

Grindcare
Michigan-type occlusal splint

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 17, 2013

First Submission Date that Met QC Criteria

Sep 23, 2013

First Posted Date

Sep 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Michigan-type occlusal splint	Active Comparator	Occlusal splint, Michigan-type	Device: Michigan-type occlusal splint
Grindcare	Active Comparator	Biofeedback device	Device: Grindcare

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grindcare	Device		Grindcare
Michigan-type occlusal splint

Measure	Description	Time Frame
Worst perceived pain		1 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc	Poliklinik für Zahnärztliche Prothetik	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poliklinik für Zahnärztliche Prothetik		Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005157	Facial Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided