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Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women

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History
# Registration date Revision Id
2 2021-07-03, 1400/04/12 188921
1 2020-09-20, 1399/06/30 151595
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  • General information

    60
    46
    60
    46
    2019-09-23, 1398/07/01
    2020-09-22, 1399/07/01
    2020-03-10, 1398/12/20
    2021-03-10, 1399/12/20
    2019-09-23, 1398/07/01
    2020-09-22, 1399/07/01
    2020-03-10, 1398/12/20
    2021-03-10, 1399/12/20
    2020-04-18, 1399/01/30
    2021-04-19, 1400/01/30
    empty
    Error in data entry
    empty
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Protocol summary

Study aim
-Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women referring to Yas Hospital in 2019
Design
Controlled parallel randomized clinical trial on 60 patients
Settings and conduct
A total of 60 women with chronic pelvic pain, 30 patients in radiofrequency intervention group and 30 patients in physiotherapy intervention group, are included in this study in Yas Hospital, Tehran, iran. The intervention is heat controlled radiofrequency or physiotherapy for treatment of chronic pelvic pain. Finally, the intensity of pain, pelvic floor muscle strength, pelvic floor muscle tonicity and muscle endurance are compared between groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic pelvic pain. Exclusion criteria: using drugs for treatment of chronic pelvic pain.
Intervention groups
Intervention group includes women with chronic pelvic pain that are treated with heat controlled radiofrequency or physiotherapy.
Main outcome variables
Pain; Pelvic floor strength; Pelvic floor tonicity; Muscle endurance

General information

Reason for update
Error in data entry
Acronym
IRCT registration information
IRCT registration number: IRCT20200311046746N2
Registration date: 2020-09-20, 1399/06/30
Registration timing: prospective

Last update: 2021-07-03, 1400/04/12
Update count: 1
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Nasim Shokouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4116 0852
Email address
shokouhinasim@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2021-03-10, 1399/12/20
Trial completion date
2021-04-19, 1400/01/30
Scientific title
Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women
Public title
Comparison of the effects of heat controlled radiofrequency with physiotherapy on chronic pelvic pain in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic pelvic pain
Exclusion criteria:
Medication for treatment of chronic pelvic pain Pelvic region malignancies Pregnancy, breastfeeding, and other related medical conditions Urinary tract infections and vaginal infections Neurological disease such as MS, CVA, and spinabifida Abnormal mental status Abnormal pap smear
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Actual sample size reached: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated into the case and control groups using permuted balance block randomization. The blocks are four. Using STATA software, random numbers are generated from 1 to 6. Another number is generated when the previous number is more than 6, without considering it. An individual prepare the random numbers and put them in pockets with a five-digit serial number. All pockets open after including a patient, and the patient allocates to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina Avenue
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷-۱۳۱۳۷
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.162

Health conditions studied

1

Description of health condition studied
Chronic pelvic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention, after 6 weeks and after 3 months
Method of measurement
Visual analog scale

2

Description
Pelvic floor muscle strength
Timepoint
Before the intervention, after 6 weeks and after 3 months
Method of measurement
Clinical examination

3

Description
Pelvic floor muscle tonicity
Timepoint
Before the intervention, after 6 weeks and after 3 months
Method of measurement
Clinical examination

4

Description
Muscle endurance
Timepoint
Before the intervention, after 6 weeks and after 3 months
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Radiofrequency treatment. Patients undergo a Radiofrequency twice a month for 12 weeks in Yas hospital, Tehran. Each session we are going to assess patients satisfaction using VAS.
Category
Treatment - Other

2

Description
Intervention group: Physiotherapy treatment. Patients undergo a Physiotherapy once a week for 12 weeks in Yas hospital, Tehran. Each session we are going to assess patients satisfaction using VAS.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Nasim Shokouhi
Street address
North Nejatollahi street , karim khan avenue
City
Teharn
Province
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Email
yashospital@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Qods street, Keshavars blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۳۷
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nasim Shokouhi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatolahi street, Karimkhan street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
yashospital@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasim Shokouhi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatolahi street, Karimkhan street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
yashospital@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasim Shokouhi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatolahi street, Karimkhan street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
yashospital@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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