IRCT | Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhoea and dysparonychia caused by endometriosis in women.

Protocol summary

Study aim: Comparison of standard treatment of classical medicine and embedding in the control of dysmenorrhea and dysparonychia caused by endometriosis in women.
Design: Considering the VAS scale as the primary outcome, the smallest improvement difference based on this scale is -3.9, and based on previous studies, the standard deviation is 1.7 and the difference between the two treatments is 3. The sample size for each group is 44 people, considering The drop rate will be calculated in a sample size of 50 people in each group. To determine the relationship between individual characteristics and the effect of the intervention, multivariate statistical tests including two-way analysis of variance will be used. In addition, sensitivity analyzes will be performed based on the desired subgroups. All analyzes will be performed at a significance level of 5% and a confidence level of 95%. SPSS software version 24 will be used for data analysis. This study will be double-blinded (examiner and analyst) and with limited randomization of block randomization type.
Settings and conduct: Acupuncture Clinic of Imam Reza Hospital
Participants/Inclusion and exclusion criteria: Entry criteria Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, fixed and immobile uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules) Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during complaining of dysmenorrhea with EAPP score >30 or >40. Normal prolactin level, normal pap smear Age 18-45 years Informed written consent to participate in the study
Intervention groups: Women with endometriosis aged 18 to 45
Main outcome variables: Dysmenorrhea and dyspareunia; serum level of anti mullerian hormone and antral follicle count (primary outcome); quality of life secondary outcome

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20121228011912N5

Registration date: 2023-05-10, 1402/02/20

Registration timing: prospective

Last update: 2023-05-10, 1402/02/20

Update count: 0
Registration date: 2023-05-10, 1402/02/20

Registrant information: Name

Hamidreza Bahrami Taghanaki

Name of organization / entity

Mashhad University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 51 1841 5666

Email address

bahramihr@mums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-05-22, 1402/03/01
Expected recruitment end date: 2023-11-21, 1402/08/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhoea and dysparonychia caused by endometriosis in women.

Public title: Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhea and dyspareunia caused by endometriosis in women
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules) Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months Dysmenorrhea complaint with EAPP score >30 or >40 normal pap smear Age 18-45 years Informed written consent to participate in the study

Exclusion criteria:

Unwillingness to continue the research Non-adherence to the provided treatment regimen and incorrect or incomplete use of medication Occurrence of any complications attributed to drug use (especially allergies) Endometriosis who were treated with GNRH agonist less than 6 months ago, or danazol or progesterone pills less than 3 months ago, or birth control pills less than one month ago Breastfeeding, pregnancy. Cancers of the uterus, ovaries, cervix and high-grade intraepithelial lesions
Age: From 18 years old to 45 years old
Gender: Female

Phase

3

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

Using the online site https://www.sealedenvelope.com, random allocation will be placed in two groups: A, classical medicine, and B, embedding. Randomization will be done based on Block Randomization with blocks of 4. The random allocation of 12 blocks of 4 will be as follows. The prepared blocks will be placed in the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and based on the obtained blocks, 4 patients will be assigned to two groups.

Blinding (investigator's opinion)

Double blinded

Blinding description

Using the online site https://www.sealedenvelope.com, random allocation will be placed in two groups: A, classical medicine, and B, embedding. Randomization will be done based on Block Randomization with blocks of 4. The random allocation of 12 blocks of 4 will be as follows. The prepared blocks will be placed inside the envelope. According to the order of patients' entry, one of the envelopes will be randomly selected and based on the obtained blocks, 4 patients will be assigned to two groups. Then, the collaboration, which is blind to the type of interventions, will check all patients in terms of entry and exit criteria, and then Forms and questionnaires are completed and primary and secondary outcomes are determined for those eligible

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Mashhad University of Medical Sciences (Research Ethics Committee)

Street address

3rd floor - Abuzar qafari Bulv - Abuzar qafari 38- Ahmad Abad Ave.

City

mashhad

Province

Razavi Khorasan

Postal code

9176716584
Approval date: 2023-04-07, 1402/01/18
Ethics committee reference number: IR.MUMS.REC.1402.020

Health conditions studied

1

Description of health condition studied: dysmenorrhea and dyspareunia caused by endometriosis
ICD-10 code: N80.9
ICD-10 code description: Endometriosis, unspecified

Primary outcomes

1

Description: Dysmenorrhea and dyspareunia
Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later
Method of measurement: It will be evaluated using the EAPP checklist scale

2

Description: Anti-Müllerian hormone serum level and antral follicle count
Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later
Method of measurement: Measurement of anti-Müllerian hormone serum level and antral follicle count by ultrasound

Secondary outcomes

1

Description: Quality of Life
Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later
Method of measurement: Short form of World Health Organization quality of life questionnaire

Intervention groups

1

Description: Intervention group: Embedding in women with dysmenorrhoea and dysparonychia caused by endometriosis in reproductive age. Acupuncture embedding is a new and emerging method developed in the fields of acupuncture and embedding needle. This method has immediate and long-lasting effects on the human body, compensates for the short duration of acupuncture stimulation and reduces the number of times patients visit the doctor.
Category: Treatment - Devices

2

Description: Intervention group: Intervention group: The classical medicine group will be treated with one continuous and regular daily LD pill for a period of three months and from the same day (the first day of the menstrual cycle).
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Acupuncture Clinic, Mashhad University of Medical Sciences

Full name of responsible person

Hamidreza Bahrami Taganki

Street address

Ebne Sina street

City

Mashhad

Province

Razavi Khorasan

Postal code

91379-13316

Phone

+98 51 3854 3031

Email

imamreza@mums.ac.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr. Majid Ghayour-Mobarhan

Street address

Daneshgah Street

City

Mashhad

Province

Razavi Khorasan

Postal code

9138813944

Phone

+98 51 3841 1538

Email

GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
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

Dr. Hamidreza Bahrami-Taghanaki

Position

Faculty member

Latest degree

Ph.D.

Other areas of specialty/work

Traditional Medicine

Street address

Ebne Sina Street

City

Mashhad

Province

Razavi Khorasan

Postal code

9184166750

Phone

+98 51 3884 8931

Email

bahramihr@mums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr. Hamidreza Bahrami-Taghanaki

Position

Faculty member

Latest degree

Ph.D.

Other areas of specialty/work

Traditional Medicine

Street address

Ebne Sina street

City

Mashhad

Province

Razavi Khorasan

Postal code

9184166750

Phone

+98 51 3841 1538

Email

bahramihr@mums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr. Hamidreza Bahrami-Taghanaki

Position

ّFaculty member

Latest degree

Ph.D.

Other areas of specialty/work

Traditional Medicine

Street address

Imam Reza Hospital - Ebne Sina Street

City

Mashhad

Province

Razavi Khorasan

Postal code

9184166750

Phone

+98 51 3841 1538

Email

bahramihr@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: Yes - There is 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: Not applicable
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: The statistical details of the data will be mentioned in the published article.
When the data will become available and for how long: After finishing research
To whom data/document is available: All those who have access to the published article or with the supervisory permission of the Vice Research of Mashhad University of Medical Sciences
Under which criteria data/document could be used: With the request of the responsible researcher and the consent of the University Research Council and only for survey purposes without any possibility of exploiting the content of the data.
From where data/document is obtainable: After printing the article to the responsible author and before printing, if required by relevant authorities, to the responsible researcher
What processes are involved for a request to access data/document: By means if Vice research of Mashhad University of Medical Science
Comments

Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhoea and dysparonychia caused by endometriosis in women.