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
Evaluation of the effect of Acupuncture on patients with uterine fibroids
Design
Randomized, superiority, parallel, three group trial ( 2 intervention and one control group) with 24 patients in each group, single blinded,
Randomization type: Block,
Method used to generate the random allocation sequence: envelope
Settings and conduct
Location :Acupuncture clinic of Imam Reza hospital in Mashhad.
Patients, analyzers, statisticians and radiologist will be blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: non virgin females aged 18 until menopause-having uterine fibroids type 1-6 according to contemporary medicine standards-signing the informed consent form-no need for emergency surgery intervention-able to come to acupuncture clinic twice a week for 8 weeks-not having adenomyosis or other genitourinary malignancies, severe heart / hepatic / renal failure, epilepsy, uncontrolled diabetes and hypertension-non pregnant and not breastfeeding-not consuming hormonal drugs and drugs affecting results of this study since 3 months ago-not participating in other acupuncture based studies-non smokers, not consuming alcohol-not having Hb bellow 10 mg/d
Exclusion criteria:
1-mismatching with the inclusion criteria after the start of the intervention -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 sessions-getting pregnant during the study
Intervention groups
Segmental Electroacupuncture group, Manual Acupuncture group, Sham Acupuncture group
Main outcome variables
Tumor size, diameter, pulsatility index and resistance index of uterine arteries
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110809007265N14
Registration date:2023-11-01, 1402/08/10
Registration timing:registered_while_recruiting
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation and comparison of the effects of electroacupuncture and manual acupuncture on uterine fibroids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Daneshgah street, Ghorashi building (central building of Mashhad university of medical sciences)
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.MUMS.REC.1402.216
Health conditions studied
1
Description of health condition studied
Leiomyoma
ICD-10 code
D25 Leiomy
ICD-10 code description
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
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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
9
Description
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
10
Description
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
11
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
3
Description
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.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Hooshyarazar
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Acupuncture
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
hooshyare991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoda Azizi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Acupuncture
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
azizih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham hooshyarazar
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Acupuncture
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
hooshyare991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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 data will become available and for how long
The protocol is ready to be published
Other documents are going to be published after the survey is finished
To whom data/document is available
University professors, university students and researchers
Under which criteria data/document could be used
Application of data in order to use them in future surveys and also their application in treatment of patients