Reducing chronic pain in participants with temporomandibular disorders Oral Health
Conditions
Interventions
This is a free-choice, randomized, cross-over design study lasting a total of 90 days, with two periods of 45 days. At informed consent, participants choose whether they want to take open-label placeb
Sponsors
University of Maryland, Baltimore
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fluency in English 2. Aged between 18 and 70 years old 3. Having TMD for more than 3 months
Exclusion criteria
Exclusion criteria: 1. The presence of degenerative neuromuscular disease 2. Untreated cardiovascular disease 3. Neurological disease 4. Severe psychosis such as mania, bipolar disorders, and schizophrenia (self or first order family members) 5. A positive toxicology test result on opioid, cocaine, amphetamine, and methamphetamine will disqualify the participant because the use of those illicit medications might alter the placebo responses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured using a 0 to 100 Visual Analog Scale (VAS), with 0=no pain at all to 100=maximum tolerable pain, daily for 90 days, with 3-, 4-, and 6-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed for 90 days, with 3-, 4-, and 6-month follow-up: 1. Pain unpleasantness, mood, and anxiety measured using a 0 to 100 VAS, with 0=no unpleasantness at all/worst mood/not anxious to 100=maximum unpleasant/best mood/most anxious, daily 2. Pain interference, pain behavior, anxiety, depression, and sleep disturbance measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) weekly 3. Expectations measured using a 0 to 100 VAS with the question "how much pain relief do you expect due to the intervention?" weekly | — |
Countries
United States of America
Contacts
Public ContactLuana Colloca
Outcome results
None listed