Effects of massage therapy and occlusal splint therapy on electromyographic activity and the intensity of signs and symptoms in individuals with temporomandibular disorder and sleep bruxism: a randomized clinical trial

Background Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. Objective The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. Methods An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. Results Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=–2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=–2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=–3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001). Conclusions This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. Trial Registration ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762

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Effect of Silymarin in the Treatment of Allergic Rhinitis

Otolaryngology ◽

10.1177/0194599811423504 ◽

2011 ◽

Vol 145 (6) ◽

pp. 904-909 ◽

Cited By ~ 10

Author(s):

Mehdi Bakhshaee ◽

Farahzad Jabbari ◽

Saeed Hoseini ◽

Reza Farid ◽

Mohammad Hadi Sadeghian ◽

...

Keyword(s):

Clinical Trial ◽

Allergic Rhinitis ◽

Randomized Clinical Trial ◽

Signs And Symptoms ◽

Study Group ◽

Positive Skin Prick Test ◽

Serum Ige ◽

Oxidative Stresses ◽

The Impact

Objective. Although the role of oxidative stresses has been confirmed in the pathophysiology of allergic rhinitis and the protective effect of silymarin against oxidative stresses has been proven in different organs, no study has yet been conducted on the impact of silymarin on allergic rhinitis treatment. Study Design. A randomized clinical trial study. Setting. Two tertiary referral centers with otorhinolaryngology–head and neck surgery and allergy and immunology departments. Patients and Methods. In a randomized clinical trial, 94 patients with the signs and symptoms of allergic rhinitis and a positive skin prick test were selected and randomly divided into 2 groups. Their signs and symptoms, eosinophil percentage on nasal smear, serum IgE, and interleukin (IL-4, IL-5, interferon-γ) levels were recorded. The study group was treated with silymarin, whereas the control group received placebo, both for 1 month, along with routine antihistamine treatment. At the end of the treatment course, clinical and laboratory findings were statistically analyzed. Results. Sixty patients completed the trial. Based on the Sino-Nasal Outcome Test 20 (SNOT-20), a significant improvement in clinical symptom severity was observed in both groups (9.23 ± 5.14 vs 2.20 ± 2.69; P < .001), which was statistically significantly higher in the study group ( P < .001). Posttreatment percentage of nasal eosinophils and cytokine levels showed no significant difference ( P > .05). Rise in serum IgE level was seen after treatment with silymarin ( P = .003). Conclusion. Considering the statistically effective role of silymarin in alleviating the severity of allergic rhinitis symptoms, applying this herbal antioxidant along with other medications may result in better management.

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