Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2023
Somatosensory Stimulation Therapy in Patients with Somatosensory Tinnitus: A Pilot Study.
Рандомизированное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Hong Guowei
Аннотация
OBJECTIVE: To explore the efficacy and safety of EMS (Exercise to improve muscle strength, Motion of joints, and Stretch training) in somatosensory tinnitus symptoms.
STUDY DESIGN: A randomized delayed-start controlled trial.
SETTING: At the Department of Otorhinolaryngology, Eye and Ear, Nose, and Throat Hospital between February 2019 and May 2019.
PATIENTS: Patients with somatosensory tinnitus.
INTERVENTIONS: In the immediate-start group, the participants received EMS somatosensory stimulation therapy for 3 weeks and were followed up for 3 weeks. In the delayed-start group, the participants first waited for 3 weeks and were treated with EMS somatosensory stimulation therapy for 3 weeks.
MAIN OUTCOME MEASURES: The primary endpoint was the changes in Tinnitus Handicap Inventory (THI) and the visual analog scale (VAS) scores after 3 weeks of treatment. The secondary endpoint was the proportion of patients achieving improvements in VAS and THI scores. THI and VAS were collected at baseline and at 3, 6, 9, and 12 weeks.
RESULTS: Sixty-four patients were randomized to the immediate-start group and delayed-start treatment with each 32. After the 3-week treatment, the immediate-start group showed significant lower in VAS (25.7 ± 3.3 versus 38.9 ± 5.8, p < 0.001) and THI (29.1 ± 5.1 versus 42.8 ± 6.6, p < 0.001). There were no differences in VAS and THI between the two groups after treatment (i.e., at weeks 6, 9, and 12). All patients were followed up for 6, 9, and 12 weeks, and the therapeutic effect was stable.
CONCLUSION: The EMS somatosensory stimulation therapy might be an effective and safe treatment for improving symptoms, and the therapeutic effect was still stable in 3, 6, 9, and 12 weeks.
CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR1900020746.
STUDY DESIGN: A randomized delayed-start controlled trial.
SETTING: At the Department of Otorhinolaryngology, Eye and Ear, Nose, and Throat Hospital between February 2019 and May 2019.
PATIENTS: Patients with somatosensory tinnitus.
INTERVENTIONS: In the immediate-start group, the participants received EMS somatosensory stimulation therapy for 3 weeks and were followed up for 3 weeks. In the delayed-start group, the participants first waited for 3 weeks and were treated with EMS somatosensory stimulation therapy for 3 weeks.
MAIN OUTCOME MEASURES: The primary endpoint was the changes in Tinnitus Handicap Inventory (THI) and the visual analog scale (VAS) scores after 3 weeks of treatment. The secondary endpoint was the proportion of patients achieving improvements in VAS and THI scores. THI and VAS were collected at baseline and at 3, 6, 9, and 12 weeks.
RESULTS: Sixty-four patients were randomized to the immediate-start group and delayed-start treatment with each 32. After the 3-week treatment, the immediate-start group showed significant lower in VAS (25.7 ± 3.3 versus 38.9 ± 5.8, p < 0.001) and THI (29.1 ± 5.1 versus 42.8 ± 6.6, p < 0.001). There were no differences in VAS and THI between the two groups after treatment (i.e., at weeks 6, 9, and 12). All patients were followed up for 6, 9, and 12 weeks, and the therapeutic effect was stable.
CONCLUSION: The EMS somatosensory stimulation therapy might be an effective and safe treatment for improving symptoms, and the therapeutic effect was still stable in 3, 6, 9, and 12 weeks.
CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR1900020746.