BACKGROUND: Temporomandibular joint disorders (TMDs) are collective terms for a series of clinical diseases. However, due to the complexity of the temporomandibular joint (TMJ), TMDs are still unknown as to their pathogenesis. OBJECTIVE: This pilot randomized controlled trial aimed to evaluate the efficacy of extracorporeal shock wave therapy (ESWT) in conjunction with drug therapy for myogenic TMDs. METHODS: In accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines, we conducted a randomized controlled trial involving 60 patients diagnosed with myogenic TMDs. Patients with myogenic TMDs (Class I) were randomly divided into ESWT group and Ultrashort Wave (UW) group. The UW group was given ultrashort wave combined with drug therapy, while the ESWT group was given extracorporeal shock wave combined with drug therapy. The primary outcome was pain intensity measured by the Visual Analog Scale (VAS), and secondary outcomes included maximum mouth opening (MMO) and temporomandibular joint function indices. RESULTS: Post-treatment assessments revealed significant improvements in VAS scores and MMO in both groups (p < 0.05). Besides, compared with the UW group, the VAS score, the degree of MMO and Friction indexes of the TMDs patients in the ESWT group were remarkably improved after treatment (p < 0.05). CONCLUSION: For TMDs patients, extracorporeal shock wave combined with drug therapy can more quickly and effectively relieve the pain of the patient and improve the patient's dysfunction. However, due to the limitations of a small sample size and lack of prospective registration, these findings should be interpreted with caution. Future studies with larger sample sizes and proper registration are warranted.

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