NCT01502709

Brief Summary

The investigators propose to conduct a randomized blinded placebo-controlled clinical trial in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and symptoms of TMD, and any adverse events.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

December 6, 2011

Results QC Date

August 2, 2013

Last Update Submit

April 25, 2016

Conditions

Temporomandibular Joint Disorders

Keywords

Single blindRandomizedControlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment

    The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.

    Daily Self-reports at Baseline and on Days 1 through 7

Secondary Outcomes (2)

  • Mean Percentage of Time Spent in Pain From Days 1-7

    Days 1-7

  • Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam

    Baseline, Month 3

Study Arms (2)

Caloric Vestibular Neurostimulation

EXPERIMENTAL

Subjects received caloric vestibular neurostimulation

Device: Caloric Vestibular Neurostimulation

Placebo Arm

PLACEBO COMPARATOR

Subjects received placebo

Device: placebo

Interventions

Caloric Vestibular NeurostimulationDEVICE

1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear

Caloric Vestibular Neurostimulation
placeboDEVICE

Matching placebo device

Placebo Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65 years
  • English speaking
  • Females with chronic TMD

You may not qualify if:

  • History of any of the following: Terminal, progressive and /or unstable medical illness; Previous head or neck surgery for neoplasm; current chemotherapy or radiation therapy; facial trauma or orofacial surgery within the last 6 weeks; seizures, history of drug or alcohol abuse; Otologic disorders including chronic vertigo, chronic tinnitus, otitis external, otitis media, mastoiditis and tympanic membrane perforation; Stroke, transient ischemia attacks or Arnold- Chiari malformation; significant cardiac or respiratory disease; epilepsy or neurological disorders such as dementia, brain injury, and brain tumor
  • Subjects who score ≥ 31 on the Becks depression inventory (performed at first appointment)
  • History of or current destructive nerve therapies, defibrillator, pacemakers, deep brain stimulator, or Implantable nerve stimulators
  • Utilization of other alternative or complementary therapies during the study period
  • Participation in a clinical trial involving the use of a clinical devise in the last 30 days
  • Women who are currently pregnant or nursing.
  • Patients who are left handed.
  • Current orthodontic treatment.
  • Use of an opiate in the 48 hour period preceding the baseline study visit
  • The use of anti-histamines 6 hours before, during or immediately after the treatment period
  • The use of anti-nausea or anti-vertigo drugs 6 hours before or during the treatment period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr Asma Khan
Organization
University of North Carolina
asma_khan@dentistry.unc.edu
919 537 3389

Study Officials

  • Asma Khan, BDS, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor UNC School of Dentistry

Study Record Dates

First Submitted

December 6, 2011

First Posted

January 2, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 26, 2016

Results First Posted

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)