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  • Patient education and self-care for the management of jaw pain upon awakening: a randomized controlled clinical trial comparing the effectiveness of adding pharmacologic treatment with cyclobenzaprine or tizanidine.

Patient education and self-care for the management of jaw pain upon awakening: a randomized controlled clinical trial comparing the effectiveness of adding pharmacologic treatment with cyclobenzaprine or tizanidine.

Journal of oral & facial pain and headache (2014-05-14)
Francisco Guedes Pereira Alencar, Patricia Gabriela Viana, Camila Zamperini, Anne Becker
ABSTRACT

To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening. Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study. The subjects were randomly assigned into one of three groups: placebo group, TZA group (tizanidine 4 mg), or CYC group (cyclobenzaprine 10 mg). Patients were evaluated for changes in pain intensity, frequency, and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index. Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate. All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores. However, no significant differences among the groups were observed at the posttreatment evaluation. The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Amitriptyline hydrochloride, ≥98% (TLC), powder
Ibuprofen for peak identification, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Cyclobenzaprine hydrochloride
Supelco
Amitriptyline hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Ibuprofen, Pharmaceutical Secondary Standard; Certified Reference Material
Amitriptyline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Cyclobenzaprine hydrochloride, European Pharmacopoeia (EP) Reference Standard
USP
Ibuprofen, United States Pharmacopeia (USP) Reference Standard
Ibuprofen, European Pharmacopoeia (EP) Reference Standard
USP
Amitriptyline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Supelco
Ibuprofen
Sigma-Aldrich
Ibuprofen, meets USP testing specifications
Sigma-Aldrich
Ibuprofen, ≥98% (GC)
Supelco
Ibuprofen sodium salt, ≥98% (GC)
Supelco
Amitriptyline hydrochloride solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Supelco
Cyclobenzaprine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®
Supelco
Clonidine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Sigma-Aldrich
(S)-(+)-Ibuprofen, ReagentPlus®, 99%
Supelco
Ibuprofen solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®