Protocol summary

Study aim
The use of physiotherapy in the treatment of patients with symptoms of pain and infertility and sexual disorders in women with endometrial thickness less than 7 mm
Design
A clinical trial with a control group, double-blind, randomized on 40 patients, rand function of Excel software was used for randomization.
Settings and conduct
Conducted in a private clinic, patients are included in the study with the approval of the associate doctor, the physiotherapist is asked to check the sacroiliac joint alignment so that if the joint alignment of the patients is normal, the patients are included in the study. An individual consent form is received from the patients and they are told that they can be excluded from the study if they do not want to cooperate. They are entered randomly in the intervention and control groups, and manual techniques on the uterus and abdomen are performed in the intervention group and routine physical therapy is performed in the control group. After the completion of the treatment, the patients are again evaluated by ultrasound on the third to sixth day, and the form of pain and sexual function completes اطلاعات بیشتر درباره این نوشتار مبدأبرای اطلاعات ترجمه بیشتر، نوشتار مبدأ لازم است ارسال بازخورد پانل‌های کناری
Participants/Inclusion and exclusion criteria
Patient with thin endometrium ,not pregnant ,not malignant,
Intervention groups
Performing physical therapy manual techniques on abdominal muscles and receiving vitamin E in patients and the control group receiving vitamin E and routine physical therapy
Main outcome variables
Thickness of uterus endometrium,pain and sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220520054928N1
Registration date: 2022-10-29, 1401/08/07
Registration timing: retrospective

Last update: 2022-10-29, 1401/08/07
Update count: 0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Hanyeh Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6606 7281
Email address
hanyehhabibi2694@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-19, 1401/05/28
Expected recruitment end date
2022-09-19, 1401/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of physical therapy manual techniques (visceral manipulation) on uterine endometrial thickness, pain and investigating the quality of sexual function in women in women with endometrial thickness less than 7 mm
Public title
Physiotherapy in thin endometrium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Thickness od endometrium is lesser than 7mm Patient is married
Exclusion criteria:
Non malegnancy Not pregnant
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by block
Blinding (investigator's opinion)
Single blinded
Blinding description
physical therapist
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Rehabilitation Sciences and Social Health
Street address
Kodakyar Ave., Daneshjo Blvd., Evin, Velenjak.Tehran.Iran
City
Tehran
Province
Tehran
Postal code
145443564
Approval date
2022-05-20, 1401/02/30
Ethics committee reference number
IR.USWR.REC.1401.028

Health conditions studied

1

Description of health condition studied
Thin uterus endometrium
ICD-10 code
N71.9
ICD-10 code description
Inflammatory disease of uterus, unspecified

Primary outcomes

1

Description
Uterine endometrial thickness in women with endometrial thickness less than 7 mm
Timepoint
Assessment in days of3_6in peroid cycle
Method of measurement
Sonography,visual analogue scale ,and form of sexual dysfunction

2

Description
pain higher than score five in visual pain measurement
Timepoint
At the beginning of the study and after the completion of treatment
Method of measurement
Visual analogue scale

3

Description
Investigating the quality of women's sexual performance using a sexual performance questionnaire
Timepoint
At the beginning of the study and after the completion of treatment
Method of measurement
Questionnaire form for assessing the quality of women's sexual performance

Secondary outcomes

1

Description
Endometrial thickness, and investigating the effect of physiotherapy in gynecological diseases and infertility
Timepoint
Post of treatment in 3_6days of perid
Method of measurement
Sonography,

Intervention groups

1

Description
Control group: vitamin E group of patients are randomly divided into intervention and control groups, there are twenty people in each group. In both control and treatment groups, vitamin E400 is taken orally twice a week. In addition to vitamin E, the intervention group also receives visceral manipulation techniques. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up.
Category
Treatment - Other

2

Description
Intervention group: Intervention group: In addition to vitamin E, visceral manipulation techniques are also performed in the intervention group. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal clinic
Full name of responsible person
Dr .Zahra Mossallanezad
Street address
No 19, Tofigh Alley ,Vandad clinic, Zaferanieh
City
Tehran
Province
Tehran
Postal code
14555698
Phone
+98 21 2272 8421
Email
hanyehhabibi2694@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Amir Masoud Arab
Street address
Kodakyar Ave., Daneshjo Blvd., Evin, velenjak.tehran.iran
City
Tehran
Province
Tehran
Postal code
144456858
Phone
+98 21 2218 0033
Email
hanyehhabibi2694@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Mosslanezhad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Ave,Daneshjo Blvd,Evin
City
Tehran
Province
Tehran
Postal code
14555858668
Phone
+98 21 2218 0032
Email
zmosallanezhad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammedreza Norbakhsh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kodakyar Ave,Daneshjo Blvd,Evin
City
Tehran
Province
Tehran
Postal code
1455556585
Phone
+98 21 2218 8003
Email
hanyehhabibi2694@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hanyeh Habibi
Position
MScs student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No19, Akbari Street , Azadi Square
City
Tehran
Province
Tehran
Postal code
13456586858
Phone
+98 21 6606 7281
Email
hanyehhabibi2694@gmail.com

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Document with out name and number
When the data will become available and for how long
Start in six months after end of research
To whom data/document is available
University and academic research
Under which criteria data/document could be used
Use od analysis process
From where data/document is obtainable
USWR university
What processes are involved for a request to access data/document
Resquated in USWR.univercity
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