The effectiveness of adding pharmacologic treatment with clonazepam or cyclobenzaprine to patient education and self-care for the treatment of jaw pain upon awakening: a randomized clinical trial.
OBJECTIVE
To compare the relative effectiveness of a benzodiazepine (clonazepam), a muscle relaxant (cyclobenzaprine), and a placebo for the treatment of jaw pain upon awakening, when each is combined with the recommended nonpharmacological components of initial medical management.


METHODS
Forty-one subjects were recruited with a diagnosis of myofascial pain based on the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). All subjects were given education about TMD and a self-care program. Subjects were randomized into 1 of 3 groups: clonazepam (0.5 mg/night), cyclobenzaprine (10 mg/night), or placebo. The primary outcome measure was the subjects' average intensity of jaw pain upon awakening over the prior week. This was recorded with a visual analog scale at pretreatment and at the completion of the 3-week trial. A secondary outcome measure was sleep quality based on the Pittsburg Sleep Quality Index.


RESULTS
Within-group changes showed a statistically significant (P < .001) decrease in jaw pain upon awakening for all 3 groups. Between-group differences demonstrated a statistically significant difference (P < .016) between cyclobenzaprine and placebo, and between cyclobenzaprine and clonazepam. There was no significant effect on sleep quality in any group.


CONCLUSIONS
This study suggests that cyclobenzaprine is statistically superior to either placebo or clonazepam when added to self-care and education for the management of jaw pain upon awakening. Based on the subjects' report of sleep quality, these medications failed to significantly improve sleep in the short term.
Herman
Cory R
CR
University of Minnesota, School of Dentistry, TMJ/Orofacial Pain Division, 6-320 Moos Health Science Tower, 515 Delaware Street South East, Minneapolis, MN 55455, USA. herm0024@gold.tc.umn.edu
Schiffman
Eric L
EL
Look
John O
JO
Rindal
D Brad
DB
D000328:Adult; D000639:Amitriptyline / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D002998:Clonazepam / Q000627:therapeutic use*; D005260:Female; D018757:GABA Modulators / Q000627:therapeutic use*; D006267:Health Education, Dental; D006801:Humans; D008297:Male; D009125:Muscle Relaxants, Central / Q000627:therapeutic use*; D012648:Self Care; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013706:Temporomandibular Joint Dysfunction Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
D018757:GABA Modulators; D009125:Muscle Relaxants, Central; D000639:Amitriptyline; D002998:Clonazepam; C004704:cyclobenzaprine