Ricerc@Sapienza

Background: Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, chewing muscle, and surrounding structures. Laserneedle acupuncture (LNA), a nonthermal and low-intensity laser irradiation used to stimulate acupoints, has been reported as effective for treating chronic musculoskeletal disorders, including TMD, but a lack of well-designed randomised controlled trials (RCTs) means there is insufficient evidence to prove the efficacy of LNA.
Methods: this study is a two-arm parallel, assessor-blinded, randomised controlled trial. We will enrol 40 chronic TMD patients from the Clinical Gnathology Unit of Sapienza University of Rome according to DC/TMD diagnostic criteria, and randomly allocate 20 patients each to an LNA group and a conventional gnathological therapy group (CT). The LNA treatment will be administered in 8 sessions, twice a week for 4 weeks. The CT group will undergo the conventional gnathological treatment (occlusal device) and will be visited after 4 weeks from the start of therapy. For both groups there will be a follow-up visit 8 weeks from baseline. The primary outcome is the difference in Verbal Numeric Scale (VNS) score for TMD pain between baseline and week 4. Secondary outcomes will be temporomandibular joint range of motion, the Italian version of Beck's Depression Index-II (BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life (validated questionnaire). Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis.
Purposes: this study will assess the efficacy and safety of LNA compared with CT for improving pain, functional/emotional impairment and quality of life in chronic TMD patients. This RCT will provide evidence for the efficacy, safety, and economics of LNA.