Status:
TERMINATED
Neurostimulation in Temporomandibular Disorders (TMD) Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Temporomandibular Joint Disorders
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 (...
Detailed Description
Temporomandibular disorders (TMD) are musculoskeletal pain conditions characterized by pain in the temporomandibular joint and/or the masticatory muscles. TMD are amongst the most common chronic muscu...
Eligibility Criteria
Inclusion
- Aged 18-65 years
- English speaking
- Females with chronic TMD
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01502709
Start Date
December 1 2011
End Date
March 1 2012
Last Update
April 26 2016
Active Locations (1)
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1
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States, 27599