N/A
N=24
Motor Cortex as a Research & Therapeutic Target in TMD
Temporomandibular Joint Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02247063 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline — 4; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline |
4; 9 | — |
| SECONDARY Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline |
4; 9 | — |
Summary
The investigators are doing a study to learn about the effects of a type of low-energy non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints. Disorders in these joints are called temporomandibular joint disorders, or TMD.
Eligibility Criteria
Inclusion Criteria
- Daily chronic TMD pain and dysfunction for at least one year (Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I Group I: Myofascial pain diagnosis[15]) not adequately controlled by previous conventional therapies (TMJ open-surgery naïve) for more than
1 year
- Self-reported pain score of at least 3 on a 0-10 scale in spite of existing treatment in the two weeks preceding the onset of the study
- Taking stable doses of medications for at least 4 weeks (if taking medications), and willing to limit the introduction of new medications for chronic TMD symptoms during the study
Exclusion Criteria
- Pain not primarily due to TMD
- History or current evidence of a psychotic disorder (e.g. schizophrenia) or substance abuse by DSM-IV criteria; bipolar or severe major depression
- History of neurological disorder (e.g. epilepsy, stroke, neuropathy, neuropathic pain)
- Any severe clinical condition that in the opinion of the principal investigator interferes with the study
- Pregnant or expecting to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT02247063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.