Providing a method for possible better exposure to pain in endometriosis patients
Design
A clinical trial with a control group. Randomized by drawing a card. Phase 2 on 100 patients.
Settings and conduct
This study is a randomized clinical trial. The participants are selected from the outpatient endometriosis clinic of Taleghani Hospital in 1403 and all of them sign an informed consent period. The participants are randomly divided into two groups (Dinogest treatment along with pelvic physiotherapy) and the control group (Dinogest treatment and Maneuver Sham) are placed.
And in both cases, the pain caused by dysmenorrhea, dyschezia, and dyspareunia will be evaluated using the Visual Analogue Scale method.
And the questionnaire is filled based on it.
Pelvic floor physiotherapy will be performed for 12 fifty-minute sessions, repeated three times a week.
These women were instructed not to stop endometriosis medication during the study.
Randomization is done and after three months, the pain score is evaluated based on their VAS and filled in the questionnaire and compared with the previous three months.
Participants/Inclusion and exclusion criteria
Include criteria:Women aged 20-45 with endometriosis
All of them have been using dinogest for at least 3 months.
reported symptoms of pelvic pain (CPP or dyspareunia and dysmenorrhea).
Exclude criteria: Pregnancy, pace maker, , epilepsy, cardiac arrhythmia, cancer, acute pelvic inflammatory disease, difficulty understanding instructions.
Intervention groups
Participants will be randomly assigned to two groups (dienogest treatment plus pelvic physiotherapy) and a control group (dienogest treatment and sham maneuver).
In both groups, pain due to dysmenorrhea, dyspareunia, and dyspareunia will be assessed using the Visual Analogue Scale.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241107063631N1
Registration date:2024-12-03, 1403/09/13
Registration timing:registered_while_recruiting
Last update:2024-12-03, 1403/09/13
Update count:0
Registration date
2024-12-03, 1403/09/13
Registrant information
Name
maral hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 9143
Email address
maral.hosseinzadeh65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-17, 1403/08/27
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Dienogest with and without pelvic floor physiotherapy on the pain level of endometriosis sufferers.
Public title
The effect of pelvic physiotherapy in reducing pain in patients with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20-45 with endometriosis.
All of them have been using dinogest for at least 3 months
All of them reported symptoms of pelvic pain (CPP or dyspareunia and dysmenorrhea).
Exclusion criteria:
pregnancy
Pace maker
Reduced skin sensitivity, , acute , cognitive impairment, and
Epilepsy,
Cardiac arrhythmia
Cancer
Acute pelvic inflammatory disease
Gel or electrode sensitivity,
difficulty understanding instructions
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Sequence Generation will be done by simple randomization and by shuffling the cards. A number of cards will be prepared as the first group and the same number of cards for the next groups. Then, by shuffling them, one card will be removed and its assignment will be recorded, and that card will be returned to the other cards. Then, the cards will be shuffled again and another card will be removed. This process will continue until a random sequence is reached according to the sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
taleghani hospital . Arabi street . daneshjoo street
City
tehran
Province
Tehran
Postal code
1115119857
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.430
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.3
ICD-10 code description
Endometriosis of pelvic peritoneum
Primary outcomes
1
Description
Pain score in the questionnaire
Timepoint
Before the start of the intervention - one month after the start of physiotherapy
Method of measurement
mode Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dienogest treatment with pelvic physiotherapy - Pelvic floor physiotherapy will be performed for 12 sessions of fifty minutes, repeated three times a week. It includes thirty minutes of visceral manipulation (internal vaginal and external (abdomen) and twenty minutes of pelvic floor muscle exercises. The patient is placed in a supine position with bent knees. Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises for adequate understanding of the exercises and performing fast and slow contractions. The simple phase is performed in the second week with the aim of improving the control of fast and slow contractions during simple functional activities. The advanced phase is performed in the third week in which functional exercises with a greater amplitude are performed. The strength phase is performed in the last week to increase the strength of contraction. In all sessions, contractions will be performed for slow and fast fibers.
Category
Treatment - Other
2
Description
Control group: Dienogest treatment and sham maneuver (a dummy intervention is used as an intervention in the control group, and the practical methods are applied in a fake manner in the control group). Dienogest was also prescribed from Ati Pharmed Pharmaceutical Company at a dose of 2 mg daily.