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IRCT20110809007265N14 IRCT 2023-11-01 Mashhad University of Medical Sciences Evaluation and comparison of the effects of electroacupuncture and manual acupuncture on uterine fibroids Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on symptoms, mass size and doppler indices of uterine arteries in patients with uterine fibroids 2023-11-01 anticipated 72 Complete https://irct.ir/trial/71315 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type: Block The method used to generate the random allocation sequence: envelope method: The envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com site, and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then the purpose of the study will be explained to the person who meets the stated conditions, and if the person wishes to continue, he will sign the informed consent form and pick an envelope, then opens it, and based on the contents of the envelope, the person will be entered into the intervention or control group. Allocation Concealment method: Numbered sealed envelopes After randomly assigning each patient to one of the groups, the name of the patient and the corresponding group is recorded in a book by the allocator who will not be among the evaluators, Blinding description: The patients are blinded in all stages of the intervention and do not know which group they have participated in. The main researcher who performs acupuncture knows the group of patients because the treatment protocol of each group is different from the other group. The statistical researcher and analyzer, the radiologist who performs ultrasound Doppler and the gynecologist, who is responsible for the initial diagnosis of patients and their referral, are also blind to the groups. 3 Leiomyoma. Intervention 1: First Intervention group: In the segmental electroacupuncture group, after inserting the needles in their predefined acupoints (two points located on the abdominal myotomes with common innervation with the uterine nerves: ST28 (Shuidao) & ST29 (Guilai) located on myotomes T12/L1 and two points located on the distal myotomes with common innervation with the uterine nerves: SP6 (Sanyinjiao) located on S2 myotome & LIV3 (Taichong) located on S3 myotome) Bilaterally and reaching De Qi, the needles will be connected to the electroacupuncture (electrical stimulation) device (abdominal points on each side together and distal points on each side together) and will be stimulated for thirty minutes with a frequency of eighty hertz and a wavelength of one hundred And eighty microseconds and with continuous mode. The intensity of the electric current starts from three milliamps and can be increased until the patient does not feel pain. Intervention 2: Second Intervention group: In the manual acupuncture group, after inserting the needles in the specified acupoints and reaching De Qi, the needles will remain in place for thirty minutes without stimulation. acupoints of this group:LU7 (Lieque) right hand, ST25 (Tianshu), ST28 (Shuidao), ST36 (Zusanli), ST40 (Fenglong), SP4 (Gongsun) right foot, SP6 (Sanyinjiao), SP10 (Xuehai), KI6 (Zhaohai) left foot, KI14 (Siman), PC6 (Neiguan) left hand,LIV3 (Taichong), LIV8 (Ququan), CV 3 (Zhongji),CV4 (Guanyuan), CV6 (Qihai), EX-CA1 (Zigong), N-CA-18 (Tituo) In order to maintain the blinding process, the needles will be connected to the electroacupuncture device in a similar way to the first group, but no stimulation will be induced and we will only use the beep sound of the device. Intervention 3: Control group: In Sham acupuncture group, Streitberger placebo needles will be used bilaterally in the same points as in segmental electric acupuncture group. These needles do not have the ability to penetrate the skin and will enter into their handle after a gentle tap while placing them on the skin. the needle handle will be connected to the electroacupuncture machine in the same way as the electroacupuncture group, with the difference that no stimulation is induced and we will only use the beep sound of the machine to resemble the electroacupuncture model and maintain the blinding process. Yes - There is a plan to make this available What will be shared: Information on primary outcomes and secondary outcomes can be shared from the Participant Data File item. The study protocol and clinical study report will be published in full The informed consent form can be shared in raw form When: The protocol is ready to be published Other documents are going to be published after the survey is finished To whom: University professors, university students and researchers Conditions: Application of data in order to use them in future surveys and also their application in treatment of patients Where to obtain: Dr.Hoda Azizi (azizih@mums.ac.ir) Dr.Elham Hooshyarazar (hooshyare991@mums.ac.ir) How to obtain: An e-mail is needed to be sent to the above mentioned persons Comments:
public Elham Hooshyarazar
Daneshgah street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 hooshyare991@mums.ac.ir Mashhad University of Medical Sciences scientific Hoda Azizi
Daneshgah street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 azizih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Non virgin females aged 18 until menopause Females who have uterine fibroids type 1-6 according to contemporary medicine standards Signing the informed consent form No need for immediate or emergency surgery intervention Being able to come to acupuncture clinic twice a week for 8 weeks Not suffering from adenomyosis or other genitourinary malignancies Non pregnant and not breastfeeding Not consuming hormonal drugs and drugs which can affect results of this study since 3 months ago Not suffering from severe heart / hepatic / renal failure No history of epilepsy Not participating in other acupuncture based studies Non smokers, not consuming alcohol Not suffering from uncontrolled diabetes and Hypertension Not having Hb bellow 10 mg/dl 18 years no limit Female Mismatching with the inclusion criteria after the start of the intervention (such as the need to take hormonal drugs or emergency surgery) Getting adenomyosis, genitourinary malignancies, severe heart/ hepatic/ renal failure and seizure during the study Not willing to get acupuncture for any reason Being absent from more than two consecutive treatment sessions Getting pregnant during the study D25 Leiomy A benign smooth muscle neoplasm arising from the body of the uterus. It is characterized by the presence of spindle cells with cigar-shaped nuclei, interlacing fascicles, and a whorled pattern.Uterine fibroids are the most common non-cancerous tumors in w Treatment - Devices Treatment - Devices Treatment - Devices First Intervention group: In the segmental electroacupuncture group, after inserting the needles in their predefined acupoints (two points located on the abdominal myotomes with common innervation with the uterine nerves: ST28 (Shuidao) & ST29 (Guilai) located on myotomes T12/L1 and two points located on the distal myotomes with common innervation with the uterine nerves: SP6 (Sanyinjiao) located on S2 myotome & LIV3 (Taichong) located on S3 myotome) Bilaterally and reaching De Qi, the needles will be connected to the electroacupuncture (electrical stimulation) device (abdominal points on each side together and distal points on each side together) and will be stimulated for thirty minutes with a frequency of eighty hertz and a wavelength of one hundred And eighty microseconds and with continuous mode. The intensity of the electric current starts from three milliamps and can be increased until the patient does not feel pain. Second Intervention group: In the manual acupuncture group, after inserting the needles in the specified acupoints and reaching De Qi, the needles will remain in place for thirty minutes without stimulation. acupoints of this group:LU7 (Lieque) right hand, ST25 (Tianshu), ST28 (Shuidao), ST36 (Zusanli), ST40 (Fenglong), SP4 (Gongsun) right foot, SP6 (Sanyinjiao), SP10 (Xuehai), KI6 (Zhaohai) left foot, KI14 (Siman), PC6 (Neiguan) left hand,LIV3 (Taichong), LIV8 (Ququan), CV 3 (Zhongji),CV4 (Guanyuan), CV6 (Qihai), EX-CA1 (Zigong), N-CA-18 (Tituo) In order to maintain the blinding process, the needles will be connected to the electroacupuncture device in a similar way to the first group, but no stimulation will be induced and we will only use the beep sound of the device. Control group: In Sham acupuncture group, Streitberger placebo needles will be used bilaterally in the same points as in segmental electric acupuncture group. These needles do not have the ability to penetrate the skin and will enter into their handle after a gentle tap while placing them on the skin. the needle handle will be connected to the electroacupuncture machine in the same way as the electroacupuncture group, with the difference that no stimulation is induced and we will only use the beep sound of the machine to resemble the electroacupuncture model and maintain the blinding process. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on mass size of dominant uterine fibroids before, immediately after intervention and in a 2 month follow-up. Timepoint: Before, immediately after intervention, 2 month after intervention. Method of measurement: Transvaginal doppler ultrasound. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on resistance index of uterine arteries before, immediately after intervention and in a 2 month follow-up. Timepoint: Before, immediately after intervention, 2 month after intervention. Method of measurement: Transvaginal doppler ultrasound. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on pulsatility index of uterine arteries before, immediately after intervention and in a 2 month follow-up. Timepoint: Before, immediately after intervention, 2 month after intervention. Method of measurement: Transvaginal doppler ultrasound. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on diameter of uterine arteries before, immediately after intervention and in a 2 month follow-up. Timepoint: Before, immediately after intervention, 2 month after intervention. Method of measurement: Transvaginal doppler ultrasound. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on intensity and regularity of menstrual bleeding in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on pelvic tightness or pressure in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on frequent urination during daytime in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on frequent nighttime urination in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on feeling fatigued in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on concerns of patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on activities of patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on energy and mood of patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on control in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on self-consciousness in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Evaluation and comparison of the effects of Segmental Electroacupuncture, Manual Acupuncture and Sham Acupuncture on sexual function in patients with uterine fibroids before, immediately after intervention and in in a 2 month follow-up. Timepoint: before, immediately after intervention and in in a 2 month follow-up. Method of measurement: UFS-QOL questionnaire. Mashhad University of Medical Sciences Approved 2023-10-22 Ethics committee of Mashhad university of medical sciences Daneshgah street, Ghorashi building (central building of Mashhad university of medical sciences) Mashhad Razavi Khorasan Iran (Islamic Republic of)