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IRCT20210411050928N1 IRCT 2021-05-02 Mashhad University of Medical Sciences The effect of acupuncture on the intensity of sounds heard and quality of life in patients with chronic non-pulsating tinnitus The effect of acupuncture on the intensity of sounds heard and quality of life in patients with chronic non-pulsating tinnitus 2021-04-11 anticipated 30 Complete https://irct.ir/trial/55513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients, with the help of a sequence of random numbers extracted from the computer (via the website www.randomization.com) and by simple randomization were divided into two groups of control (placebo) and intervention (acupuncture). The resulting random numbers and the fact that patients were assigned to groups were concealed with the help of sealed envelopes, Blinding description: Patients participating in the study do not know in which intervention or control group they were placed. Patients are randomly assigned to one of the two groups of acupuncture (case) and placebo (control), using four randomly fixed blocks. The analyzer does not know the type of intervention. 2-3 Tinnitus. Intervention 1: Intervention group: Appropriate acupuncture points are selected for the treatment of tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, and patients receive 12 sessions of acupuncture (3 times a week). Acupuncture is performed by an acupuncturist (B.N.) in specific areas. The needles used were filament types with very fine and flexible filaments. The size of the metal needle is 40 by 25 mm. The needles are placed vertically without anesthesia. Intervention 2: Control group: People in areas suitable for acupuncture to treat tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, are treated with placebo needles without affecting tinnitus. These placebo needles do not penetrate the skin and are completely painless and harmless. The position of the patients and the preparation process are similar to the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Afsaneh Mohammadpoor Maleki
No. 12 , Vakilabad Ave, No 28.
Mashhad Iran (Islamic Republic of) 9178866352 +98 51 3891 0728 mohammadpoura961@mums.ac.ir Mashhad University of Medical Sciences scientific Afsaneeh Mohammadpoor Maleki
Ghaem Hospital, Ahmadabad Ave.
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3841 3492 mohammadpoura961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) chronic non-pulsating tinnitus 40 years 65 years Both Pulsating tinnitus having Titinus with Meniere's disease and other types of vertigo, vestibular schwannoma, otosclerosis, conductive hearing loss pregnancy mental disorders that make it difficult for the patient to answer the questionnaire H93.1 Tinnitus Treatment - Other Treatment - Other Intervention group: Appropriate acupuncture points are selected for the treatment of tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, and patients receive 12 sessions of acupuncture (3 times a week). Acupuncture is performed by an acupuncturist (B.N.) in specific areas. The needles used were filament types with very fine and flexible filaments. The size of the metal needle is 40 by 25 mm. The needles are placed vertically without anesthesia. Control group: People in areas suitable for acupuncture to treat tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, are treated with placebo needles without affecting tinnitus. These placebo needles do not penetrate the skin and are completely painless and harmless. The position of the patients and the preparation process are similar to the intervention group. Tinnitus volume. Timepoint: At the beginning of the study and after the end of the treatment period, all patients complete the THI questionnaire. Method of measurement: Tinnitus Handicap Inventory ( THI ) and Visual-analogue scale (VAS) questionnaire. Mashhad University of Medical Sciences Approved 2019-08-13 Ethics committee of mashhad University of Medical Sciences No. 12, Vakilabad Ave, No. 28 Mashhad Razavi Khorasan Iran (Islamic Republic of)